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Personalized Transcranial Direct Current Stimulation in Stroke Recovery

ConditionsStrokeChronic StrokeHemorrhage BrainIschemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Methodist Hospital Research Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial direct current stimulation (tDCS) with OT

    Device

    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

    Device

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Personalized Transcranial direct current stimulation (ptDCS)Experimental treatment 1 intervention
Group B: Sham tDCSPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

fMRI functional connectivity biomarker

Task activation, resting state functional connectivity

Time frame
baseline and 4 weeks
2

Fugl-Meyer assessment

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.

Time frame
4 weeks

Secondary outcomes

1

Wolf Motor Function Test

A time-based measurement of upper extremity function of 17 tasks. Shorter performance time is better.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Methodist Hospital Research Institute

Lead sponsor

Source ClinicalTrials.gov
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