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

December 20, 2016 updated by: Scion NeuroStim
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Changes in motor score at 25, 50, 75, 100, 130, 160 and 220 minutes relative to baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
On a separate day, for a total of 40 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scion NeuroStim

Investigators

  • Study Director: Lesco Rogers, MD, Scion NeuroStim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 6, 2014

First Submitted That Met QC Criteria

May 7, 2014

First Posted (Estimate)

May 9, 2014

Study Record Updates

Last Update Posted (Estimate)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNS-PD-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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