Personalized Transcranial Direct Current Stimulation in Stroke Recovery
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Dec 2024
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2024
CompletedFirst Posted
Study publicly available on registry
February 29, 2024
CompletedStudy Start
First participant enrolled
December 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 14, 2027
March 2, 2026
February 1, 2026
2.2 years
February 21, 2024
February 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
fMRI functional connectivity biomarker
Task activation, resting state functional connectivity
baseline and 4 weeks
Secondary Outcomes (2)
Wolf Motor Function Test
4 weeks
Fugl-Meyer assessment
4 weeks
Study Arms (2)
Personalized Transcranial direct current stimulation (ptDCS)
EXPERIMENTALTDCS 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.
Sham tDCS
PLACEBO COMPARATORSame 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.
Interventions
Weak direct current (0.5-2 mA) will be delivered for up to 20 minutes through surface electrodes which will be positioned using the ptDCS montage. The current will be increased and decreased ramp-like at the beginning and end of the 20-minute stimulation to lessen the itchy/numb skin sensation and decrease the likelihood of an innocuous phosphene-like visual phenomenon. The stimulation will be delivered during the first 20 minutes of occupational therapy targeted to the more affected upper extremity.
Same 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. \[69\] This short length of stimulation is documented to elicit sensations comparable to those of real stimulation. With this procedure, subjects were unable to differentiate between tDCS and sham stimulation in our and other previous studies.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Houston Methodist Hospital
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timea Hodics, MD
The Methodist Hospital Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Interventional Neuro-Recovery Program
Study Record Dates
First Submitted
February 21, 2024
First Posted
February 29, 2024
Study Start
December 18, 2024
Primary Completion (Estimated)
March 14, 2027
Study Completion (Estimated)
September 14, 2027
Last Updated
March 2, 2026
Record last verified: 2026-02