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Correlation of Tractography and Motor Evoked Potentials in Deep Brain Stimulation

Correlation of Tractography and Motor Evoked Potentials in Deep Brain Stimulation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03136302
Enrollment
60
Registered
2017-05-02
Start date
2017-09-01
Completion date
2025-09-01
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improving Accuracy of Implanting Stimulation Electrodes

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.

Interventions

PROCEDUREDeep Brain Stimulation

Deep Brain Stimulation

Sponsors

Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
distance between stimulation electrode and motor fibers in mmIntraoperativeDistances 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

MeasureTime frameDescription
Stimulation thresholds in milliampere (mA)IntraoperativeThreshold of intraoperative stimulation intensity in milliamp, which elicits capsular side effects
Change in disease score units on the UPDRS rating scaletwelve monthsAssessment of therapeutic effects using Unified Parkinson disease rating scale (UPDRS)
Change in disease score units on the FTRS rating scaletwelve monthsAssessment of therapeutic effects using, Fahn-Tremor Rating Scale (FTRS)
Intraoperative intensity of stimulation in milliampere (mA)IntraoperativeIntraoperative intensity of stimulation in milliamp, which elicits an activation of contralateral muscle groups (musculus interosseus dorsalis and the musculus tibialis anterior)
Change in disease score units on the TWSTR rating scaletwelve monthsAssessment of therapeutic effects using Toronto Western Spasmodic torticollis rating scale (TWSTR)
Change in disease score units on the PDQ-39 rating scaletwelve monthsAssessment of therapeutic effects using Parkinsons Disease QuestionnairePDQ-39
Change in disease score units on the BFMDRS rating scaletwelve monthsAssessment of therapeutic effects using Burke-Fahn-Marsden dystonia rating scale (BFMDRS)

Countries

Canada

Contacts

Primary ContactLutz Weise, MD
lutz.weise@nshealth.ca902-473-6850

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026