- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05174949
Targeted High-definition Transcranial Direct Current Stimulation (HD-tDCS) for Reducing Post-stroke Movement Impairments
Targeted HD-tDCS for Reducing Post-stroke Movement Impairments
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized, double-blinded, sham-controlled cross-over study will include three stimulation conditions: 1) anodal stimulation over the ipsilesional primary motor cortex, 2) cathodal one over the contralesional premotor cortex, 3) sham stimulation in chronic hemiparetic stroke patients.
Stroke participants (> 3 months after stroke) with moderate to severe motor impairments (Fugl-Meyer Motor Assessment - Upper Extremity score between 10-40, in absence of clinically defined sensory deficits) and an ischemic unilateral subcortical lesion will receive each type of stimulation for 20 minutes.
Their brain activity and behavior data will be collected for the outcome measures.
The patient time commitment in this study is approximately 7 weeks where subjects have 3 x 1-day intervention and measurements, with 2 weeks washout period in between.
The total number of potential enrolled subjects in this pilot study is 12.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yuan Yang, PhD
- Phone Number: 918-660-3290
- Email: yuan.yang-2@ou.edu
Study Contact Backup
- Name: Evgeny Sidorov, MD, PhD
- Phone Number: 405-271-4658
- Email: evgeny-sidorov@ouhsc.edu
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104-5036
- Recruiting
- University of Oklahoma Health Sciences Center
-
Contact:
- Evgeny Sidorov, PhD, MD
- Phone Number: 405-271-4658
- Email: evgeny-sidorov@ouhsc.edu
-
Principal Investigator:
- Yuan Yang, PhD
-
Principal Investigator:
- Evgeny Sidorov, PhD, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ischemic unilateral stroke lesion (confirmed by the most recent clinical or radiological reports) at least 3 months prior to participation in this project.
- Paresis confined to one side, with moderate to severe motor impairment of the upper limb (Fugl-Meyer upper extremity scores of 10-40)
- Capacity to provide informed consent
Exclusion Criteria:
- Muscle tone abnormalities and motor or sensory impairment in the unimpaired limb
- Severe wasting or contracture or significant sensory deficits in the paretic upper limb
- Severe cognitive or affective dysfunction that prevents normal communication and understanding of consent or instruction
- Severe concurrent medical problems (e.g. cardiorespiratory impairment)
- Using a pacemaker
- Metal implants in the head
- Known adverse reaction to TMS and tDCS
- Pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anodal stimulation
Anodal stimulation targeting hemisphere
|
Three conditions:
|
Experimental: Cathodal stimulation
Cathodal one at the contralesional hemisphere
|
Three conditions:
|
Experimental: Sham stimulation
Sham stimulation to the brain
|
Three conditions:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in a subset of Fugl-Meyer Upper Extremity assessment which is mainly related to the muscle synergies
Time Frame: Baseline (initial visit), before (within 30 min range) and immediately after (within 30 min range) the intervention
|
This measure determines the expression of the muscle synergy impairment after a stroke
|
Baseline (initial visit), before (within 30 min range) and immediately after (within 30 min range) the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Transcranial magnetic stimulation (TMS)-evoke motor-evoked potentials (MEP)
Time Frame: Baseline (initial visit), before (within 30 min range) and immediately after (within 30 mins range) the intervention
|
This is a neurophysiological measure that determines the use of ipsilesional corticospinal tract and the contralesional cortico-reticulospinal tract.
|
Baseline (initial visit), before (within 30 min range) and immediately after (within 30 mins range) the intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Brain symmetry index
Time Frame: Baseline (initial visit), before (within 30 min range) and immediately after (within 30 mins range) the intervention
|
This is a neurophysiological measure that determines the acute effort of HD-tDCS on brain plasticity.
|
Baseline (initial visit), before (within 30 min range) and immediately after (within 30 mins range) the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Williamson J, James SA, Apple B, Sharps J, Sidorov E.V., Yang Y, (2022), High Definition Transcranial Direct Current Stimulation for Improving Upper Extremity Motor Function post Stroke. June 8-10, the 3rd International Workshop on Non-Invasive Brain Stimulation (NIBS) 2022.
- Lepak L.V., Cheema C.F, James S.A., Yang Y (2023), Computer-Guided Non-Invasive High-Definition Transcranial Direct Current Brain Stimulation as a Targeted Intervention after a Stroke, American Physical Therapy Association (APTA) Combined Sections Meeting (CSM), San Diego, CA, Feb 23-25, 2023
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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