- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05479006
Determine the Effect of Targeted High-definition Transcranial Direct Current Stimulation (tDCS) on Reducing Post-stroke Upper Limb Motor Impairments
Determine the Effect of Targeted High-definition tDCS on Reducing Post-stroke Upper Limb Motor Impairments
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This sham-controlled cross-over study design will include four visits: 1) anodal stimulation targeting the ipsilesional hemisphere, 2) cathodal one at the contralesional hemisphere, 3) bilateral stimulation with anodal on the ipsilesional hemisphere and cathodal on the contralesional hemisphere and 4) a sham stimulation visit. The sequence of the stimulations will be randomized and double-blinded (assessor and participants). After each intervention, there will be at least 2 weeks wash-out period before participants receive the next intervention and assessments. Each visit will last up to 3 hours including the preparation time and breaks.
We will use neuro-navigation high-definition tDCS (NNG HD-tDCS) to target specific brain regions in a more precise way than before. A subject-specific head model will be built to evaluate the effect of lesion size and location on the electrical field of tDCS. The MR images (if available, otherwise CT images) will be used to build this subject-specific head model. The stimulation electrode montage and inter-electrode distance will be carefully examined by computer simulation to determine the optimal setup and dosage for NNG HD-tDCS.
The patient time commitment in this study is approximately 10 weeks where subjects have 4 x 1-day intervention and measurements, with 2 weeks washout the period in between.
The total number of potential enrolled subjects in this pilot study is 30.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yuan Yang, PhD
- Phone Number: 217-244-5870
- Email: yuan.yang@carle.com
Study Contact Backup
- Name: Sanjiv Jain, MD
- Phone Number: 217-383-3800
- Email: sanjiv.jain@carle.com
Study Locations
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- Recruiting
- Carle Foundation Hospital
-
Principal Investigator:
- Yuan Yang, PhD, MS
-
Contact:
- Sanjiv Jain, MD
- Phone Number: 217-383-3800
- Email: sanjiv.jain@carle.com
-
Contact:
- Carly Skadden, MPH
- Phone Number: 1 217-326-0102
- Email: carly.skadden@carle.com
-
Sub-Investigator:
- Sanjiv Jain, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Paresis confined to one side, with substantial motor impairment of the paretic upper limb
- Capacity to provide informed consent
Exclusion Criteria:
- Muscle tone abnormalities and motor or sensory impairment in the non-paretic 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 reactions 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 |
---|---|
Active Comparator: Anodal stimulation
Anodal stimulation targets the primary motor cortex (arm area) in the lesioned hemisphere, sham on the contralesional hemisphere.
|
20 minutes, 2 mA stimulation.
|
Active Comparator: Cathodal stimulation
Cathodal stimulation targets the dorsal premotor cortex (arm area) in the contralesional hemisphere, sham on the lesioned hemisphere.
|
20 minutes, 2 mA stimulation.
|
Active Comparator: Bilateral Stimulation
Anodal stimulation targets the primary motor cortex (arm area) in the lesioned hemisphere and cathodal stimulation targets the dorsal premotor cortex (arm area) in the contralesional hemisphere at the same time.
|
20 minutes, 2 mA stimulation.
|
Sham Comparator: Sham stimulation
Sham stimulation to both hemisphere of the brain
|
20 minutes, 2 mA stimulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Transcranial Magnetic Stimulation-Evoke Motor-evoked Potential 1: Ispilesional stimulation in the brain and contralateral response in the muscle
Time Frame: Baseline (initial visit), before (within 30 min range) and immediately after (within 30 min range) the intervention
|
This is a neurophysiological measure that determines the use of the ipsilesional corticospinal tract.
|
Baseline (initial visit), before (within 30 min range) and immediately after (within 30 min range) the intervention
|
Change in Transcranial Magnetic Stimulation-Evoke Motor-evoked Potential 2: Contralesional stimulation in the brain and ipsilateral response in the muscle
Time Frame: Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
|
This is a neurophysiological measure that determines the use of the contralesional cortico-reticulospinal tract.
|
Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
|
Secondary 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 minutes range) and immediately after (within 30 minutes range) the intervention
|
This clinical measure is mainly related to the upper limb muscle synergies
|
Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
|
Change in Fugl-Meyer Upper Extremity assessment
Time Frame: Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
|
This reflects the overall motor impairment level.
|
Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Ashworth Scale
Time Frame: Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
|
This indicates the expression of muscle tone or spasticity
|
Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- McPherson JG, Stienen AH, Drogos JM, Dewald JP. Modification of Spastic Stretch Reflexes at the Elbow by Flexion Synergy Expression in Individuals With Chronic Hemiparetic Stroke. Arch Phys Med Rehabil. 2018 Mar;99(3):491-500. doi: 10.1016/j.apmr.2017.06.019. Epub 2017 Jul 24.
- Williamson JN, Sikora WA, James SA, Parmar NJ, Lepak LV, Cheema CF, Refai HH, Wu DH, Sidorov EV, Dewald JPA, Yang Y. Cortical Reorganization of Early Somatosensory Processing in Hemiparetic Stroke. J Clin Med. 2022 Oct 31;11(21):6449. doi: 10.3390/jcm11216449.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14906
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.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Transcranial direct current stimulation (high- definition)
-
Anhui Medical UniversityRecruitingAnxiety | Magnetic Resonance Imaging | Transcranial Direct Current StimulationChina
-
The University of Texas at DallasUniversity of Texas Southwestern Medical CenterRecruitingMemory Disorders | Word Finding DifficultyUnited States
-
Anhui Medical UniversityRecruitingDepressive Disorder | Functional Magnetic Resonance Imaging | Transcranial Direct Current StimulationChina
-
University of Texas Rio Grande ValleyRecruitingSpinal Cord Diseases | Spinal Cord InjuriesUnited States
-
Anhui Medical UniversityRecruitingTranscranial Magnetic Stimulation | Functional Magnetic Resonance Imaging | Refractory Epilepsy | Transcranial Direct Current Stimulation | EEGChina
-
Anhui Medical UniversityRecruitingTranscranial Direct Current Stimulation | Non Suicidal Self InjuryChina
-
University of TehranRecruitingHealthy VolunteersIran, Islamic Republic of
-
University of New MexicoUniversity of Miami; The City College of New York; The Mind Research Network; New... and other collaboratorsCompletedMild Traumatic Brain InjuryUnited States
-
Monash UniversityZonMw: The Netherlands Organisation for Health Research and Development; Erasmus...Completed
-
Shanghai Mental Health CenterRecruitingObsessive-Compulsive DisorderChina