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

NCT ID: NCT04646577

Last Updated: 2020-11-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-05-30

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).

Conditions

Stroke; Stroke, Acute; Motor Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Active

Group Type: ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

Sham

Group Type: SHAM_COMPARATOR

Transcranial Direct Current Stimulation (tDCS

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Fahad Specialist Hospital Dammam

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 33578615 (View on PubMed)

Other Identifiers

NEU0329

Identifier Type: -

Identifier Source: org_study_id