A biomarker for deep brain stimulation efficacy in cervical dystonia
- Conditions
- disorder of muscle tensionDystonia10028037
- Registration Number
- NL-OMON49897
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
In order to participate in this study, CD patients must meet the following
criteria:
• Patients with a clinically confirmed diagnosis of idiopathic CD and age >= 18
years;
• A life expectancy of at least one year after surgery;
• For the patients in the EMG-part: DBS indication approved by the DBS team of
the patients hospital.
The inclusion criteria for the controls are:
• Age- and gender match to the participating patients;
• Life expectancy of at least one year after inclusion in the study;
• Age >= 18 years.
A potential subject who meets any of the following criteria will be excluded
from participation in this study.
CD patients and controls:
• Relevant neurological conditions other than CD;
• Previous brain surgery;
• Impossibility to stop anticholinergic medication;
• Pregnancy or breast feeding;
• Exhibition to a radiation dose for medical research, exceeding the maximum
annual dose;
• Contra-indication for MRI scanning (MR incompatible implants, risk of metal
particles in the eyes, tattoos containing red pigments, sensitivity to contrast
fluid);
• Claustrophobia.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are:<br /><br>- The difference in [18F]FEOBV PET binding between CD patients and controls,<br /><br>and its relation to motor- and NMS.<br /><br>- The difference in intermuscular coherence between CD patients and controls,<br /><br>and its relation to motor- and NMS.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoint of this study is the intermuscular coherence (pre- and<br /><br>post-DBS) and cholinergic binding (only pre-DBS), and whether pre-operative<br /><br>measurements are predictive for the effect of DBS on motor- and NMS. </p><br>