Deep Brain Stimulation of the Nucleus Basalis of Meynert in patients with Parkinson's Disease

Withdrawn

Conditions: Parkinson's
Parkinson's disease
10028037
10012272

Registration Number: NL-OMON45897

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 11

Inclusion Criteria

1. Patient with GPi stimulation, with the NBM in reach of the electric field at least one DBS electrode
2. Patients should be able to give informed consent
3. patients should be on a stable medication regimen for at least 4 weeks

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study if any unstable internal disease is found.
Additional exclusion criteria is made to determine whether or not a subject can continue to the crossover trial. Subject with significant worsening of motor function during the screening trial, which is indicated by an increase of the UPDRS part III score more than 30%, will not continue to the crossover trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> The primary measure of this study is the cognitive performance of the<br /><br>subjects, assessed by the symbol digit modality test (SDMT), the Vienna test<br /><br>system (VTS) - Attention, and the verbal fluency test.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(1) The measure of resting cortical activity performed by<br /><br>electroencephalography (EEG) at baseline and weekly at the end of each period<br /><br>of crossover trial<br /><br>(2) Assessment of motor function. The Unified Parkinson*s Disease Rating Scale<br /><br>(UPDRS) part III (motor examination) and part IV (motor complication) will be<br /><br>performed at the beginning of the screening trial before adjusting the DBS<br /><br>setting, and at the end of the three-day screening trial of the NBM-DBS.<br /><br>(3) Safety and tolerability of the low-frequency stimulation of the NBM in this<br /><br>study is defined as any adverse effects associated with the adjustment of the<br /><br>DBS setting during the screening phase as well as in the crossover phase.</p><br>