<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/NCT03792789</url>
  </required_header>
  <id_info>
    <org_study_id>IECPG/574/11/2018</org_study_id>
    <nct_id>NCT03792789</nct_id>
  </id_info>
  <brief_title>Evaluation of Repetitive Transcranial Magnetic Stimulation as an Adjunct to Modified Constraint Induced Movement Therapy in Improving Upper Limb Function in Children With Hemiparetic Cerebral Palsy Aged 5 - 18 Years</brief_title>
  <official_title>Evaluation of Repetitive Transcranial Magnetic Stimulation as an Adjunct to Modified Constraint Induced Movement Therapy in Improving Upper Limb Function in Children With Hemiparetic Cerebral Palsy Aged 5 - 18 Years - A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>All India Institute of Medical Sciences, New Delhi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>All India Institute of Medical Sciences, New Delhi</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>
      The investigators aim to evaluate efficacy of TMS as an adjunct to CIMT, assess its safety&#xD;
      and tolerability and study cortical excitability with help of TMS which are both&#xD;
      rehabilitative therapies for hemiplegic cerebral palsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cerebral palsy is the most common motor disability of childhood and Hemiparetic cerebral&#xD;
      palsy accounts for about one third of cases. Improving spasticity and upper limb function in&#xD;
      these children can lead to better functional outcome and quality of life. TMS is an upcoming&#xD;
      rehabilitative modality which has shown promising results in western studies. It has benefits&#xD;
      of being non-invasive and has shown to have additive effect when used with CIMT which is&#xD;
      standard of care in hemiparetic CP. However, randomized controlled clinical trials comparing&#xD;
      it with CIMT alone in hemiparetic CP are very few, none from India so far. The dose, type and&#xD;
      duration of TMS and its feasibility in resource limited set up needs to be investigated in&#xD;
      children .Therefore, the investigators aim to evaluate efficacy of TMS as an adjunct to CIMT,&#xD;
      assess its safety and tolerability and study cortical excitability with help of TMS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 15, 2019</start_date>
  <completion_date type="Anticipated">August 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of 4 weeks of mCIMT with sham/real rTMS</measure>
    <time_frame>Within 1 week of end of 4 weeks of mCIMT with sham/real rTMS</time_frame>
    <description>◦ To evaluate the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as an adjunct to modified Constraint Induced Movement Therapy (mCIMT) for 4 weeks in improving the Upper Limb Function as per increase in total QUEST score by 5 in 5-18 years old children with Hemiparetic Cerebral Palsy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate improvement in dissociated movements, grasp, weight bearing and protective extension in each group at the end of 4 weeks</measure>
    <time_frame>within 1 week of end of 4 weeks of mCIMT with sham/real rTMS</time_frame>
    <description>To evaluate improvement in dissociated movements, grasp, weight bearing and protective extension in each group at the end of 4 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate improvement in speed of upper limb movements in each group at the end of 4 weeks</measure>
    <time_frame>within 1 week of end of 4 weeks of mCIMT with sham/real rTMS</time_frame>
    <description>To evaluate improvement in speed of upper limb movements in each group at the end of 4 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate improvement in muscle strength in each group at the end of 4 weeks</measure>
    <time_frame>within 1 week of end of 4 weeks of mCIMT with sham/real rTMS</time_frame>
    <description>To evaluate improvement in muscle strength in each group at the end of 4 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess improvement in quality of life after the intervention in each group</measure>
    <time_frame>within 1 week of end of 4 weeks of mCIMT with sham/real rTMS</time_frame>
    <description>To assess improvement in quality of life after the intervention in each group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess compliance to therapy in each group by Daily Compliance Log</measure>
    <time_frame>within 1 week of end of 4 weeks of mCIMT with sham/real rTMS</time_frame>
    <description>To assess compliance to therapy in each group by Daily Compliance Log</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To study for adverse events of TMS</measure>
    <time_frame>within 1 week of end of 4 weeks of mCIMT with sham/real rTMS</time_frame>
    <description>To study for adverse events of TMS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate cortical excitability with TMS at baseline and the end of 4 weeks</measure>
    <time_frame>within 1 week of end of 4 weeks of mCIMT with sham/real rTMS</time_frame>
    <description>To evaluate cortical excitability with TMS at baseline and the end of 4 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• To evaluate sustenance of improvement by change in QUEST score at the end of 12 weeks, 8 weeks after stopping supervised treatment in both the groups</measure>
    <time_frame>within 1 week of end of 4 weeks of mCIMT with sham/real rTMS</time_frame>
    <description>• To evaluate sustenance of improvement by change in QUEST score at the end of 12 weeks, 8 weeks after stopping supervised treatment in both the groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Hemiparetic Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>mCIMT with real rTMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Modified Constraint Induced Movement Therapy (mCIMT) with real Repetitive Transcranial Magnetic Stimulation (rTMS). 10 sessions of mCIMT will be administered using physical rehabilitation protocol along with real rTMS over contralateral primary motor cortex.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mCIMT with sham rTMS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Modified Constraint Induced Movement Therapy with sham Repetitive Transcranial Magnetic Stimulation (using sham coil). 10 sessions of mCIMT will be administered using physical rehabilitation protocol along with sham rTMS over contralateral primary motor cortex using sham coil which simulated sound and touch of real coil but has no electro-magnetic waves.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>mCIMT with real rTMS</intervention_name>
    <description>Modified constraint induced movement therapy will be provided to all children according to predefined protocol.&#xD;
rTMS will be provided using figure of eight shaped coil and TMS stimulator ((Magventure Denmark, X100 with mapoption) over contra-lesional primary motor cortex over 10 sessions of 20 minutes each spread over 4 weeks. Each session will comprise priming ( 10 minutes of 6Hz rTMS at 90% of resting motor threshold, delivered in two trains per minute with 5 seconds per train and 25-seconds intervals between trains (a total of 600 priming pulses)). Priming will be followed immediately by additional 10 minutes of 1Hz rTMS at 90% of resting motor threshold without interruption (a total of 600 low-frequency pulses).</description>
    <arm_group_label>mCIMT with real rTMS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>mCIMT with sham rTMS</intervention_name>
    <description>Modified constraint induced movement therapy will be provided to all children according to predefined protocol.&#xD;
Sham rTMS will be given using a sham coil.</description>
    <arm_group_label>mCIMT with sham rTMS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Age 5 - 18 years&#xD;
&#xD;
               -  Hemiparetic Cerebral Palsy (perinatal brain injury)&#xD;
&#xD;
               -  Intelligence Quotient &gt;70 (Binet Kamat Test/Malin's Intelligence Scale for&#xD;
                  Children)&#xD;
&#xD;
               -  Modified Ashworth scoring 1-3 for affected limb&#xD;
&#xD;
               -  Can sit independently or with support (GMFCS stage : 1-4 and Manual Ability&#xD;
                  Classification System stage: 1-3)&#xD;
&#xD;
               -  Preserved vision and hearing (with or without correction)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Uncontrolled epilepsy as defined by seizure frequency &gt;1/month for preceding 3&#xD;
             months&#xD;
&#xD;
               -  Severe concurrent illness or disease not associated with CP or unstable medical&#xD;
                  conditions like pneumonia&#xD;
&#xD;
               -  Genetic or syndromic associations&#xD;
&#xD;
               -  Children diagnosed with Autistic Spectrum Disorders&#xD;
&#xD;
               -  Modified Ashworth Scale Score more than 3 at shoulder/elbow/wrist&#xD;
&#xD;
               -  Contractures of affected limb&#xD;
&#xD;
               -  Severe movement disorder like dystonia, choreo-athetosis or ballismus interfering&#xD;
                  with purposeful limb movement&#xD;
&#xD;
               -  Any congenital brain malformation detected on conventional MRI brain&#xD;
&#xD;
               -  Recent surgery/cast/splint in affected limb&#xD;
&#xD;
               -  Botulinum toxin/phenol block in affected limb in past 6 months or planned to&#xD;
                  receive in study period&#xD;
&#xD;
               -  Those receiving tone modifying agents within two weeks before enrolment&#xD;
                  (Tizanidine, baclofen, benzodiazepines, dantrolene)&#xD;
&#xD;
               -  mCIMT received in last 6 months&#xD;
&#xD;
               -  Any contraindications for TMS - implanted electronic device and non-removable&#xD;
                  metallic objects near coil e.g. Pacemaker, cochlear implant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheffali Gulati, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>All India Institute of Medical Sciences, New Delhi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sheffali Gulati, MD</last_name>
    <phone>09810386847</phone>
    <email>sheffaligulati@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Juhi Gupta, MD</last_name>
    <phone>9999630637</phone>
    <email>juhiguptadr@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>India</name>
      <address>
        <city>New Delhi</city>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
    <contact>
      <last_name>Sheffali Gulati, MD</last_name>
      <phone>011-26594679</phone>
      <email>sheffaligulati@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>All India Institute of Medical Sciences, New Delhi</investigator_affiliation>
    <investigator_full_name>Sheffali Gulati</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Transcranial Magnetic Stimulation (TMS)</keyword>
  <keyword>modified Constraint Induced Movement Therapy (mCIMT)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03792789
org study id: IECPG/574/11/2018
nct id: NCT03792789
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators aim to evaluate efficacy of TMS as an adjunct to CIMT, assess its safety
      and tolerability and study cortical excitability with help of TMS which are both
      rehabilitative therapies for hemiplegic cerebral palsy.
Cerebral palsy is the most common motor disability of childhood and Hemiparetic cerebral
      palsy accounts for about one third of cases. Improving spasticity and upper limb function in
      these children can lead to better functional outcome and quality of life. TMS is an upcoming
      rehabilitative modality which has shown promising results in western studies. It has benefits
      of being non-invasive and has shown to have additive effect when used with CIMT which is
      standard of care in hemiparetic CP. However, randomized controlled clinical trials comparing
      it with CIMT alone in hemiparetic CP are very few, none from India so far. The dose, type and
      duration of TMS and its feasibility in resource limited set up needs to be investigated in
      children .Therefore, the investigators aim to evaluate efficacy of TMS as an adjunct to CIMT,
      assess its safety and tolerability and study cortical excitability with help of TMS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Efficacy of 4 weeks of mCIMT with sham/real rTMS
time frame: Within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
description: ◦ To evaluate the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as an adjunct to modified Constraint Induced Movement Therapy (mCIMT) for 4 weeks in improving the Upper Limb Function as per increase in total QUEST score by 5 in 5-18 years old children with Hemiparetic Cerebral Palsy
measure: To evaluate improvement in dissociated movements, grasp, weight bearing and protective extension in each group at the end of 4 weeks
time frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
description: To evaluate improvement in dissociated movements, grasp, weight bearing and protective extension in each group at the end of 4 weeks
measure: To evaluate improvement in speed of upper limb movements in each group at the end of 4 weeks
time frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
description: To evaluate improvement in speed of upper limb movements in each group at the end of 4 weeks
measure: To evaluate improvement in muscle strength in each group at the end of 4 weeks
time frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
description: To evaluate improvement in muscle strength in each group at the end of 4 weeks
measure: To assess improvement in quality of life after the intervention in each group
time frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
description: To assess improvement in quality of life after the intervention in each group
measure: To assess compliance to therapy in each group by Daily Compliance Log
time frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
description: To assess compliance to therapy in each group by Daily Compliance Log
measure: To study for adverse events of TMS
time frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
description: To study for adverse events of TMS
measure: To evaluate cortical excitability with TMS at baseline and the end of 4 weeks
time frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
description: To evaluate cortical excitability with TMS at baseline and the end of 4 weeks
measure: • To evaluate sustenance of improvement by change in QUEST score at the end of 12 weeks, 8 weeks after stopping supervised treatment in both the groups
time frame: within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
description: • To evaluate sustenance of improvement by change in QUEST score at the end of 12 weeks, 8 weeks after stopping supervised treatment in both the groups
arm group label: mCIMT with real rTMS
arm group type: Experimental
description: Modified Constraint Induced Movement Therapy (mCIMT) with real Repetitive Transcranial Magnetic Stimulation (rTMS). 10 sessions of mCIMT will be administered using physical rehabilitation protocol along with real rTMS over contralateral primary motor cortex.
arm group label: mCIMT with sham rTMS
arm group type: Sham Comparator
description: Modified Constraint Induced Movement Therapy with sham Repetitive Transcranial Magnetic Stimulation (using sham coil). 10 sessions of mCIMT will be administered using physical rehabilitation protocol along with sham rTMS over contralateral primary motor cortex using sham coil which simulated sound and touch of real coil but has no electro-magnetic waves.
intervention type: Device
intervention name: mCIMT with real rTMS
description: Modified constraint induced movement therapy will be provided to all children according to predefined protocol.
rTMS will be provided using figure of eight shaped coil and TMS stimulator ((Magventure Denmark, X100 with mapoption) over contra-lesional primary motor cortex over 10 sessions of 20 minutes each spread over 4 weeks. Each session will comprise priming ( 10 minutes of 6Hz rTMS at 90% of resting motor threshold, delivered in two trains per minute with 5 seconds per train and 25-seconds intervals between trains (a total of 600 priming pulses)). Priming will be followed immediately by additional 10 minutes of 1Hz rTMS at 90% of resting motor threshold without interruption (a total of 600 low-frequency pulses).
arm group label: mCIMT with real rTMS
intervention type: Device
intervention name: mCIMT with sham rTMS
description: Modified constraint induced movement therapy will be provided to all children according to predefined protocol.
Sham rTMS will be given using a sham coil.
arm group label: mCIMT with sham rTMS
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: No
last name: Sheffali Gulati, MD
role: Principal Investigator
affiliation: All India Institute of Medical Sciences, New Delhi
last name: Sheffali Gulati, MD
phone: 09810386847
email: sheffaligulati@gmail.com
last name: Juhi Gupta, MD
phone: 9999630637
email: juhiguptadr@gmail.com
facility: 
contact: 
country: India
responsible party type: Principal Investigator
investigator affiliation: All India Institute of Medical Sciences, New Delhi
investigator full name: Sheffali Gulati
investigator title: Professor
mesh term: Cerebral Palsy
sharing ipd: Undecided