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The purpose of this research study is to determine whether brain anatomy impacts the efficacy of transcranial magnetic stimulation (TMS) which is a form of non-invasive brain stimulation. TMS is used to stimulate different areas of the brain and it is well tolerated and generally a safe procedure. It has been studied by researchers for 20 plus years. This brain stimulation device and technique used in this study is an investigational device that has not been approved by the U.S. FDA for treating any muscle or nerve problems. A copy of the device brochure can be found at: https://www.magstim.com/product/rapid-family/
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain stimulation over bicep muscle than finger (FDI) muscle. | Experimental | Brain stimulation will occur over two sessions. Both sessions will occur with sham stimulation then active stimulation. There will be a 3 day rest period between the two muscle groups. |
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| Brain stimulation over than finger (FDI) muscle than bicep muscle. | Experimental | Brain stimulation will occur over two sessions. Both sessions will occur with sham stimulation then active stimulation. There will be a 3 day rest period between the two muscle groups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle | Device | repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Corticomotor Excitability With Active Stimulation on Bicep Muscle | The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability | approximately 7 days |
| Change in Corticomotor Excitability With Sham Stimulation on Bicep Muscle | The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability | approximately 7 days |
| Change in Corticomotor Excitability With Active Stimulation on Finger Muscle | The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability | approximately 7 days |
| Change in Corticomotor Excitability With Sham Stimulation on Finger Muscle | The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability | approximately 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carrie Peterson, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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Total enrollment was 12 with all participants receiving both interventions
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| ID | Title | Description |
|---|---|---|
| FG000 | Brain Stimulation: Biceps Then FDI | Brain stimulation |
| FG001 | Brain Stimulation: FDI Then Biceps | Brain stimulation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | May 20, 2021 |
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Participants will not be able to tell the difference if they are being given active vs sham stimulation but will receive both.
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| intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle | Device | repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head |
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| Sham Stimulation | Will occur over biceps or FDI depending on which area is being stimulated first |
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| Active Stimulation | Will occur over biceps or FDI depending on which area is being stimulated first |
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| 3 Day Rest |
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| Sham Stimulation | Will occur over biceps or FDI depending on which area is being stimulated second |
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| Active Stimulation | Will occur over biceps or FDI depending on which area is being stimulated second |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | This combines both groups. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Normalized corticomotor excitability | MEP amplitudes were calculated from the motor target EMG data of each session. Root mean square (RMS) amplitude was calculated for the evoked response over 50ms window (12-62ms post TMS pulse), & for 50ms window prior to the TMS pulse (pre-stimulus). Instances where pre-stimulus RMS exceeded evoked response RMS were excluded. MEPs then normalized & presented as a percentage of the MVC EMG. Normalized MEPs (nMEPs) served as measure of corticomotor excitability, with average of nMEPs collected prior to iTBS serving as baseline. A higher value of nMEP represents greater corticomotor excitability. | Mean | Standard Deviation | Unitless (a normalized value) |
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| 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 | Change in Corticomotor Excitability With Active Stimulation on Bicep Muscle | The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability | nonimpaired | Posted | Mean | Standard Deviation | percentage of Mwave | approximately 7 days |
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| Primary | Change in Corticomotor Excitability With Sham Stimulation on Bicep Muscle | The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability | Posted | Mean | Standard Deviation | percentage of Mwave | approximately 7 days |
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| Primary | Change in Corticomotor Excitability With Active Stimulation on Finger Muscle | The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability | Posted | Mean | Standard Deviation | percentage of Mwave | approximately 7 days |
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| Primary | Change in Corticomotor Excitability With Sham Stimulation on Finger Muscle | The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability | Posted | Mean | Standard Deviation | percentage of Mwave | approximately 7 days |
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1 year
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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 | Brain Stimulation | intermittent theta burst stimulation (iTBS): repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head | 0 | 12 | 0 | 12 | 0 | 12 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carrie Peterson | Virginia Commonwealth University | 804 827 5270 | clpeterson@vcu.edu |
| Sep 5, 2023 |
| Prot_SAP_000.pdf |
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| >=65 years |
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