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The study aimed to enroll 10 patients but only enrolled 6 total. Instead of keeping the study open, it was terminated early with incomplete results.
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This is a single-center, open label study evaluating the acute effect of caloric vestibular stimulation on UPDRS motor scores in Parkinson's Disease patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caloric Vestibular Stimulation (CVS) | Experimental | Mild to moderate Parkinson's disease subjects will up to 3 sessions of 19 minutes each with the TNM Device during as many as 2 study visits: 2 sessions separated by 1 hour during the 1st study visit and 1 CVS session during a 2nd study visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNM Device | Device | The noninvasive device is worn like a music headset and the patient lies back on a wedge pillow while the device is active. Each session lasts under 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Motor UPDRS Score (Unified Parkinson's Disease Rating Scale) | A motor score prior to use of the device will be established (time zero), the motor test will be repeated after the first use of the device (times 25, 50, and 75 minutes), and then after a second use of the device (times 100, 130, 160 and 220). Any changes in motor scores at the various time points will be noted. A videotape of the motor UPDRS examination will be obtained at baseline and during the final test. | Changes in motor score at 25, 50, 75, 100, 130, 160 and 220 minutes relative to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Caloric Vestibular Stimulation (CVS) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Caloric Vestibular Stimulation (CVS) | ThermoNeuroModulation (TNM) device with a standardized active CVS waveform will be used for all patients. The device will be used twice for ~19 minutes each time. There will be a gap of roughly 1 hour between the two device applications. The device is worn like a music headset and the patient lies on a wedge pillow while the device is active. Each session lasts under 20 minutes. |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 | Motor UPDRS Score (Unified Parkinson's Disease Rating Scale) | A motor score prior to use of the device will be established (time zero), the motor test will be repeated after the first use of the device (times 25, 50, and 75 minutes), and then after a second use of the device (times 100, 130, 160 and 220). Any changes in motor scores at the various time points will be noted. A videotape of the motor UPDRS examination will be obtained at baseline and during the final test. | The study was halted early before any of the participants could complete this endpoint. Therefore, there is no outcome data to analyze. | Posted | Changes in motor score at 25, 50, 75, 100, 130, 160 and 220 minutes relative to baseline |
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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 | Caloric Vestibular Stimulation (CVS) | 0 | 6 |
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The study did not achieve full enrollment and was, therefore, halted. This occurred before participants were able to complete outcomes measures, and, therefore, prevented outcome analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Black | Scion NeuroStim | (919) 260-5528 | rblack@scionneurostim.com |
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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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| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 0 |
| 6 |
| 0 |
| 6 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |