Trial Outcomes & Findings for A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease (NCT NCT02134795)
NCT ID: NCT02134795
Last Updated: 2025-05-02
Results Overview
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.
TERMINATED
NA
6 participants
Changes in motor score at 25, 50, 75, 100, 130, 160 and 220 minutes relative to baseline
2025-05-02
Participant Flow
Participant milestones
| Measure |
Caloric Vestibular Stimulation (CVS)
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Caloric Vestibular Stimulation (CVS)
n=6 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Changes in motor score at 25, 50, 75, 100, 130, 160 and 220 minutes relative to baselinePopulation: The study was halted early before any of the participants could complete this endpoint. Therefore, there is no outcome data to analyze.
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.
Outcome measures
Outcome data not reported
Adverse Events
Caloric Vestibular Stimulation (CVS)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place