Correlation of Tractography and Motor Evoked Potentials in Deep Brain Stimulation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Nova Scotia Health Authority
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- distance between stimulation electrode and motor fibers in mm
Study Overview
Brief Summary
The goal is to establish another anatomical referencing system in order to achieve an even higher accuracy when implanting stimulation electrodes.
Detailed Description
The main goal is to find out what are the optimal distances to these reference fiber tracts when stimulating and to find the optimal target. This has to be evaluated for each target, such as globus pallidus (Gpi), subthalamic nucleus (STN) and ventral intermediate nucleus of the thalamus (VIM) separately. This is of special importance as the investigators can demonstrate the internal capsule, which is often a generator of stimulation-induced side effects: tetanic muscle contractions, dysarthria and gaze deviations.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patient qualifying for deep brain stimulation on the basis of a movement disorder (Parkinson's Disease, tremor, dystonia) or chronic pain disease.
- •Informed consent
Exclusion Criteria
- •Lack of consent
- •Electrical or other devices that preclude the performance of an MRI
Outcomes
Primary Outcomes
distance between stimulation electrode and motor fibers in mm
Time Frame: Intraoperative
Distances between the stimulation electrode and motor fibers as depicted on fiber tracking in millimeters in correlation to the threshold current for eliciting clinical side effects
Secondary Outcomes
- Intraoperative intensity of stimulation in milliampere (mA)(Intraoperative)
- Change in disease score units on the TWSTR rating scale(twelve months)
- Stimulation thresholds in milliampere (mA)(Intraoperative)
- Change in disease score units on the BFMDRS rating scale(twelve months)
- Change in disease score units on the PDQ-39 rating scale(twelve months)
- Change in disease score units on the UPDRS rating scale(twelve months)
- Change in disease score units on the FTRS rating scale(twelve months)