Efficacy and Time Dependent Effects of tDCS Combined With MT for Rehabilitation After Subacute and Chronic Stroke

NCT ID: NCT02827864

Last Updated: 2020-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-30
• Study Completion Date: 2020-02-13

Brief Summary

This project is designed to investigate the intervention effects and time dependent effects of combining tDCS and MT in patients with subacute and chronic stroke.

Detailed Description

This project is also designed to investigate the optimal application timing of tDCS in combination with MT in patients with subacute and chronic stroke. Patients with subacute and chronic stroke will be recruited and randomized into one of the 3 groups: sequentially apply tDCS and MT group (SEQ), apply tDCS concurrently with MT group (CON), and MT with sham tDCS group (SHAM). All participants will receive 40 minutes of MT followed by 30 minutes of functional task training. For the participants in the SEQ group, 20 minutes of tDCS will be applied prior to MT, while tDCS will be applied concurrently with MT for the first 20 minutes in the CON group. As for the SHAM group, tDCS electrodes will be placed on the scalp without actual current output. The interventions will be carried out 90 minutes per day, 5 days per week, for 4 weeks. Behavioral outcomes will be assessed by blinded evaluators before, after, and 3 months post intervention. To study the possible interaction of treatment group and time of outcome evaluations, group (SEQ vs. CON vs. SHAM groups) × time (pretest vs. posttest vs. follow-up) repeated measures ANOVA will be performed. Additionally, the partial eta square (η2) will be calculated to determine the effect size of interest.

Conditions

Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

sequentially apply tDCS and MT

The participants in the SEQ group will first receive a-tDCS applied over M1 lesioned without any active arm practice for 20 minutes. For the following 20 minutes, the participants will receive the MT, while the electrodes will be remained on the scalp without stimulation (sham tDCS). Then the electrodes will be removed from the scalp, and the participants will continue another 20 minutes of MT without tDCS. The treatment session will be ended with 30 minutes of functional task practice.

Group Type: EXPERIMENTAL

sequentially apply tDCS and MT

Intervention Type: BEHAVIORAL

The participants in the SEQ group will first receive a-tDCS applied over M1lesioned without any active arm practice for 20 minutes. For the following 20 minutes, the participants will receive the MT, while the electrodes will be remained on the scalp without stimulation (sham tDCS). Then the electrodes will be removed from the scalp, and the participants will continue another 20 minutes of MT without tDCS. The treatment session will be ended with 30 minutes of functional task practice.

apply tDCS concurrently

For the participants in the CON group, sham tDCS will be first applied for 20 minutes without active arm practice. Twenty minutes of a-tDCS will then be applied concurrently with MT followed by another 20 minutes of MT without tDCS.

Similar to the SEQ group, the participants will also practice functional tasks for 30 minutes after MT.

Group Type: EXPERIMENTAL

apply tDCS concurrently

Intervention Type: BEHAVIORAL

Sham tDCS will be first applied for 20 minutes without active arm practice. Twenty minutes of a-tDCS will then be applied concurrently with MT followed by another 20 minutes of MT without tDCS. The participants will also practice functional tasks for 30 minutes after MT.

MT with sham tDCS

For the SHAM group, the training procedure will be the same as the above 2 groups except that sham tDCS will be provided in the first 40 minutes.

Group Type: SHAM_COMPARATOR

MT with sham tDCS

Intervention Type: BEHAVIORAL

The training procedure will be the same as the above 2 groups except that sham tDCS will be provided in the first 40 minutes.

Interventions

sequentially apply tDCS and MT

The participants in the SEQ group will first receive a-tDCS applied over M1lesioned without any active arm practice for 20 minutes. For the following 20 minutes, the participants will receive the MT, while the electrodes will be remained on the scalp without stimulation (sham tDCS). Then the electrodes will be removed from the scalp, and the participants will continue another 20 minutes of MT without tDCS. The treatment session will be ended with 30 minutes of functional task practice.

Intervention Type: BEHAVIORAL

apply tDCS concurrently

Sham tDCS will be first applied for 20 minutes without active arm practice. Twenty minutes of a-tDCS will then be applied concurrently with MT followed by another 20 minutes of MT without tDCS. The participants will also practice functional tasks for 30 minutes after MT.

Intervention Type: BEHAVIORAL

MT with sham tDCS

The training procedure will be the same as the above 2 groups except that sham tDCS will be provided in the first 40 minutes.

Intervention Type: BEHAVIORAL

Other Intervention Names

SEQ; CON; SHAM

Eligibility Criteria

Inclusion Criteria

1. experienced a first-ever unilateral stroke with stroke onset ≥ 1 week;

2. UE-FMA score between 18 and 56

3. able to follow instructions to perform the tasks (Mini Mental State Examination ≥ 24)

Exclusion Criteria

1. Participants are currently involved in other rehabilitation or drug research trial(s);

2. have neurological or psychological disorders other than stroke;

3. have joint contracture or excessive spasticity of the paretic upper limb that prohibits them performing the tasks;

4. received Botulinum toxin injections 3 months prior to enrollment

5. have unstable cardiovascular status such as uncontrolled hypertension or New York Heart Association (NYHA) Class III/IV heart failure;

6. have contradictions to tDCS including a history of epilepsy, migraine headache, uncontrolled medical status, being pregnant, having a pacemaker, or metal implanted in their head or body

7. have a history of drug or alcohol abuse, skin lesions on the electrode sites, brain tumor, brain injury, arteriovenous malformation (AVM), had brain surgery, other brain diseases (such as intracranial hypertension or cerebral edema), or being not suitable for using tDCS by the physician's assessment.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching-Yi Wu

Role: STUDY_CHAIR

Chang Gung University

Locations

Chang Gung Memorial Hospital

Songshan, Taipei, Taiwan

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

References

Liao WW, Chiang WC, Lin KC, Wu CY, Liu CT, Hsieh YW, Lin YC, Chen CL. Timing-dependent effects of transcranial direct current stimulation with mirror therapy on daily function and motor control in chronic stroke: a randomized controlled pilot study. J Neuroeng Rehabil. 2020 Jul 20;17(1):101. doi: 10.1186/s12984-020-00722-1.

Reference Type: DERIVED

PMID: 32690032 (View on PubMed)

Other Identifiers

104-9402A

Identifier Type: -

Identifier Source: org_study_id