A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease

Study Overview
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Brief Summary
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This is a single-center, unblinded trial without placebo control to evaluate the acute effects of caloric vestibular stimulation on UPDRS motor scores in Parkinson's Disease patients.

Official Title
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A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: TNM (trade name), a form of brainstem Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNM (trade name), a form of brainstem stimulation<br>ThermoNeuroModulation (TNM) device with a standardized active neuromodulation 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. | Device: TNM (trade name), a form of brainstem Stimulation<br>* 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. The stimulation is non-invasive and non-electrical. The form of stimulation acts on the brainstem.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EKG to record beat-to-beat (R-R) interval data | Patient will have EKG recorded in order to calculate beat-to-beat (R-R) interval data as follows: 1) for 10 minutes prior to using the device, 2) during device use ( 19 minutes) and 3) for 10 minutes following device use. | On a separate day, for a total of 40 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease