RecruitingNot ApplicableNCT06286800

Personalized Transcranial Direct Current Stimulation in Stroke Recovery

Sponsor

The Methodist Hospital Research Institute

Enrollment

80 participants

Start Date

Dec 18, 2024

Study Type

INTERVENTIONAL

Conditions

Stroke

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

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 Criteria8

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETranscranial 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.

DEVICESham 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.