Queen Elizabeth Health Science Centre
Halifax, Nova Scotia, B3H3A7, Canada
Location status: Recruiting
Recruiting
NCT Number: NCT03136302
Correlation of Tractography and Motor Evoked Potentials in Deep Brain Stimulation
The goal is to establish another anatomical referencing system in order to achieve an even higher accuracy when implanting stimulation electrodes.
Recruiting
Interested in participating?
Request InfoKey information
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Deep Brain Stimulation
ProcedureDeep Brain Stimulation
Primary outcomes
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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
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Intraoperative intensity of stimulation in milliampere (mA)
Time frame: Intraoperative
Intraoperative intensity of stimulation in milliamp, which elicits an activation of contralateral muscle groups (musculus interosseus dorsalis and the musculus tibialis anterior)
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Stimulation thresholds in milliampere (mA)
Time frame: Intraoperative
Threshold of intraoperative stimulation intensity in milliamp, which elicits capsular side effects
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Change in disease score units on the UPDRS rating scale
Time frame: twelve months
Assessment of therapeutic effects using Unified Parkinson disease rating scale (UPDRS)
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Change in disease score units on the FTRS rating scale
Time frame: twelve months
Assessment of therapeutic effects using, Fahn-Tremor Rating Scale (FTRS)
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Change in disease score units on the BFMDRS rating scale
Time frame: twelve months
Assessment of therapeutic effects using Burke-Fahn-Marsden dystonia rating scale (BFMDRS)
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Change in disease score units on the TWSTR rating scale
Time frame: twelve months
Assessment of therapeutic effects using Toronto Western Spasmodic torticollis rating scale (TWSTR)
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Change in disease score units on the PDQ-39 rating scale
Time frame: twelve months
Assessment of therapeutic effects using Parkinsons Disease QuestionnairePDQ-39
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Nova Scotia Health Authority
Other
Registry information
Important dates
- Study start
- 2017
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- May 2, 2017
- Registry last updated
- Aug 21, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.