<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/NCT02250690</url>
  </required_header>
  <id_info>
    <org_study_id>Parkinson_tDCS_Gait_Impairment</org_study_id>
    <nct_id>NCT02250690</nct_id>
  </id_info>
  <brief_title>Neuromodulation on Motor Function in Parkinson's Disease</brief_title>
  <official_title>Transcranial Direct Current Stimulation (tDCS) Associated With Gait Training in Improving Motor Function in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal de Pernambuco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal de Pernambuco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of the present study was to analyze the effect of consecutive sessions of&#xD;
      Transcranial direct current stimulation associated to kinesiotherapy about gait performance&#xD;
      of Parkinson' s disease. For this, the primary outcome was evaluation of gait performance by&#xD;
      means of space and temporal parameters as speed (meter/second ), stride frequency (steps/min)&#xD;
      and stride length (m). The secondary outcome is motor cortex excitability which is analyzed&#xD;
      by means of single pulse transcranial magnetic stimulation (TMS) intends to determine: motor&#xD;
      evoked potential amplitude (MEP) and rest motor threshold (rMT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consist by interventions involving screening followed by evaluation, where&#xD;
      volunteers were subjected to the many tests: history, session III of the Unified Scale&#xD;
      Modified Parkinson's Disease - Unified Parkinson 's Disease Rating Scale, Ten meters walk&#xD;
      test - Walk Test 10 meters and shoot gait, (using Studio Version 8 software). On the same&#xD;
      day, the subjects underwent assessment of brain excitability to determine motor threshold and&#xD;
      amplitude of the motor evoked potential (MEP). The randomization of the volunteers was&#xD;
      conducted by an external search through opaque envelopes ordered according to a random&#xD;
      distribution. The subjects were divided into two groups : control group , this group&#xD;
      submitted to Transcranial Stimulation sessions a sham Continuous Current (sham tDCS) and gait&#xD;
      training , and Experimental group, subjected to the stimulation by Transcranial Direct&#xD;
      Current sessions (active tDCS ) and gait training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2013</start_date>
  <completion_date type="Anticipated">November 2014</completion_date>
  <primary_completion_date type="Anticipated">October 2014</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change on Bradykinesia</measure>
    <time_frame>This outcome will be measure before and after each session, before ten sessions, 1 and 2 months after ten session</time_frame>
    <description>This outcome will be measure in three different moments of evaluation and at all interventions (sessions) days - before and after intervention. Beyond these evaluations, the voluntairs will be evaluate at: T1- before ten sessions; T2- Immediately after ten sessions and T3- after a period of 1 month without intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change on Cortical excitability</measure>
    <time_frame>The evaluation occur in 3 different moments: before and after each session, after a period of 1 month without intervention. This outcome will be measure at all intervention and evaluation days</time_frame>
    <description>The secondary outcome measures will be done using amplitude of Motor Evoked Potential (MEP) and rest Motor Threshold (rMT) elicited by transcranial magnetic stimulation (TMS) by means of Neuro-MS device of Neurosoft.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change on Balance</measure>
    <time_frame>This outcome will be measure before ten sessions, 1 and 2 months after ten session</time_frame>
    <description>Berg Balance scale (BBS) is measured asking to the patient for change posture in sit position for search balance during transferences and standing with one foot at single or double support, with open and closed eyes, narrow support base body, rotation around the own body axis; take up an object at floor and others. This outcome is done using a scale with scores range from 0 to 56.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Idiopathic Parkinsons Disease</condition>
  <arm_group>
    <arm_group_label>experimental group - tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The tDCS intervention occur at 10 sessions of intervention where electrodes are connected to head specifically in supplementary motor area placed at 2 cm in front of vertex. The clinical stimulator (NeuroConn, Germany) provided the direct current using two silicon-sponge electrodes with a surface area of 35 cm2 (5 × 7cm) embedded in a saline-soaked solution. Immediately after 13 minutes of tDCS application, patient was submitted to gait training three times a week during 4 weeks with visuals cues. The patients were asked to walk along at a 7 meters rubber carpet to at different speed, forward and backward gait, side walk during thirty minutes with three intervals of two minutes. The patient may be at on state of drug administration and the training is applied by another physiotherapist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group (tDCS sham)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The sham character is ensured by the stimulation time, once the device is programmed to turn off 30 seconds after the beginning of stimulation. The current is switched in ascending ramp mode for 10 seconds until 2 mili ampere and a descending ramp similar also for 10 seconds will be used until the end of stimulation. The sham stimulation is commonly perceived by the patient as the actual treatment and all procedures for the application of the technique should be similar to those adopted for the active stimulation. Immediately after tDCS stimulation, the gait training consisting of a protocol based on sensory cues for 30 minutes is administered three times a week for four weeks. Sham stimulation will be held for 30 seconds in order to mimic the perceived lowering effect of ramp current.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>experimental group - tDCS</intervention_name>
    <arm_group_label>experimental group - tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control group (tDCS sham)</intervention_name>
    <arm_group_label>Control group (tDCS sham)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Main eligibility criteria were idiopathic Parkinson's disease&#xD;
&#xD;
          -  Both sex&#xD;
&#xD;
          -  Hoehn and Yahr stage I to III&#xD;
&#xD;
          -  Showing mild to severe gait disturbances&#xD;
&#xD;
          -  Stable medication usage&#xD;
&#xD;
          -  Age 40 to 80 years&#xD;
&#xD;
          -  And absence of cognitive impairment and disorders interfering with participation in&#xD;
             cueing therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of chronic disabling pathologies of lower limb&#xD;
&#xD;
          -  Presence of pacemaker or severe cardiovascular conditions&#xD;
&#xD;
          -  A history of tumor, prior neurosurgical brain&#xD;
&#xD;
          -  Intervention, or severe cardiovascular conditions, including the presence of a&#xD;
             pacemaker&#xD;
&#xD;
          -  A diagnosis of epilepsy or major psychiatric disorders.&#xD;
&#xD;
          -  Participants with other neurological, muscular, or psychiatric disorders (e.g.&#xD;
             peripheral neuropathies, uncorrected visual problems, hearing problems, vestibular&#xD;
             dysfunction, stroke, seizure, migraine, or frequent severe headaches) were excluded.&#xD;
&#xD;
          -  Participants with surgical implants, significant postural tremor, dyskinesia, severe&#xD;
             freezing or dementia were also excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>March 31, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 24, 2014</last_update_submitted>
  <last_update_submitted_qc>September 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Pernambuco</investigator_affiliation>
    <investigator_full_name>Adriana Carla Costa Ribeiro Clementino</investigator_full_name>
    <investigator_title>Transcranial direct current stimulation (tDCS) associated with gait training in improving motor function in Parkinson's disease.</investigator_title>
  </responsible_party>
  <keyword>idiopathic PD</keyword>
  <keyword>Hoehn and Yahr stage I to III</keyword>
  <keyword>stable medication usage</keyword>
  <keyword>age 40 to 80 years</keyword>
  <keyword>absence of cognitive impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT02250690
org study id: Parkinson_tDCS_Gait_Impairment
nct id: NCT02250690
lead sponsor: 
has dmc: Yes
The aims of the present study was to analyze the effect of consecutive sessions of
      Transcranial direct current stimulation associated to kinesiotherapy about gait performance
      of Parkinson' s disease. For this, the primary outcome was evaluation of gait performance by
      means of space and temporal parameters as speed (meter/second ), stride frequency (steps/min)
      and stride length (m). The secondary outcome is motor cortex excitability which is analyzed
      by means of single pulse transcranial magnetic stimulation (TMS) intends to determine: motor
      evoked potential amplitude (MEP) and rest motor threshold (rMT).
This study consist by interventions involving screening followed by evaluation, where
      volunteers were subjected to the many tests: history, session III of the Unified Scale
      Modified Parkinson's Disease - Unified Parkinson 's Disease Rating Scale, Ten meters walk
      test - Walk Test 10 meters and shoot gait, (using Studio Version 8 software). On the same
      day, the subjects underwent assessment of brain excitability to determine motor threshold and
      amplitude of the motor evoked potential (MEP). The randomization of the volunteers was
      conducted by an external search through opaque envelopes ordered according to a random
      distribution. The subjects were divided into two groups : control group , this group
      submitted to Transcranial Stimulation sessions a sham Continuous Current (sham tDCS) and gait
      training , and Experimental group, subjected to the stimulation by Transcranial Direct
      Current sessions (active tDCS ) and gait training.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change on Bradykinesia
time frame: This outcome will be measure before and after each session, before ten sessions, 1 and 2 months after ten session
description: This outcome will be measure in three different moments of evaluation and at all interventions (sessions) days - before and after intervention. Beyond these evaluations, the voluntairs will be evaluate at: T1- before ten sessions; T2- Immediately after ten sessions and T3- after a period of 1 month without intervention.
measure: Change on Cortical excitability
time frame: The evaluation occur in 3 different moments: before and after each session, after a period of 1 month without intervention. This outcome will be measure at all intervention and evaluation days
description: The secondary outcome measures will be done using amplitude of Motor Evoked Potential (MEP) and rest Motor Threshold (rMT) elicited by transcranial magnetic stimulation (TMS) by means of Neuro-MS device of Neurosoft.
measure: Change on Balance
time frame: This outcome will be measure before ten sessions, 1 and 2 months after ten session
description: Berg Balance scale (BBS) is measured asking to the patient for change posture in sit position for search balance during transferences and standing with one foot at single or double support, with open and closed eyes, narrow support base body, rotation around the own body axis; take up an object at floor and others. This outcome is done using a scale with scores range from 0 to 56.
arm group label: experimental group - tDCS
arm group type: Experimental
description: The tDCS intervention occur at 10 sessions of intervention where electrodes are connected to head specifically in supplementary motor area placed at 2 cm in front of vertex. The clinical stimulator (NeuroConn, Germany) provided the direct current using two silicon-sponge electrodes with a surface area of 35 cm2 (5 × 7cm) embedded in a saline-soaked solution. Immediately after 13 minutes of tDCS application, patient was submitted to gait training three times a week during 4 weeks with visuals cues. The patients were asked to walk along at a 7 meters rubber carpet to at different speed, forward and backward gait, side walk during thirty minutes with three intervals of two minutes. The patient may be at on state of drug administration and the training is applied by another physiotherapist.
arm group label: Control group (tDCS sham)
arm group type: Sham Comparator
description: The sham character is ensured by the stimulation time, once the device is programmed to turn off 30 seconds after the beginning of stimulation. The current is switched in ascending ramp mode for 10 seconds until 2 mili ampere and a descending ramp similar also for 10 seconds will be used until the end of stimulation. The sham stimulation is commonly perceived by the patient as the actual treatment and all procedures for the application of the technique should be similar to those adopted for the active stimulation. Immediately after tDCS stimulation, the gait training consisting of a protocol based on sensory cues for 30 minutes is administered three times a week for four weeks. Sham stimulation will be held for 30 seconds in order to mimic the perceived lowering effect of ramp current.
intervention type: Device
intervention name: experimental group - tDCS
arm group label: experimental group - tDCS
intervention type: Device
intervention name: Control group (tDCS sham)
arm group label: Control group (tDCS sham)
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal de Pernambuco
investigator full name: Adriana Carla Costa Ribeiro Clementino
investigator title: Transcranial direct current stimulation (tDCS) associated with gait training in improving motor function in Parkinson's disease.
mesh term: Parkinson Disease