Houston Methodist Hospital
Houston, Texas, 77030, United States
Location status: Recruiting
NCT Number: NCT06286800
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: baseline and 4 weeks
Task activation, resting state functional connectivity
Time frame: 4 weeks
A time-based measurement of upper extremity function of 17 tasks. Shorter performance time is better.
Time frame: 4 weeks
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.
Contact information is provided by the study sponsor or research team.
Neha Sudarshan, MD
CONTACT
Timea Hodics, MD
CONTACT
The Methodist Hospital Research Institute
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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