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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS058487 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The study will include subjects diagnosed with Dystonic Tremor (DT), Essential Tremor (ET), and healthy controls in the age range of 21-80 years. Electroencephalography (EEG) will be used as the primary outcome measure. Transcranial Magnetic Stimulation (TMS) will be used over the motor cortices or cerebellar cortices as an intervention that is expected to have short-term (less than an hour) electrophysiological effects.
The primary goal of this study is to compare differences in cortical activity of patients with tremor before and after applying a session of rTMS. Specifically, the investigators will apply rTMS to the primary motor cortex (M1) as our group and others have shown abnormal function of the region. Moreover, a study shows that targeting of M1 and the dorsal premotor cortex (dPMC) with rTMS results in a trend towards improved clinical outcome in patients with focal hand dystonia and cervical dystonia. The central hypothesis of this study is that rTMS can modify cortical oscillations in patient populations with tremor and that the investigators will be able to detect these changes with the use of Electroencephalography (EEG). By applying inhibitory rTMS to the motor cortices, the investigators may expect a shift in cortical oscillations towards normal activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dystonia and/or tremor | Experimental | Adults with a diagnosis of dystonia and/or tremor |
|
| Control | Experimental | Healthy adults without a history of any neurological disorder, with a similar age distribution and sex ratio as the dystonia and/or tremor group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetitive Transcranial Magnetic Stimulation (rTMS) | Device | Repetitive transcranial magnetic stimulation (rTMS) is a form of brain stimulation therapy using a magnet to target and stimulate certain areas of the brain. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Assessment Using MoCA Version 7.1 Scores | Montreal Cognitive Assessment Version 7.1 was used to assess cognitive ability. This scales is score from a range of 0 to 30 with a score of 24 or less indicating mild cognitive impairment. Moderate cognitive impairment is indicated by a score of 18-23 and severe impairment is a score of 10 or less. Overall, a higher number indicates better cognitive ability. | Day 1 |
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Inclusion Criteria for Dystonia and/or tremor:
- Diagnosis of Dystonia and/or tremor according to the Consensus Statement of the Movement Disorders Society
Exclusion Criteria Dystonia and/or tremor:
Inclusion Criteria for Healthy controls
- There is no history of any neurological disorders.
Exclusion Criteria for Healthy controls
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| Name | Affiliation | Role |
|---|---|---|
| David Vaillancourt, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32608 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dystonia and/or Tremor | Adults with a diagnosis of dystonia and/or tremor repetitive Transcranial Magnetic Stimulation (rTMS): Repetitive transcranial magnetic stimulation (rTMS) is a form of brain stimulation therapy using a magnet to target and stimulate certain areas of the brain. |
| FG001 | Control | Healthy adults without a history of any neurological disorder, with a similar age distribution and sex ratio as the dystonia and/or tremor group Control group: No application of rTMS |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dystonia and/or Tremor | Adults with a diagnosis of dystonia and/or tremor repetitive Transcranial Magnetic Stimulation (rTMS): Repetitive transcranial magnetic stimulation (rTMS) is a form of brain stimulation therapy using a magnet to target and stimulate certain areas of the brain. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Cognitive Assessment Using MoCA Version 7.1 Scores | Montreal Cognitive Assessment Version 7.1 was used to assess cognitive ability. This scales is score from a range of 0 to 30 with a score of 24 or less indicating mild cognitive impairment. Moderate cognitive impairment is indicated by a score of 18-23 and severe impairment is a score of 10 or less. Overall, a higher number indicates better cognitive ability. | Posted | Mean | Standard Deviation | units on a scale | Day 1 |
|
approximately 7 days a part
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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 | Dystonia and/or Tremor | Adults with a diagnosis of dystonia and/or tremor repetitive Transcranial Magnetic Stimulation (rTMS): Repetitive transcranial magnetic stimulation (rTMS) is a form of brain stimulation therapy using a magnet to target and stimulate certain areas of the brain. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Vaillancourt | University of Florida | (352) 294 - 1770 | vcourt@ufl.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 | May 24, 2021 | Jun 13, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 24, 2021 | Jun 13, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004421 | Dystonia |
| D014202 | Tremor |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
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| Control group | Other | No application of rTMS |
|
| Control |
Healthy adults without a history of any neurological disorder, with a similar age distribution and sex ratio as the dystonia and/or tremor group Control group: No application of rTMS |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Healthy adults without a history of any neurological disorder, with a similar age distribution and sex ratio as the dystonia and/or tremor group Control group: No application of rTMS |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Control | Healthy adults without a history of any neurological disorder, with a similar age distribution and sex ratio as the dystonia and/or tremor group Control group: No application of rTMS | 0 | 1 | 0 | 1 | 0 | 1 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |