xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05975606</url>
    </required_header>
    <id_info>
      <org_study_id>122650</org_study_id>
      <nct_id>NCT05975606</nct_id>
    </id_info>
    <brief_title>Non-invasive Brain Stimulation Paired With FES Cycling Post SCI</brief_title>
    <official_title>Exploring the Effect of Non-invasive Brain Stimulation Paired With Functional Electrical Stimulation to Improve Lower Extremity Function Following Incomplete Spinal Cord Injury</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Western University, Canada</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Western University, Canada</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This project is randomized controlled trial which will explore the effect of pairing&#xD;
        repetitive Transcranial Magnetic Stimulation (rTMS) with Functional Electrical Stimulation&#xD;
        (FES) Cycling on lower extremity function in people with incomplete spinal cord injury and&#xD;
        compare the effects to each one of these interventions alone.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Following a spinal cord injury, people often have decreased strength and balance in their&#xD;
        legs, making it difficult to walk. To improve leg function in people with spinal cold&#xD;
        injuries, the investigators can use electrical stimulation on muscles while participants are&#xD;
        cycling to increase the muscle activation and nerve connections. Another way to improve the&#xD;
        nerve connections to the muscles is by stimulating the brain directly. Previous research has&#xD;
        looked at the effects of each of these treatments, but they have not been used together. In&#xD;
        this study, the investigators will pair both electrical stimulation on the legs during&#xD;
        cycling with brain stimulation or a sham brain stimulation to improve recovery and determine&#xD;
        if using these methods together results in better outcomes, such as increased walking speed.&#xD;
        Participants will attend training sessions for six weeks, twice per week. Each person will&#xD;
        first receive the active or sham brain stimulation at the beginning of the session for 30&#xD;
        minutes and then they will receive the electrical stimulation on their legs while cycling for&#xD;
        60 minutes. Participants will be evaluated before the start of the treatment, in the middle&#xD;
        of the study, at the final session, and again two weeks after the last session of the&#xD;
        treatment. Assessments will include clinical tests of gait, balance, and strength. Inertial&#xD;
        Measurement Units (IMU) and a pressure sensor gait mat will be used to evaluate the gait and&#xD;
        balance parameters.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>This protocol involves two groups of participants: intervention group and control group. Intervention group will receive real rTMS and FES cycling and control group will receive sham rTMS and FES cycling. The results of these groups are then evaluated at several stages of the study.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
      <masking_description>Participants are blinded to their groups. Research assistant and physiotherapist who are responsible for conducting assessment sessions are also blinded to participants group.&#xD;
  All the participants will be randomized to groups using opaque envelopes blocked by four and stratified by AIS score.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Time taken to complete the recruitment of 12 participants</measure>
      <time_frame>8 weeks</time_frame>
      <description>This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the feasibility of the protocol.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of participants recruited from the total number screened</measure>
      <time_frame>8 weeks</time_frame>
      <description>This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the feasibility of the protocol.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of sessions attended by each participant</measure>
      <time_frame>8 weeks</time_frame>
      <description>This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of dropouts in each group</measure>
      <time_frame>8 weeks</time_frame>
      <description>This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Willingness of participants to undergo therapy</measure>
      <time_frame>8 weeks</time_frame>
      <description>This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol. The willingness of participation will be collected on an 11-point numerical rating scale with 'not at all willing' at 0, and 'very willing' at 10 (measured at baseline).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of treatment-emergent adverse events</measure>
      <time_frame>8 weeks</time_frame>
      <description>This outcome will be evaluated through descriptive data. Safety will be presented as any adverse reaction reported on verbal questioning at each session. The number of participants reporting adverse reactions, and the duration and severity of the adverse reactions will be reported.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Walking speed</measure>
      <time_frame>8 weeks</time_frame>
      <description>This instrumental outcome is collected using a pressure sensor gait mat.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Step length</measure>
      <time_frame>8 weeks</time_frame>
      <description>This instrumental outcome is collected using a pressure sensor gait mat.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Step width</measure>
      <time_frame>8 weeks</time_frame>
      <description>This instrumental outcome is collected using a pressure sensor gait mat.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cadence</measure>
      <time_frame>8 weeks</time_frame>
      <description>This instrumental outcome is collected using a pressure sensor gait mat.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Timed Up and Go (TUG) test</measure>
      <time_frame>8 weeks</time_frame>
      <description>This instrumental outcome will be collected using Inertial Measurement Units (IMUs).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sit-to-stand test</measure>
      <time_frame>8 weeks</time_frame>
      <description>This instrumental outcome will be collected using Inertial Measurement Units (IMUs).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postural sway test</measure>
      <time_frame>8 weeks</time_frame>
      <description>This instrumental outcome will be collected using Inertial Measurement Units (IMUs).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lower Extremity Motor Score (LEMS)</measure>
      <time_frame>8 weeks</time_frame>
      <description>A blinded physiotherapist will be hired to collect this clinical outcome.&#xD;
  Lower Extremity Motor Score is rated from 0 to 5* as follows:&#xD;
  0= Total paralysis&#xD;
  Palpable or visible contraction&#xD;
  Active movement, full range of motion (ROM) when gravity is eliminated&#xD;
  Active movement, full ROM against gravity&#xD;
  Active movement, full ROM against gravity, and moderate resistance in muscle-specific position&#xD;
  (Normal) Active movement, full ROM against gravity, and full resistance in a muscle-specific position expected from a healthy person 5*= (Normal) Active movement, full ROM against gravity, and sufficient resistance to be considered normal if identified inhibiting factors (i.e., pain, disuse) were not present NT = Not testable (i.e., due to immobilization, sever pain that can prevent the grading of the patient, amputation of the limb, or contracture of &gt;50% of the range of motion) Higher scores in this outcome mean better result.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Walking Index for Spinal Cord Injury (WISCI) II scale</measure>
      <time_frame>8 weeks</time_frame>
      <description>A blinded physiotherapist will be hired to collect this clinical outcome. Walking Index for Spinal Cord Injury version II scale is rated from 0 to 20 with the higher scores showing better results.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Global Rating of Change (GRC) scale</measure>
      <time_frame>8 weeks</time_frame>
      <description>Evaluation of the participants' impact will be collected through a GRC questionnaire in each assessment session.&#xD;
  Global Rating Scale will ask participants to rate their walking abilities and overall recovery of the lower limb function from the time that they began the treatment until now. This scale is rated from -7 to 7 as follows:&#xD;
  7: A very great deal worse&#xD;
  6: A great deal worse&#xD;
  5: Quite a bit worse&#xD;
  4: Moderately worse&#xD;
  3: Somewhat worse&#xD;
  2: A little bit worse&#xD;
  1: A tiny bit worse (almost the same) 0: About the same&#xD;
  1: A tiny bit better (almost the same)&#xD;
  2: A little bit better&#xD;
  3: Somewhat better&#xD;
  4: Moderately better&#xD;
  5: Quite a bit better&#xD;
  6: A great deal better&#xD;
  7: A very great deal better&#xD;
  Higher scores in this outcome mean better results.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">14</enrollment>
    <condition>Incomplete Spinal Cord Injury</condition>
    <arm_group>
      <arm_group_label>Treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants of this group will receive active rTMS along with real FES cycling.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Participants of this group will receive sham rTMS along with real FES cycling.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>repetitive transcranial magnetic stimulation (rTMS)</intervention_name>
      <description>rTMS will be applied to primary motor cortex of the brain.</description>
      <arm_group_label>Treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>functional electrical stimulation (FES) cycling</intervention_name>
      <description>FES will be applied to muscles associated in cycling: quadriceps, hamstrings, tibialis anterior, gastrocnemius, soleus.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Treatment group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adult&#xD;
  &#xD;
            -  having motor incomplete SCI with level C or D on the American Spinal Injury&#xD;
               Association Impairment Scale (AIS) with the lesion at any level of the cord resulting&#xD;
               from either traumatic or non-traumatic etiology who are at least one-year post-injury.&#xD;
  &#xD;
            -  having non-progressive SCI&#xD;
  &#xD;
            -  being able to walk independently for 10 meters without help from another person&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  other orthopedic or neurological implications that affect the lower extremity function&#xD;
  &#xD;
            -  contraindications to FES (e.g., implanted electronic devices, unhealed bone fractures,&#xD;
               sever contractures, extreme osteoporosis or osteoarthritis)&#xD;
  &#xD;
            -  contraindications to rTMS (e.g., metal implants, history of seizure, cochlear&#xD;
               implants)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Siobhan Schabrun, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Western University, Canada</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Janelle Unger, PhD</last_name>
      <phone>+1-519 664-6100</phone>
      <phone_ext>45789</phone_ext>
      <email>janelle.unger@uwo.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Fereshteh Ghahremani, BSc</last_name>
      <phone>+1-647-622-4303</phone>
      <email>fghahrem@uwo.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Parkwood Institute</name>
        <address>
          <city>London</city>
          <state>Ontario</state>
          <zip>N6C 0A7</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Janelle Unger, PhD</last_name>
        <phone>+1-519-664-6100</phone>
        <phone_ext>45789</phone_ext>
        <email>janelle.unger@uwo.ca</email>
      </contact>
      <contact_backup>
        <last_name>Fereshteh Ghahremani, BSc</last_name>
        <phone>+1-647-622-4303</phone>
        <email>fghahrem@uwo.ca</email>
      </contact_backup>
      <investigator>
        <last_name>Siobhan Schabrun, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <reference>
      <citation>Ding W, Hu S, Wang P, Kang H, Peng R, Dong Y, Li F. Spinal Cord Injury: The Global Incidence, Prevalence, and Disability From the Global Burden of Disease Study 2019. Spine (Phila Pa 1976). 2022 Nov 1;47(21):1532-1540. doi: 10.1097/BRS.0000000000004417. Epub 2022 Jun 30.</citation>
      <PMID>35857624</PMID>
    </reference>
    <reference>
      <citation>Qin W, Bauman WA, Cardozo C. Bone and muscle loss after spinal cord injury: organ interactions. Ann N Y Acad Sci. 2010 Nov;1211:66-84. doi: 10.1111/j.1749-6632.2010.05806.x.</citation>
      <PMID>21062296</PMID>
    </reference>
    <reference>
      <citation>REED WB, PIDGEON J, BECKER SW. Patients with spinal cord injury. Clinical cutaneous studies. Arch Dermatol. 1961 Mar;83:379-85. doi: 10.1001/archderm.1961.01580090029002. No abstract available.</citation>
      <PMID>13740272</PMID>
    </reference>
    <reference>
      <citation>Riggins MS, Kankipati P, Oyster ML, Cooper RA, Boninger ML. The relationship between quality of life and change in mobility 1 year postinjury in individuals with spinal cord injury. Arch Phys Med Rehabil. 2011 Jul;92(7):1027-33. doi: 10.1016/j.apmr.2011.02.010.</citation>
      <PMID>21704781</PMID>
    </reference>
    <reference>
      <citation>Sadowsky CL, Hammond ER, Strohl AB, Commean PK, Eby SA, Damiano DL, Wingert JR, Bae KT, McDonald JW 3rd. Lower extremity functional electrical stimulation cycling promotes physical and functional recovery in chronic spinal cord injury. J Spinal Cord Med. 2013 Nov;36(6):623-31. doi: 10.1179/2045772313Y.0000000101. Epub 2013 Mar 20.</citation>
      <PMID>24094120</PMID>
    </reference>
    <reference>
      <citation>BARRIA P, AGUILAR R, DS D, MORIS A, ANDRADE A, JM A. Instrumented gait analysis of stroke patients after FES-cycling therapy.</citation>
    </reference>
    <reference>
      <citation>Benito J, Kumru H, Murillo N, Costa U, Medina J, Tormos JM, Pascual-Leone A, Vidal J. Motor and gait improvement in patients with incomplete spinal cord injury induced by high-frequency repetitive transcranial magnetic stimulation. Top Spinal Cord Inj Rehabil. 2012 Spring;18(2):106-12. doi: 10.1310/sci1802-106.</citation>
      <PMID>23459246</PMID>
    </reference>
    <reference>
      <citation>Fawaz S, Kamel F, El Yasaky A, El Shishtawy H, Genedy A, Awad RM, El Nabil L. The therapeutic application of functional electrical stimulation and transcranial magnetic stimulation in rehabilitation of the hand function in incomplete cervical spinal cord injury. Egyptian Rheumatology and Rehabilitation. 2019 Jan;46(1):21-6.</citation>
    </reference>
    <reference>
      <citation>Shariat A, Hosseini L, Najafabadi MG, Cleland JA, Shaw BS, Shaw I. Functional Electrical Stimulation and Repetitive Transcranial Magnetic Stimulation for Neurorehabilitation in Patients Post Stroke: A Short Communication. Asian Journal of Sports Medicine. 2018 Dec 31;9(4).</citation>
    </reference>
    <reference>
      <citation>Krogh S, Aagaard P, Jonsson AB, Figlewski K, Kasch H. Effects of repetitive transcranial magnetic stimulation on recovery in lower limb muscle strength and gait function following spinal cord injury: a randomized controlled trial. Spinal Cord. 2022 Feb;60(2):135-141. doi: 10.1038/s41393-021-00703-8. Epub 2021 Sep 9.</citation>
      <PMID>34504284</PMID>
    </reference>
    <reference>
      <citation>Alexeeva N, Calancie B. Efficacy of QuadroPulse rTMS for improving motor function after spinal cord injury: Three case studies. J Spinal Cord Med. 2016;39(1):50-7. doi: 10.1179/2045772314Y.0000000279. Epub 2014 Dec 1.</citation>
      <PMID>25437531</PMID>
    </reference>
    <reference>
      <citation>Kumru H, Benito J, Murillo N, Valls-Sole J, Valles M, Lopez-Blazquez R, Costa U, Tormos JM, Pascual-Leone A, Vidal J. Effects of high-frequency repetitive transcranial magnetic stimulation on motor and gait improvement in incomplete spinal cord injury patients. Neurorehabil Neural Repair. 2013 Jun;27(5):421-9. doi: 10.1177/1545968312471901. Epub 2013 Jan 15.</citation>
      <PMID>23322551</PMID>
    </reference>
    <reference>
      <citation>Kumru H, Benito-Penalva J, Valls-Sole J, Murillo N, Tormos JM, Flores C, Vidal J. Placebo-controlled study of rTMS combined with Lokomat(R) gait training for treatment in subjects with motor incomplete spinal cord injury. Exp Brain Res. 2016 Dec;234(12):3447-3455. doi: 10.1007/s00221-016-4739-9. Epub 2016 Jul 28.</citation>
      <PMID>27469242</PMID>
    </reference>
    <reference>
      <citation>Donaldson N, Perkins TA, Fitzwater R, Wood DE, Middleton F. FES cycling may promote recovery of leg function after incomplete spinal cord injury. Spinal Cord. 2000 Nov;38(11):680-2. doi: 10.1038/sj.sc.3101072.</citation>
      <PMID>11114775</PMID>
    </reference>
    <reference>
      <citation>Sloan KE, Bremner LA, Byrne J, Day RE, Scull ER. Musculoskeletal effects of an electrical stimulation induced cycling programme in the spinal injured. Paraplegia. 1994 Jun;32(6):407-15. doi: 10.1038/sc.1994.67.</citation>
      <PMID>8090549</PMID>
    </reference>
    <reference>
      <citation>Mazzoleni S, Stampacchia G, Gerini A, Tombini T, Carrozza MC. FES-cycling training in spinal cord injured patients. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:5339-41. doi: 10.1109/EMBC.2013.6610755.</citation>
      <PMID>24110942</PMID>
    </reference>
    <reference>
      <citation>Waters RL, Adkins RH, Yakura JS, Sie I. Motor and sensory recovery following incomplete paraplegia. Arch Phys Med Rehabil. 1994 Jan;75(1):67-72.</citation>
      <PMID>8291966</PMID>
    </reference>
    <reference>
      <citation>Wang RY, Wang FY, Huang SF, Yang YR. High-frequency repetitive transcranial magnetic stimulation enhanced treadmill training effects on gait performance in individuals with chronic stroke: A double-blinded randomized controlled pilot trial. Gait Posture. 2019 Feb;68:382-387. doi: 10.1016/j.gaitpost.2018.12.023. Epub 2018 Dec 18.</citation>
      <PMID>30586670</PMID>
    </reference>
    <reference>
      <citation>Shariat A, Najafabadi MG, Ansari NN, Cleland JA, Singh MAF, Memari AH, Honarpishe R, Hakakzadeh A, Ghaffari MS, Naghdi S. The effects of cycling with and without functional electrical stimulation on lower limb dysfunction in patients post-stroke: A systematic review with meta-analysis. NeuroRehabilitation. 2019;44(3):389-412. doi: 10.3233/NRE-182671.</citation>
      <PMID>31227660</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>incomplete spinal cord injury</keyword>
    <keyword>repetitive transcranial magnetic stimulation</keyword>
    <keyword>functional electrical stimulation cycling</keyword>
    <keyword>lower extremity function</keyword>
    <keyword>walking speed</keyword>
    <keyword>muscle strength</keyword>
    <keyword>feasibility</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Cord Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>IPD of this study will not be shared with other researchers of other studies.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05975606
  org study id: 122650
  nct id: NCT05975606
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This project is randomized controlled trial which will explore the effect of pairing
        repetitive Transcranial Magnetic Stimulation (rTMS) with Functional Electrical Stimulation
        (FES) Cycling on lower extremity function in people with incomplete spinal cord injury and
        compare the effects to each one of these interventions alone.
  Following a spinal cord injury, people often have decreased strength and balance in their
        legs, making it difficult to walk. To improve leg function in people with spinal cold
        injuries, the investigators can use electrical stimulation on muscles while participants are
        cycling to increase the muscle activation and nerve connections. Another way to improve the
        nerve connections to the muscles is by stimulating the brain directly. Previous research has
        looked at the effects of each of these treatments, but they have not been used together. In
        this study, the investigators will pair both electrical stimulation on the legs during
        cycling with brain stimulation or a sham brain stimulation to improve recovery and determine
        if using these methods together results in better outcomes, such as increased walking speed.
        Participants will attend training sessions for six weeks, twice per week. Each person will
        first receive the active or sham brain stimulation at the beginning of the session for 30
        minutes and then they will receive the electrical stimulation on their legs while cycling for
        60 minutes. Participants will be evaluated before the start of the treatment, in the middle
        of the study, at the final session, and again two weeks after the last session of the
        treatment. Assessments will include clinical tests of gait, balance, and strength. Inertial
        Measurement Units (IMU) and a pressure sensor gait mat will be used to evaluate the gait and
        balance parameters.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This protocol involves two groups of participants: intervention group and control group. Intervention group will receive real rTMS and FES cycling and control group will receive sham rTMS and FES cycling. The results of these groups are then evaluated at several stages of the study.
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  masking description: Participants are blinded to their groups. Research assistant and physiotherapist who are responsible for conducting assessment sessions are also blinded to participants group.
  All the participants will be randomized to groups using opaque envelopes blocked by four and stratified by AIS score.
  measure: Time taken to complete the recruitment of 12 participants
  time frame: 8 weeks
  description: This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the feasibility of the protocol.
  measure: Proportion of participants recruited from the total number screened
  time frame: 8 weeks
  description: This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the feasibility of the protocol.
  measure: Number of sessions attended by each participant
  time frame: 8 weeks
  description: This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol.
  measure: Number of dropouts in each group
  time frame: 8 weeks
  description: This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol.
  measure: Willingness of participants to undergo therapy
  time frame: 8 weeks
  description: This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol. The willingness of participation will be collected on an 11-point numerical rating scale with 'not at all willing' at 0, and 'very willing' at 10 (measured at baseline).
  measure: Incidence of treatment-emergent adverse events
  time frame: 8 weeks
  description: This outcome will be evaluated through descriptive data. Safety will be presented as any adverse reaction reported on verbal questioning at each session. The number of participants reporting adverse reactions, and the duration and severity of the adverse reactions will be reported.
  measure: Walking speed
  time frame: 8 weeks
  description: This instrumental outcome is collected using a pressure sensor gait mat.
  measure: Step length
  time frame: 8 weeks
  description: This instrumental outcome is collected using a pressure sensor gait mat.
  measure: Step width
  time frame: 8 weeks
  description: This instrumental outcome is collected using a pressure sensor gait mat.
  measure: Cadence
  time frame: 8 weeks
  description: This instrumental outcome is collected using a pressure sensor gait mat.
  measure: Timed Up and Go (TUG) test
  time frame: 8 weeks
  description: This instrumental outcome will be collected using Inertial Measurement Units (IMUs).
  measure: Sit-to-stand test
  time frame: 8 weeks
  description: This instrumental outcome will be collected using Inertial Measurement Units (IMUs).
  measure: Postural sway test
  time frame: 8 weeks
  description: This instrumental outcome will be collected using Inertial Measurement Units (IMUs).
  measure: Lower Extremity Motor Score (LEMS)
  time frame: 8 weeks
  description: A blinded physiotherapist will be hired to collect this clinical outcome.
  Lower Extremity Motor Score is rated from 0 to 5* as follows:
  0= Total paralysis
  Palpable or visible contraction
  Active movement, full range of motion (ROM) when gravity is eliminated
  Active movement, full ROM against gravity
  Active movement, full ROM against gravity, and moderate resistance in muscle-specific position
  (Normal) Active movement, full ROM against gravity, and full resistance in a muscle-specific position expected from a healthy person 5*= (Normal) Active movement, full ROM against gravity, and sufficient resistance to be considered normal if identified inhibiting factors (i.e., pain, disuse) were not present NT = Not testable (i.e., due to immobilization, sever pain that can prevent the grading of the patient, amputation of the limb, or contracture of >50% of the range of motion) Higher scores in this outcome mean better result.
  measure: Walking Index for Spinal Cord Injury (WISCI) II scale
  time frame: 8 weeks
  description: A blinded physiotherapist will be hired to collect this clinical outcome. Walking Index for Spinal Cord Injury version II scale is rated from 0 to 20 with the higher scores showing better results.
  measure: Global Rating of Change (GRC) scale
  time frame: 8 weeks
  description: Evaluation of the participants' impact will be collected through a GRC questionnaire in each assessment session.
  Global Rating Scale will ask participants to rate their walking abilities and overall recovery of the lower limb function from the time that they began the treatment until now. This scale is rated from -7 to 7 as follows:
  7: A very great deal worse
  6: A great deal worse
  5: Quite a bit worse
  4: Moderately worse
  3: Somewhat worse
  2: A little bit worse
  1: A tiny bit worse (almost the same) 0: About the same
  1: A tiny bit better (almost the same)
  2: A little bit better
  3: Somewhat better
  4: Moderately better
  5: Quite a bit better
  6: A great deal better
  7: A very great deal better
  Higher scores in this outcome mean better results.
  arm group label: Treatment group
  arm group type: Experimental
  description: Participants of this group will receive active rTMS along with real FES cycling.
  arm group label: Control group
  arm group type: Sham Comparator
  description: Participants of this group will receive sham rTMS along with real FES cycling.
  intervention type: Device
  intervention name: repetitive transcranial magnetic stimulation (rTMS)
  description: rTMS will be applied to primary motor cortex of the brain.
  arm group label: Treatment group
  intervention type: Device
  intervention name: functional electrical stimulation (FES) cycling
  description: FES will be applied to muscles associated in cycling: quadriceps, hamstrings, tibialis anterior, gastrocnemius, soleus.
  arm group label: Control group
  arm group label: Treatment group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Siobhan Schabrun, PhD
  role: Study Director
  affiliation: Western University, Canada
  last name: Janelle Unger, PhD
  phone: +1-519 664-6100
  phone ext: 45789
  email: janelle.unger@uwo.ca
  last name: Fereshteh Ghahremani, BSc
  phone: +1-647-622-4303
  email: fghahrem@uwo.ca
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: Canada
  citation: Ding W, Hu S, Wang P, Kang H, Peng R, Dong Y, Li F. Spinal Cord Injury: The Global Incidence, Prevalence, and Disability From the Global Burden of Disease Study 2019. Spine (Phila Pa 1976). 2022 Nov 1;47(21):1532-1540. doi: 10.1097/BRS.0000000000004417. Epub 2022 Jun 30.
  PMID: 35857624
  citation: Qin W, Bauman WA, Cardozo C. Bone and muscle loss after spinal cord injury: organ interactions. Ann N Y Acad Sci. 2010 Nov;1211:66-84. doi: 10.1111/j.1749-6632.2010.05806.x.
  PMID: 21062296
  citation: REED WB, PIDGEON J, BECKER SW. Patients with spinal cord injury. Clinical cutaneous studies. Arch Dermatol. 1961 Mar;83:379-85. doi: 10.1001/archderm.1961.01580090029002. No abstract available.
  PMID: 13740272
  citation: Riggins MS, Kankipati P, Oyster ML, Cooper RA, Boninger ML. The relationship between quality of life and change in mobility 1 year postinjury in individuals with spinal cord injury. Arch Phys Med Rehabil. 2011 Jul;92(7):1027-33. doi: 10.1016/j.apmr.2011.02.010.
  PMID: 21704781
  citation: Sadowsky CL, Hammond ER, Strohl AB, Commean PK, Eby SA, Damiano DL, Wingert JR, Bae KT, McDonald JW 3rd. Lower extremity functional electrical stimulation cycling promotes physical and functional recovery in chronic spinal cord injury. J Spinal Cord Med. 2013 Nov;36(6):623-31. doi: 10.1179/2045772313Y.0000000101. Epub 2013 Mar 20.
  PMID: 24094120
  citation: BARRIA P, AGUILAR R, DS D, MORIS A, ANDRADE A, JM A. Instrumented gait analysis of stroke patients after FES-cycling therapy.
  citation: Benito J, Kumru H, Murillo N, Costa U, Medina J, Tormos JM, Pascual-Leone A, Vidal J. Motor and gait improvement in patients with incomplete spinal cord injury induced by high-frequency repetitive transcranial magnetic stimulation. Top Spinal Cord Inj Rehabil. 2012 Spring;18(2):106-12. doi: 10.1310/sci1802-106.
  PMID: 23459246
  citation: Fawaz S, Kamel F, El Yasaky A, El Shishtawy H, Genedy A, Awad RM, El Nabil L. The therapeutic application of functional electrical stimulation and transcranial magnetic stimulation in rehabilitation of the hand function in incomplete cervical spinal cord injury. Egyptian Rheumatology and Rehabilitation. 2019 Jan;46(1):21-6.
  citation: Shariat A, Hosseini L, Najafabadi MG, Cleland JA, Shaw BS, Shaw I. Functional Electrical Stimulation and Repetitive Transcranial Magnetic Stimulation for Neurorehabilitation in Patients Post Stroke: A Short Communication. Asian Journal of Sports Medicine. 2018 Dec 31;9(4).
  citation: Krogh S, Aagaard P, Jonsson AB, Figlewski K, Kasch H. Effects of repetitive transcranial magnetic stimulation on recovery in lower limb muscle strength and gait function following spinal cord injury: a randomized controlled trial. Spinal Cord. 2022 Feb;60(2):135-141. doi: 10.1038/s41393-021-00703-8. Epub 2021 Sep 9.
  PMID: 34504284
  citation: Alexeeva N, Calancie B. Efficacy of QuadroPulse rTMS for improving motor function after spinal cord injury: Three case studies. J Spinal Cord Med. 2016;39(1):50-7. doi: 10.1179/2045772314Y.0000000279. Epub 2014 Dec 1.
  PMID: 25437531
  citation: Kumru H, Benito J, Murillo N, Valls-Sole J, Valles M, Lopez-Blazquez R, Costa U, Tormos JM, Pascual-Leone A, Vidal J. Effects of high-frequency repetitive transcranial magnetic stimulation on motor and gait improvement in incomplete spinal cord injury patients. Neurorehabil Neural Repair. 2013 Jun;27(5):421-9. doi: 10.1177/1545968312471901. Epub 2013 Jan 15.
  PMID: 23322551
  citation: Kumru H, Benito-Penalva J, Valls-Sole J, Murillo N, Tormos JM, Flores C, Vidal J. Placebo-controlled study of rTMS combined with Lokomat(R) gait training for treatment in subjects with motor incomplete spinal cord injury. Exp Brain Res. 2016 Dec;234(12):3447-3455. doi: 10.1007/s00221-016-4739-9. Epub 2016 Jul 28.
  PMID: 27469242
  citation: Donaldson N, Perkins TA, Fitzwater R, Wood DE, Middleton F. FES cycling may promote recovery of leg function after incomplete spinal cord injury. Spinal Cord. 2000 Nov;38(11):680-2. doi: 10.1038/sj.sc.3101072.
  PMID: 11114775
  citation: Sloan KE, Bremner LA, Byrne J, Day RE, Scull ER. Musculoskeletal effects of an electrical stimulation induced cycling programme in the spinal injured. Paraplegia. 1994 Jun;32(6):407-15. doi: 10.1038/sc.1994.67.
  PMID: 8090549
  citation: Mazzoleni S, Stampacchia G, Gerini A, Tombini T, Carrozza MC. FES-cycling training in spinal cord injured patients. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:5339-41. doi: 10.1109/EMBC.2013.6610755.
  PMID: 24110942
  citation: Waters RL, Adkins RH, Yakura JS, Sie I. Motor and sensory recovery following incomplete paraplegia. Arch Phys Med Rehabil. 1994 Jan;75(1):67-72.
  PMID: 8291966
  citation: Wang RY, Wang FY, Huang SF, Yang YR. High-frequency repetitive transcranial magnetic stimulation enhanced treadmill training effects on gait performance in individuals with chronic stroke: A double-blinded randomized controlled pilot trial. Gait Posture. 2019 Feb;68:382-387. doi: 10.1016/j.gaitpost.2018.12.023. Epub 2018 Dec 18.
  PMID: 30586670
  citation: Shariat A, Najafabadi MG, Ansari NN, Cleland JA, Singh MAF, Memari AH, Honarpishe R, Hakakzadeh A, Ghaffari MS, Naghdi S. The effects of cycling with and without functional electrical stimulation on lower limb dysfunction in patients post-stroke: A systematic review with meta-analysis. NeuroRehabilitation. 2019;44(3):389-412. doi: 10.3233/NRE-182671.
  PMID: 31227660
  responsible party type: Sponsor
  mesh term: Spinal Cord Injuries
  sharing ipd: No
  ipd description: IPD of this study will not be shared with other researchers of other studies.