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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
Sponsor:
Information provided by (Responsible Party):
Scion NeuroStim

Tracking Information
First Submitted Date  ICMJE May 6, 2014
First Posted Date  ICMJE May 9, 2014
Last Update Posted Date December 22, 2016
Study Start Date  ICMJE May 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease
Official Title  ICMJE A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: TNM (trade name), a form of brainstem Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2014)
6
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2014)
10
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02134795
Other Study ID Numbers  ICMJE SNS-PD-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Scion NeuroStim
Study Sponsor  ICMJE Scion NeuroStim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lesco Rogers, MD Scion NeuroStim
PRS Account Scion NeuroStim
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP