An observational study in Improving Accuracy of Implanting Stimulation Electrodes, sponsored by Nova Scotia Health Authority. Recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Nova Scotia Health Authority · Observational
The goal is to establish another anatomical referencing system in order to achieve an even higher accuracy when implanting stimulation electrodes.
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.
Nova Scotia Health Authority is the lead sponsor of 255 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who qualify for deep brain stimulation on the basis of a movement disorder and chronic pain
Exclusion Criteria:
Patients with Parkinson's disease
Procedure: Deep Brain Stimulation
Patients with Dystonia
Procedure: Deep Brain Stimulation
Patients with Tremor
Procedure: Deep Brain Stimulation
Deep Brain Stimulation
distance between stimulation electrode and motor fibers in mm
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
Time frame: Intraoperative
Intraoperative intensity of stimulation in milliampere (mA)
Intraoperative intensity of stimulation in milliamp, which elicits an activation of contralateral muscle groups (musculus interosseus dorsalis and the musculus tibialis anterior)
Time frame: Intraoperative
Stimulation thresholds in milliampere (mA)
Threshold of intraoperative stimulation intensity in milliamp, which elicits capsular side effects
Time frame: Intraoperative
Change in disease score units on the UPDRS rating scale
Assessment of therapeutic effects using Unified Parkinson disease rating scale (UPDRS)
Time frame: twelve months
Change in disease score units on the FTRS rating scale
Assessment of therapeutic effects using, Fahn-Tremor Rating Scale (FTRS)
Time frame: twelve months
Change in disease score units on the BFMDRS rating scale
Assessment of therapeutic effects using Burke-Fahn-Marsden dystonia rating scale (BFMDRS)
Time frame: twelve months
Change in disease score units on the TWSTR rating scale
Assessment of therapeutic effects using Toronto Western Spasmodic torticollis rating scale (TWSTR)
Time frame: twelve months
Change in disease score units on the PDQ-39 rating scale
Assessment of therapeutic effects using Parkinsons Disease QuestionnairePDQ-39
Time frame: twelve months
Plan to share: Undecided
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Nova Scotia Health Authority