Study Stopped
The study aimed to enroll 10 patients but only enrolled 6 total. Instead of keeping the study open, it was terminated early with incomplete results.
A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 6, 2014
CompletedFirst Posted
Study publicly available on registry
May 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
May 2, 2025
CompletedMay 2, 2025
April 1, 2025
4 months
May 6, 2014
March 25, 2025
April 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Caloric Vestibular Stimulation (CVS)
EXPERIMENTALMild to moderate Parkinson's disease subjects will up to 3 sessions of 19 minutes each with the TNM Device during as many as 2 study visits: 2 sessions separated by 1 hour during the 1st study visit and 1 CVS session during a 2nd study visit.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scion NeuroStimlead
Study Sites (1)
Duke University Health System
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study did not achieve full enrollment and was, therefore, halted. This occurred before participants were able to complete outcomes measures, and, therefore, prevented outcome analysis.
Results Point of Contact
- Title
- Dr. Robert Black
- Organization
- Scion NeuroStim
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2014
First Posted
May 9, 2014
Study Start
May 1, 2014
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
May 2, 2025
Results First Posted
May 2, 2025
Record last verified: 2025-04