Back to resultsA Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TNM (trade name), a form of brainstem Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease
Eligibility Criteria
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
Sites / Locations
- Duke University Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TNM (trade name), a form of brainstem stimulation
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
EKG to record beat-to-beat (R-R) interval data
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02134795
Brief Title
A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease
Official Title
A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scion NeuroStim
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TNM (trade name), a form of brainstem stimulation
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
TNM (trade name), a form of brainstem Stimulation
Intervention Description
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 Measure Information:
Title
Motor UPDRS score (Unified Parkinson's Disease Rating Scale)
Description
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.
Time Frame
Changes in motor score at 25, 50, 75, 100, 130, 160 and 220 minutes relative to baseline
Secondary Outcome Measure Information:
Title
EKG to record beat-to-beat (R-R) interval data
Description
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.
Time Frame
On a separate day, for a total of 40 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lesco Rogers, MD
Organizational Affiliation
Scion NeuroStim
Official's Role
Study Director
Facility Information:
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease
We'll reach out to this number within 24 hrs