N/A
Completed N=3
Optimizing Current and Electrode Montage for Transcranial Direct Current Stimulation in Stroke Patients
Source: ClinicalTrials.gov NCT02763826 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Number of Participants With Major Response — 0; 0; 0; 0 Participants
Summary
The purpose of this study is to determine the optimal transcranial direct current stimulation (tDCS) amplitude and electrode montage that is both safe and efficacious
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Response |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 18-80 years old with a first-ever ischemic stroke that occurred at least 6 months ago;
- Finished rehabilitation therapy(including inpatient or outpatient Physical Therapy (PT) / Occupational Therapy (OT) / Speech Therapy (SP)) at least one month ago;
- Unilateral limb weakness with Fugl Meyer-Upper Extremity Scale score less than 56 (out of 66);
- Motor Evoked Potentials (MEP) is inducible on abductor pollicis brevis (APB) muscle on the affected side by TMS.
Exclusion Criteria
- Primary intracerebral hematoma, or subarachnoid hemorrhage,
- Bihemispheric ischemic strokes;
- History of prior stroke or old infarct demonstrated on the CT or MRI or documented in medical records;
- Other concomitant neurological disorders affecting upper extremity motor function;
- Documented history of dementia before or after stroke;
- Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment;
- Uncontrolled hypertension despite treatment, specifically Systolic blood pressure (SBP)/ Diastolic Blood Pressure (DBP) >= 180/100 mmHg at baseline;
- Presence of any MRI/tDCS/TMS risk factors: a) an electrically, magnetically or mechanically activated metal or nonmetal implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system; b) non-fixed metal in any part of the body, including a previous metallic injury to eye; c) pregnancy, since the effect of tDCS on the fetus is unknown; d) history of seizure disorder or post-stroke seizure; e) preexisting scalp lesion, bone defect or hemicraniectomy.
Data sourced from ClinicalTrials.gov (NCT02763826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.