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

Not Applicable

• Conditions: Stroke, Acute; Motor Function; Stroke
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Transcranial Direct Current Stimulation (tDCS

• Registration Number: NCT04646577
• Lead Sponsor: King Fahad Specialist Hospital Dammam

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-06
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-22
• Last Update Submitted: 2020-11-22
• Study First Posted: 2020-11-30
• Last Update Posted: 2020-11-30
• Study Start: 2020-12-01
• Primary Completion: 2021-05-01
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active	Transcranial Direct Current Stimulation (tDCS	-
Active	Repetitive Transcranial Magnetic Stimulation (rTMS)	-
Sham	Transcranial Direct Current Stimulation (tDCS	-

Primary Outcome Measures

Name	Time	Method
To assess the neurophysiologic findings of cortical plasticity.	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.
To assess the motor function changes .	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

Name	Time	Method
Degree of disability:	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.
Sensory-motor function of the upper limb	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.