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

Scion NeuroStim

Status: Terminated

Conditions: Parkinson's Disease

Treatments: Device: TNM Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02134795

Pro00053320

Details and patient eligibility

About

This is a single-center, open label study evaluating the acute effect of caloric vestibular stimulation on UPDRS motor scores in Parkinson's Disease patients.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Caloric Vestibular Stimulation (CVS)

Experimental group

Description:

Mild to moderate Parkinson's disease subjects will up to 3 sessions of 19 minutes each with the TNM Device during as many as 2 study visits: 2 sessions separated by 1 hour during the 1st study visit and 1 CVS session during a 2nd study visit.

Treatment:

Device: TNM Device