Brainstem Stimulation for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Scion NeuroStim

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a double-blinded, controlled, randomized clinical trial (RCT) to establish the safety and efficacy of a non-invasive neuromodulation device for treating symptoms associated with Parkinson's disease.

Research Team

Eligibility Criteria

Adults aged 18-85 with Parkinson's disease, responding to medications for at least a year, and able to follow the study plan. They need a partner who can participate, stable medication use during the trial, access to smart devices for data collection, and must be fully vaccinated against COVID-19.

Inclusion Criteria

Have a study partner (defined as someone who sees the participant for more than one hour a day, 3 times per week) that is willing to consent and participate in the trial

I experience several non-movement symptoms due to Parkinson's.

I am fully vaccinated against COVID-19 with a WHO-approved vaccine.

See 14 more

Exclusion Criteria

I have an active ear infection or significant ear problems.

I use a pump for continuous dopamine medication.

I have a neurological condition that might show symptoms similar to Parkinson's disease.

See 19 more

Treatment Details

Interventions

Investigational treatment mode (stimulation pattern) (Neuromodulation Device)
Non-invasive brainstem stimulation (Neuromodulation Device)

Trial OverviewThe trial is testing a non-invasive brainstem stimulation device's safety and effectiveness in treating Parkinson's symptoms. Participants are randomly assigned to receive either this new treatment or a placebo without knowing which one they're getting.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Investigational Treatment 2Experimental Treatment1 Intervention

Investigational treatment mode (stimulation pattern) 2

Group II: Investigational Treatment 1Experimental Treatment1 Intervention

Investigational treatment mode (stimulation pattern) 1