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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134795
• Other study ID #: SNS-PD-01
• Status: Completed
• Phase: N/A
• First received: May 6, 2014
• Last updated: December 20, 2016
• Start date: May 2014
• Est. completion date: September 2014

Study information

• Verified date: December 2016
• Source: Scion NeuroStim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Scion NeuroStim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	On a separate day, for a total of 40 minutes	No