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

The Effect of Transcranial Direct Current Stimulation Combined With Functional Task Training on Motor Recovery in Stroke Patients

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).

Study Overview

• Status: Unknown
• Conditions: Stroke; Stroke, Acute; Motor Function
• Intervention / Treatment: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Transcranial Direct Current Stimulation (tDCS

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the neurophysiologic findings of cortical plasticity.	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.	Before 10 sessions, before and after each session (every day), after 10 daily sessions and after 6 weeks
To assess the motor function changes .	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	before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory-motor function of the upper limb	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.	before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
Degree of disability:	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.	before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days

Collaborators and Investigators

• Sponsor: King Fahad Specialist Hospital Dammam

Publications and helpful links

General Publications

• Al-Hussain F, Nasim E, Iqbal M, Altwaijri N, Asim N, Yoo WK, Bashir S. The effect of transcranial direct current stimulation combined with functional task training on motor recovery in stroke patients. Medicine (Baltimore). 2021 Feb 12;100(6):e24718. doi: 10.1097/MD.0000000000024718.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2020
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): May 30, 2022

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: November 22, 2020
• First Posted (ACTUAL): November 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 22, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: NEU0329

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No