Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-03-08 @ 1:50 AM
Study NCT ID:
NCT02823158
Status:
TERMINATED
Last Update Posted:
2019-10-22
First Post:
2016-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease-LATESTIM
Sponsor:
Insel Gruppe AG, University Hospital Bern
Organization:
Study Overview
Official Title:
A Prospective Randomized Controlled Trial of Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease With Motor Complications and Relative or Absolute Contraindications for Subthalamic Stimulation
Status:
TERMINATED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
not enough patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LATESTIM
Brief Summary:
Deep brain stimulation (DBS) is an established treatment for advanced complicated Parkinson's disease (PD). Several controlled randomized studies have given proof of an advantage for operated patients as compared to medically treated patients in terms of motor outcome, activities of daily living and health status. However these studies have addressed mostly stimulation of the subthalamic nucleus (STN). GPi stimulation has not been compared to best medical treatment (BMT) in a prospective randomized controlled trial in patients with complicated PD who are not good candidates for STN stimulation. The investigators aim assessing GPi-DBS in patients with PD who have contraindications for STN-DBS.
Detailed Description:
The indication and excellent therapeutic effects of STN stimulation have been sufficiently proven in advanced PD, and the contraindications for this treatment are rather well established. Also, the observation that patients fulfilling the "STN-profile" but who had been operated for pallidal DBS and lost part of the treatment's benefit over time, improved when stimulated later in the STN (instead of the GPi) shows that patients qualifying for STN-DBS do not have as good a result with GPi-DBS.
GPi stimulation may be used in patients who do not qualify for STN stimulation. Especially postural instability, age over 70 years, and mild to moderate cognitive deficits are commonly considered to be exclusion criteria for STN stimulation but not for GPi stimulation. Therefore, the investigators propose a prospective randomized controlled trial of GPi stimulation in patients with PD and motor complications who have relative or absolute contraindications for STN stimulation.
GPi stimulation may be used in patients who do not qualify for STN stimulation. Especially postural instability, age over 70 years, and mild to moderate cognitive deficits are commonly considered to be exclusion criteria for STN stimulation but not for GPi stimulation. Therefore, the investigators propose a prospective randomized controlled trial of GPi stimulation in patients with PD and motor complications who have relative or absolute contraindications for STN stimulation.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: