Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-29 @ 2:26 AM
Study NCT ID:
NCT06036368
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2023-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
Sponsor:
Stimvia s.r.o.
Organization:
Study Overview
Official Title:
6-weeks, Open-label, Single-Site Study to Evaluate Safety, Tolerability and Efficacy of the Home-based Peroneal Electrical Transcutaneous NeuroModulation (Peroneal eTNM®) Treatment Via Nerve Stimulator URIS ITM in Treatment of Symptoms Related to Movement Disorders in Subjects With Parkinson's Disease (PD) and Essential Tremor (ET)
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 6-week exploratory clinical study, designed to test whether treatment with peroneal electrical trans-cutaneous stimulation can have a beneficial effects on symptoms associated with Parkinson's diseases and essential tremor.
Detailed Description:
This is a 6-week, open-label, single site clinical study designed to test whether treatment with peroneal electrical trans-cutaneous stimulation (eTNM) can have a beneficial effects on symptoms associated with Parkinson's diseases (PD) and essential tremor (ET). Eligible patients will be treated with eTNM at home for 6 weeks. Primary endpoint in this study is tolerability and safety, secondary and exploratory endpoints are various scale designed to capture improvements in the most bothersome symptoms of PD or ET.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: