Parkinson's Disease
Conditions
Keywords
Parkinson's disease
Brief summary
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.
Interventions
DEVICETNM 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.
Sponsors
Scion NeuroStim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient should have a UPDRS motor score of 14 (off medication) or higher (mild to moderate) * Patient should have a Hoehn & Yahr staging of 1 to 3 (mild to moderate) * Patient must be an adult (18 years of age or older)
Exclusion criteria
* Women who are pregnant or nursing * have a history of significant cardiovascular disease (no pacemakers) * have a history of unstable mood disorder or unstable anxiety disorder or psychosis * use a hearing aid * have a cochlear implant * have been diagnosed with neurological disease other than Parkinson's disease. No atypical parkinsonism. * have a diagnosed vestibular dysfunction * abuse alcohol or other drugs * have had eye surgery within the previous three months or ear surgery within the previous six months * have active ear infections or a perforated tympanic membrane * have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor UPDRS Score (Unified Parkinson's Disease Rating Scale) | Changes in motor score at 25, 50, 75, 100, 130, 160 and 220 minutes relative to baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Caloric Vestibular Stimulation (CVS) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Region of Enrollment United States | 6 Participants |
| Sex/Gender, Customized Unknown | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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.
Time frame: Changes in motor score at 25, 50, 75, 100, 130, 160 and 220 minutes relative to baseline
Population: The study was halted early before any of the participants could complete this endpoint. Therefore, there is no outcome data to analyze.