Recruiting

Transcranial Direct Current Stimulation

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT06286800

Conditions

Stroke

Chronic Stroke

Hemorrhage Brain

Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcranial direct current stimulation (tDCS) with OT

Sham tDCS with OT

Study Details

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.

Conditions

Stroke

Chronic Stroke

Hemorrhage Brain

Ischemic Stroke

Study ID

NCT06286800

Start date

Dec 18, 2024

Status verified date

Feb, 2026

Completion date

Sep 14, 2027

Anticipated

Primary completion date

Mar 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Personalized Transcranial direct current stimulation (ptDCS)

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.

placebo comparator: Sham tDCS

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.

Interventions

Transcranial direct current stimulation (tDCS) with OT

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.

Sham tDCS with OT

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.

Primary outcome measure

  • fMRI functional connectivity biomarker [ Time Frame: baseline and 4 weeks ]

Central Contacts and Locations

Central contacts

Neha Sudarshan, MD

9082277275nsudarshan@houstonmethodist.org

Timea Hodics, MD

281-381-1728tmhodics@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Timea Hodics, MD

713-763-9589tmhodics@houstonmethodist.org

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • tdcs
  • noninvasive cortical stimulation
  • functional connectivity
  • hemiparesis
  • arm weakness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-03-02.