CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 188 enrolled
Drug / intervention
TNM Devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04797611
NCT04797611N/ACompleted
CompareCT.gov

Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease: A Randomized Controlled Trial (RCT)

Scion NeuroStim·interventional·Posted Mar 15, 2021·Updated May 13, 2025

In Brief

A clinical study evaluating TNM Device for Parkinson Disease and Parkinson's Disease and Parkinsonism. Completed, enrolled 188 participants across 23 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease, Parkinson's Disease and Parkinsonism
CountriesUnited Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 15, 2021
Enrollment StartMay 19, 2022
Primary CompletionDec 6, 2024
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 5.3 years ago

Interventions

TNM Devicedevice

Study participants will self-administer \~19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive tvCVS device. The device has been deemed to be a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration.