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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02134795
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : December 22, 2016
Information provided by (Responsible Party):
Scion NeuroStim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: TNM (trade name), a form of brainstem Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02134795

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United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Scion NeuroStim
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Study Director: Lesco Rogers, MD Scion NeuroStim
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Responsible Party: Scion NeuroStim Identifier: NCT02134795    
Other Study ID Numbers: SNS-PD-01
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Keywords provided by Scion NeuroStim:
Parkinson's disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases