Personalized Transcranial Direct Current Stimulation in Stroke Recovery

Not Applicable

Not yet recruiting

• Conditions: Stroke
• Interventions: Device: Sham tDCS with OT; Device: Transcranial direct current stimulation (tDCS) with OT

• Registration Number: NCT06286800
• Lead Sponsor: The Methodist Hospital Research Institute

Brief Summary

The central objective of this application is to explore the neural substrate of personalized tDCS (ptDCS) and to determine whether the paradigm for each stroke patient can predict the amount of sustained clinical improvement through increased connectivity as measured by a biomarker of plasticity.

Detailed Description

This is a randomized, sham controlled double masked parallel group study with optional crossover of chronic (\>3mo from stroke onset) ischemic or hemorrhagic stroke patients to test the effect of ptDCS on a cerebral connectivity biomarker of plasticity during stimulation and after 10 treatment of up to 2 mA ptDCS. PtDCS will be performed during the first 20 minutes of occupational therapy targeting the weaker arm compared to sham. Patients will have the option to cross over after the completion of 1-month follow-up and will complete the same procedures with real tDCS if they were in the sham group.

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-02-29
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Study Start: 2024-12-14
• Primary Completion: 2026-03-14
• Study Completion: 2026-09-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Symptomatic ischemic or hemorrhagic stroke verified by computerized axial tomography or magnetic resonance imaging resulting in hemiparesis (MRC 1-4).
• Age more than 18, Male or Female, All racial and ethnic groups
• Entry into the study >3 months post onset
• Modified Ashworth Scale Score <3 in the involved upper extremity
• Passive range of motion within functional ranges at the shoulder, elbow, wrist and hand
• Able to follow 2 step commands

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Exclusion Criteria

• Patients with history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as unable to follow study instructions).
• Patients with bilateral paresis, or weakness or sensory damage due to peripheral causes (e.g. peripheral nerve injury, muscle or orthopedic injury etc.)
• Patients with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age,epilepsy or others).
• Patients with unstable cardiac arrhythmia.
• Pregnancy
• Patients with metallic implants in the head, patients with pacemakers, patients with craniotomies, including burr holes who cannot be safely stimulated
• Patients with seizures
• Non-English speaking individuals will only be eligible if they can provide the appropriate translator for all the sessions of the study as no funding is available to pay for such services.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS	Sham tDCS with OT	Same OT procedure and montage as with the active stimulation but the current will be increased then decreased ramp-like and switched off after 20 seconds instead of the 20 minutes to elicit the same cutaneous sensation as the other stimulation conditions.
Personalized Transcranial direct current stimulation (ptDCS)	Transcranial direct current stimulation (tDCS) with OT	TDCS is a noninvasive form of cortical stimulation that uses a battery-powered device. \[67\] Weak current (0.5-2 mA) will be delivered for up to 20 minutes through surface electrodes which will be positioned using the montage identified as the best in the individual stroke patient during our initial testing session during OT targeting the affected arm.

Primary Outcome Measures

Name	Time	Method
fMRI functional connectivity biomarker	baseline and 4 weeks	Task activation, resting state functional connectivity

Secondary Outcome Measures

Name	Time	Method
Wolf Motor Function Test	4 weeks	A time-based measurement of upper extremity function of 17 tasks. Shorter performance time is better.
Fugl-Meyer assessment	4 weeks	The upper extremity component of Fugl-Meyer test (uFM) is a widely used cumulative numeric rating tool that assesses motor impairment. Range is 0-66, higher score is better.