A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT02134795|
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : December 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Device: TNM (trade name), a form of brainstem Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Experimental: TNM (trade name), a form of brainstem stimulation
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
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.
- Motor UPDRS score (Unified Parkinson's Disease Rating Scale) [ Time Frame: 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.
- EKG to record beat-to-beat (R-R) interval data [ Time Frame: On a separate day, for a total of 40 minutes ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134795
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States, 27705|
|Study Director:||Lesco Rogers, MD||Scion NeuroStim|