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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04646577
• Other study ID #: NEU0329
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: May 30, 2022

Study information

• Verified date: November 2020
• Source: King Fahad Specialist Hospital Dammam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 30, 2022
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Motor Function
• Stroke
• Stroke, Acute

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Fahad Specialist Hospital Dammam

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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