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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43NS077652-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Rush University Medical Center | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purpose of this study is to evaluate the effects of transcranial direct current stimulation (tDCS) on patients with Parkinson's disease during sleep.
The clinical study will follow a counterbalanced crossover design during which subjects will undergo two separate pairs of two-consecutive-overnight sleep studies and receive anodal tDCS (active or sham) to M1. The first sleep study in each pair will acclimate subjects to the sleep laboratory and minimize "first night" effects, thus no tDCS will be applied. The second sleep study in each pair will include active or sham tDCS, presented in a pseudorandom order such that approximately half of the subjects receive active tDCS first while the other half receives sham first. The two pairs of sleep studies will be separated by one to three weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | Receives 20 minutes of anodal tDCS three times while sleeping during the night. |
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| Sham tDCS | Sham Comparator | Receives 20 minutes of sham tDCS three times while sleeping during the night. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tDCS | Procedure | Anodal tDCS will be applied over motor cortex for 20 minutes, three times during the night while the subject sleeps, each separated by 1 hour |
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| Measure | Description | Time Frame |
|---|---|---|
| PD motor scores measured by Kinesia HomeView | PD motor symptoms will be assessed for two days before (baseline) and two days after each tDCS sleep study using Kinesia HomeView. Changes for active tDCS will be compared to changes for sham tDCS. | Average change from two days before tDCS sleep study to two days after tDCS sleep study |
| Measure | Description | Time Frame |
|---|---|---|
| Sleepiness | Epworth Sleepiness Scale | Average change from two days before tDCS sleep study to two days after tDCS sleep study |
| tDCS sensations | Each subject will complete a questionnaire regarding sensations they felt during the night the day after each tDCS sleep study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dustin A Heldman, Ph.D. | Great Lakes NeuroTechnologies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Sham tDCS | Procedure | Sham tDCS will be applied over motor cortex for 20 minutes, three times during the night while the subject sleeps, each separated by 1 hour |
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| Day after tDCS sleep studies |
| Motor scores measured by the Unified Parkinson's Disease Rating Scale | Average change from day before tDCS sleep study to day after tDCS sleep study |
| Overnight Polysomnography | Polysomnography parameters will be compared during the active and sham tDCS sleep studies. | During each sleep study |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |