Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570421
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
24-months Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinsons Disease and Essential Tremor
Sponsor:
None
Organization:
None
Study Overview
Official Title:
24-months Open-label Single-Site Extension 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 Parkinsons Disease PD and Essential Tremor ET
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study investigates the long-term safety and tolerability of home peroneal eTNM therapy using the URIS I device in subjects with Parkinsons disease PD or Essential Tremor ET Previously a 6-week open-label pilot study with 24 PD or ET patients demonstrated that home-based peroneal eTNM is safe well-tolerated and has a high adherence rate of over 90 No treatment-related adverse events were observed Although the pilot study was not designed to prove efficacy it suggested positive effects on tremor with improvements sustained for weeks after treatment This extension study aims to further evaluate the long-term safety tolerability and efficacy of peroneal eTNM in PD and ET patients
Detailed Description:
This is a study to investigate the long-term safety and tolerability of home peroneal eTNM delivered by URIS I in subjects with PD or ET The safety tolerability and efficacy of the home-based peroneal eTNM using URIS ITM neurostimulator in the treatment of symptoms related to movement disorders in subjects with PD and ET has been recently investigated in the study NTC06036368 This 6-weeks open-label single-site pilot study enrolled 24 patients with either PD or ET and was completed in April 2024 This pilot study showed that home-based peroneal eTNM was safe and well tolerated by patients No adverse events related to treatment were observed during the study period These data confirm the excellent safety profile of the peroneal eTNM that has been observed in previous studies in the overactive bladder population In addition all patients were able to stimulate themselves at home without assistance Adherence to the treatment was very high reaching well over 90 Although this pilot study was not designed to demonstrate the efficacy of peroneal eTNM due to its pilot nature and the small sample size the observed results suggest noteworthy positive effects on rest postural and kinetic tremor as measured visually by accelerometers and by validated MDS-UPDRS and TETRAS scales Importantly patients reported sustained improvement in tremor throughout the treatment and continuously for several weeks after conclusion of the 6 weeks stimulation period Data obtained at EoS visit 6 weeks after the last stimulation lend support for a long-lasting persistence of the effect Based on these data the present extension study is designed to evaluate the long-term safety tolerability and efficacy of peroneal eTNM in patients with PD and ET The study will use the medical device URIS I which has been assessed for conformity and issued a declaration of conformity This agent will be used for a different indication or on a different group of patients however without any change in the procedure of use The clinical trial will be conducted in accordance with clinical trial plan TS005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None