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The Effect of tDCS Combined With Functional Task Training on Motor Recovery in Stroke Patients

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ClinicalTrials.gov Identifier: NCT04646577
Recruitment Status : Not yet recruiting
First Posted : November 30, 2020
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
King Fahad Specialist Hospital Dammam

Study Description
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Brief Summary:
We propose to enhance the effects of brain plasticity using a powerful noninvasive technique for brain modulation consisting of navigated transcranial magnetic stimulation (TMS) priming with transcranial direct current stimulation (tDCS) in combination with motor-training-like constraint-induced movement therapy (CIMT).

Condition or disease Intervention/treatment Phase
Stroke Stroke, Acute Motor Function Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Device: Transcranial Direct Current Stimulation (tDCS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Transcranial Direct Current Stimulation Combined With Functional Task Training on Motor Recovery in Stroke Patients
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 30, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Subjects will either undergo (1) active low-frequency rTMS (1Hz continuous) prime with anodal Transcranial Direct Current Stimulation (tDCS) on the affected side combine with Constraint induced movement therapy. Each session will last 20 minutes.

Device: Transcranial Direct Current Stimulation (tDCS
Subjects will either undergo sham Transcranial Direct Current Stimulation (tDCS) on the affected side combine with Constraint-induced movement therapy.
Sham Comparator: Sham Device: Transcranial Direct Current Stimulation (tDCS
Subjects will either undergo sham Transcranial Direct Current Stimulation (tDCS) on the affected side combine with Constraint-induced movement therapy.


Outcome Measures
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Primary Outcome Measures :
  1. To assess the neurophysiologic findings of cortical plasticity. [ Time Frame: Before 10 sessions, before and after each session (every day), after 10 daily sessions and after 6 weeks ]
    Expressed as percent motor resting threshold and numerical values of motor evoked potential. The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% of motor resting threshould). The percentage of inhibition or facilitation for each before and after stimulation will be calculated.

  2. To assess the motor function changes . [ Time Frame: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days ]
    Change from motor hand function: ordinal variable measured through the Jebsen-Taylor Hand Function Test (JTHFT). The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, simulated feeding, stacking, and lifting large, lightweight, and heavy objects


Secondary Outcome Measures :
  1. Sensory-motor function of the upper limb [ Time Frame: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days ]
    This consists of a quantitative scale developed to measure (motor recovery, balance, sensation, and some joint function) recovery of the motor function of stroke patients. Measured through the Fugl-Meyer Rating Scale, which expressed in values from 0 to 66.

  2. Degree of disability: [ Time Frame: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days ]
    This consists of a quantitative scale developed to measured the disability caused by impairments in stroke patients. The Barthel Index Score (Activities of Daily Living) measured through ranges from 0 to 20, principally concerned with physical aspects of disability.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 18-90
  2. first-time clinical ischemic or hemorrhagic cerebrovascular accident as noted in the radiological (or physician's) report;
  3. the ability to extend =20° at the wrist and 10° at the metacarpophalangeal and interphalangeal joints of all digits;
  4. participants must demonstrate adequate balance while wearing the restraint;
  5. the ability to stand from a sitting position and the ability to stand for at least 2 minutes with or without upper extremity support;
  6. weakness, defined as score of 15-55 (out of 66) on arm motor Fugl-Meyer (FM) scale; and
  7. stroke onset more then 6 months prior to study enrollment.

Exclusion Criteria:

  1. significant pre-stroke disability;
  2. where applicable (a history of depression before the stroke);
  3. any substantial decrease in alertness, language reception, or attention that might interfere with understanding the instructions for the motor testing;
  4. excessive pain in any joint of the paretic extremity;
  5. contraindications to single-pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants;
  6. advanced liver, kidney, cardiac, or pulmonary disease;
  7. a terminal medical diagnosis consistent with survival 1 year;
  8. coexistent major neurological or psychiatric disease (to decrease the number of confounders);
  9. a history of significant drug abuse in the prior 6 months;
  10. the use of certain neuropsychotropic drugs such as tricyclics, antidepressants, or 51 of 66 carbamazepine;
  11. active enrollment in a separate intervention study targeting stroke recovery; (
  12. previously applied constraint-induced motor therapy and/or tDCS treatment for stroke; and
  13. a history of epilepsy before stroke (or episodes of seizures within the last six months).
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: King Fahad Specialist Hospital Dammam
ClinicalTrials.gov Identifier: NCT04646577    
Other Study ID Numbers: NEU0329
First Posted: November 30, 2020    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases