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

Not Applicable

Terminated

• Conditions: Parkinson's Disease
• Interventions: Device: TNM (trade name), a form of brainstem Stimulation

• Registration Number: NCT02134795
• Lead Sponsor: Scion NeuroStim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2025-03-25
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Results First Posted: 2025-05-02
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TNM (trade name), a form of brainstem stimulation	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States