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| Name | Class |
|---|---|
| Oklahoma Shared Clinical and Translational Resources | OTHER |
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Stroke is the leading cause of serious, long-term disability. The emergence of abnormal muscle synergies following a stroke presents a major limitation to the recovery of independent function. Despite the development of many interventions for movement recovery post-stroke, rehabilitation treatments are minimally effective to the muscle synergy impairment. Previous studies have found that muscle synergy impairment is associated with the damage to the corticospinal tract and the maladaptive recruitment of the contralesional cortico-reticulospinal tract. The investigators hypothesize that facilitating the damaged cortico-spinal tract (via primary motor cortex) and/or inhibiting the contralesional cortico-reticulospinal tract (via dorsal premotor cortex) will reduce muscle synergy impairment. In this pilot project, the investigators propose to run a proof-of-concept pilot trial to evaluate the effect of the targeted high-definition transcranial direct current stimulation (HD-tDCS) on mitigating muscle synergy impairment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham, Anodal, Cathodal | Experimental | Treatment order 1: Sham, Anodal, Cathodal |
|
| Anodal, Cathodal, Sham | Experimental | Treatment order 2: Anodal, Cathodal, Sham |
|
| Cathodal, Sham, Anodal | Experimental | Treatment order 3: Cathodal, Sham, Anodal |
|
| Sham, Cathodal, Anodal | Experimental | Treatment order 4: Sham, Cathodal, Anodal |
|
| Cathodal, Anodal, Sham | Experimental | Treatment order 5: Cathodal, Anodal, Sham |
|
| Anodal, Sham, Cathodal | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation (high-definition) | Device | Three conditions (2 mA, 20 mins):
|
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Upper Extremity Assessment Part A | The Fugl-Meyer Upper Extremity (FM-UE) subset is a component of the Fugl-Meyer Assessment (FM) assessing motor impairment in individuals with stroke or other arm impairments. The (FM-UE) subset focuses on evaluating motor impairment and recovery using movements assessing strength, coordination, sensation, and range of motion of the upper extremity. Each item in the FM-UE subset is scored on a scale from 0-2. These are added together, with higher scores indicating better motor function. The FM-UE subset has 33 items for a maximum possible (highest functioning) score of 66. | The FM-UE assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intenvention) and recorded for each treatment group (anodal, cathodal, and sham). . |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Onset Latency of Transcranial Magnetic Stimulation (TMS)-Evoke Motor-evoked Potentials (MEP) | This is a neurophysiological measure that determines the use of ipsilesional corticospinal tract. The paired-pulse TMS was applied at the respective hotspot for the elbow flexor muscle at the paretic arm over the ipsilesional primary motor cortex. The center of the coil was positioned tangentially to the skull. The patient was considered MEP+ if MEPs of any amplitude are observed at a consistent latency on at least 5 out 10 trials. After determining the status of MEP, at least eight more pulses were applied. We calculated average latency across all positive trials to determine the latency of MEP. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brain Symmetry Index | This is a neurophysiological measure used to quantify the symmetry or asymmetry between the left and right hemispheres of the brain. It was calculated using EEG data from a 3-minute resting state EEG recording. The scale of the index is from -1 to 1, where zero is considered perfect symmetry between hemispheres and values close to -1 and 1 indicate asymmetry. | The BSI assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intevention) and recorded for each treatment group (anodal, cathodal, and sham). |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104-5036 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| Result | 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 | ||
| 37900725 | Derived | Williamson JN, James SA, He D, Li S, Sidorov EV, Yang Y. High-definition transcranial direct current stimulation for upper extremity rehabilitation in moderate-to-severe ischemic stroke: a pilot study. Front Hum Neurosci. 2023 Oct 12;17:1286238. doi: 10.3389/fnhum.2023.1286238. eCollection 2023. |
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We are committed to enhancing the value of research and furthering the advancement of public knowledge. We recognize that the public dissemination of our scientific results can facilitate the creation of collaborative efforts with domestic and international collaborators. Furthermore, we recognize that the proposed project may result in novel ideas for new methods, technologies, and data that could benefit the entire research community. Therefore, final research data will be shared openly and timely in accordance with the most recent NIH guidelines (http://grants.nih.gov/grants/policy/data\_sharing/) while being mindful that the confidentiality and privacy of participants in research must be protected at all times.
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Stroke participants will be examined by the study doctor to verify their admissibility to the study based on the inclusion criteria. Participants will then undergo the upper extremity portion of the Fugl-Meyer Motor Assessment, and a structured interview pertaining to the inclusion criteria.
Our primary patient resource is from OU Physician Neurology Clinic and Allied Health Clinical Network. We also seek referrals from clinicians in the Oklahoma City areas and recruit stroke survivors residing in these two areas who wish to participate in the study. The recruitment method include doctor referrals and direct contact (if study doctor's patients) via the study doctor. Recruitment period: 1/18/2022-5/12/2023
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham, Anodal, Cathodal | Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins) with 2-week wash-out period:
|
| FG001 | Anodal, Cathodal, Sham | Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins):
|
| FG002 | Cathodal, Sham, Anodal | Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins):
|
| FG003 | Sham, Cathodal, Anodal | Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins):
|
| FG004 | Cathodal, Anodal, Sham | Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins):
|
| FG005 | Anodal, Sham, Cathodal | Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins):
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline demographics taken from the per-protocol (PP) population; the PP group includes all participants who signed an informed consent, were randomized to a treatment arm, and completed the baseline assessment. There is one subject is loss of follow-up before the baseline assessment, resulting in a total of 13 subjects included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham, Anodal, Cathodal | Treatment order 1: Sham, Anodal, Cathodal Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins):
|
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fugl-Meyer Upper Extremity Assessment Part A | The Fugl-Meyer Upper Extremity (FM-UE) subset is a component of the Fugl-Meyer Assessment (FM) assessing motor impairment in individuals with stroke or other arm impairments. The (FM-UE) subset focuses on evaluating motor impairment and recovery using movements assessing strength, coordination, sensation, and range of motion of the upper extremity. Each item in the FM-UE subset is scored on a scale from 0-2. These are added together, with higher scores indicating better motor function. The FM-UE subset has 33 items for a maximum possible (highest functioning) score of 66. | Eight subjects completed the study were analyzed. | Posted | Mean | Standard Deviation | score on a scale | The FM-UE assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intenvention) and recorded for each treatment group (anodal, cathodal, and sham). . |
|
1 year, 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anodal Stimulation | Anodal stimulation over the ipsilesional primary motor cortex |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yuan Yang (Principal Investigator) C/o Dr. Shirley James (Project Biostatistician) | University of Oklahoma Health Sciences Center | 4052712131 | 46812 | shirley-james@ouhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 24, 2021 | May 24, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 9, 2022 | May 24, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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This sham-controlled cross-over study design will include three visits: 1) anodal stimulation targeting ipsilesional primary motor cortex, 2) cathodal one at the contralesional premotor cortex, 3) a sham stimulation visit. The sequence of the stimulations will be randomized and double-blinded. After each intervention, there will be at least 2 weeks wash-out period before participants receive the next intervention and assessments.
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Treatment order 6: Anodal, Sham, Cathodal |
|
| The latency of TMS-evoke MEP assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intevention) and recorded for each treatment group (anodal, cathodal, and sham). |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Anodal, Cathodal, Sham |
Treatment order 2: Anodal, Cathodal, Sham Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins):
|
| BG002 | Cathodal, Sham, Anodal | Treatment order 3: Cathodal, Sham, Anodal Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins):
|
| BG003 | Sham, Cathodal, Anodal | Treatment order 4: Sham, Cathodal, Anodal Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins):
|
| BG004 | Cathodal, Anodal, Sham | Treatment order 5: Cathodal, Anodal, Sham Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins):
|
| BG005 | Anodal, Sham, Cathodal | Treatment order 6: Anodal, Sham, Cathodal Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins):
|
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Subset of Fugl-Meyer Upper Extremity assessment which is mainly related to the muscle synergy | The Fugl-Meyer Upper Extremity (FM-UE) subset is a component of the Fugl-Meyer Assessment (FM) assessing motor impairment in individuals with stroke or other arm impairments. The (FM-UE) subset focuses on evaluating motor impairment and recovery using movements assessing strength, coordination, sensation, and range of motion of the upper extremity. Each item in the FM-UE subset is scored on a scale from 0-2. These are added together, with higher scores indicating better motor function. The FM-UE subset has 33 items for a maximum possible (highest functioning) score of 66. | Mean | Standard Deviation | units on a scale |
|
| Onset Latency of Transcranial magnetic stimulation (TMS)-evoke motor-evoked potentials (MEP) | The TMS-induced MEP were assessed to determine the ipsilesional corticospinal tract. The paired-pulse TMS was applied at the respective hotspot for the elbow flexor muscle at the paretic arm over the ipsilesional primary motor cortex. The center of the coil was positioned tangentially to the skull. The patient was considered MEP+ if MEPs of any amplitude are observed at a consistent latency on at least 5 out 10 trials. After determining the status of MEP, at least eight more pulses were applied. We calculated average latency across all positive trials to determine the latency of MEP. | Mean | Standard Deviation | ms |
|
| Brain symmetry index | The brain symmetry index is a measure used to quantify the symmetry or asymmetry between the left and right hemispheres of the brain. It was calculated using EEG data from a 3-minute resting state EEG recording. The scale of the index is from -1 to 1, where zero is considered perfect symmetry between hemispheres and values close to -1 and 1 indicate asymmetry. | Mean | Standard Deviation | Index |
|
Anodal stimulation over the ipsilesional primary motor cortex |
| OG001 | Cathodal Stimulation | Cathodal stimulation over the contralesional premotor cortex. |
| OG002 | Sham | Sham stimulation |
|
|
|
| Secondary | Change in Onset Latency of Transcranial Magnetic Stimulation (TMS)-Evoke Motor-evoked Potentials (MEP) | This is a neurophysiological measure that determines the use of ipsilesional corticospinal tract. The paired-pulse TMS was applied at the respective hotspot for the elbow flexor muscle at the paretic arm over the ipsilesional primary motor cortex. The center of the coil was positioned tangentially to the skull. The patient was considered MEP+ if MEPs of any amplitude are observed at a consistent latency on at least 5 out 10 trials. After determining the status of MEP, at least eight more pulses were applied. We calculated average latency across all positive trials to determine the latency of MEP. | Eight subjects completed the study were analyzed. | Posted | Mean | Standard Deviation | ms | The latency of TMS-evoke MEP assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intevention) and recorded for each treatment group (anodal, cathodal, and sham). |
|
|
|
|
| Other Pre-specified | Change in Brain Symmetry Index | This is a neurophysiological measure used to quantify the symmetry or asymmetry between the left and right hemispheres of the brain. It was calculated using EEG data from a 3-minute resting state EEG recording. The scale of the index is from -1 to 1, where zero is considered perfect symmetry between hemispheres and values close to -1 and 1 indicate asymmetry. | 1 missing data for anodal and sham stimulation caused by a device failure. | Posted | Mean | Standard Deviation | score on a scale | The BSI assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intevention) and recorded for each treatment group (anodal, cathodal, and sham). |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Cathodal Stimulation | Cathodal stimulation over the contralesional premotor cortex. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Sham | Sham stimulation | 0 | 8 | 0 | 8 | 0 | 8 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |