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Recruiting NCT06286800

Personalized Transcranial Direct Current Stimulation in Stroke Recovery

No phase Interventional Stroke Chronic Stroke Hemorrhage Brain Ischemic Stroke

For patients and families

In plain language

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial direct current stimulation (tDCS) with OT, Sham tDCS with OT.
Who it may be relevant to
Registry conditions: Stroke, Chronic Stroke, Hemorrhage Brain, Ischemic Stroke. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device 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 extre
  • Device 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 measures

  • fMRI functional connectivity biomarker [Time frame: baseline and 4 weeks]
Secondary outcome measures (2)
  • Wolf Motor Function Test [Time frame: 4 weeks]
  • Fugl-Meyer assessment [Time frame: 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Houston Methodist Hospital — Houston

Identifiers

NCT: NCT06286800 · PRO00036824

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗