Correlation of Tractography and Motor Evoked Potentials in Deep Brain Stimulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deep Brain Stimulation.
- Who it may be relevant to
- Registry conditions: Improving Accuracy of Implanting Stimulation Electrodes. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Deep Brain Stimulation
Deep Brain Stimulation
Primary outcome measures
- distance between stimulation electrode and motor fibers in mm [Time frame: Intraoperative]
Secondary outcome measures (7)
- Intraoperative intensity of stimulation in milliampere (mA) [Time frame: Intraoperative]
- Stimulation thresholds in milliampere (mA) [Time frame: Intraoperative]
- Change in disease score units on the UPDRS rating scale [Time frame: twelve months]
- Change in disease score units on the FTRS rating scale [Time frame: twelve months]
- Change in disease score units on the BFMDRS rating scale [Time frame: twelve months]
- Change in disease score units on the TWSTR rating scale [Time frame: twelve months]
- Change in disease score units on the PDQ-39 rating scale [Time frame: twelve months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
Canada · 1 center
- Queen Elizabeth Health Science Centre — Halifax
Identifiers
NCT: NCT03136302 · DBS2017