Correlation of Tractography and Motor Evoked Potentials in Deep Brain Stimulation

Recruiting

• Conditions: Improving Accuracy of Implanting Stimulation Electrodes
• Interventions: Procedure: Deep Brain Stimulation

• Registration Number: NCT03136302
• Lead Sponsor: Nova Scotia Health Authority

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 Timeline

• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-05-02
• Study Start: 2017-09-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Globus Pallidus (Gpi)	Deep Brain Stimulation	Patients with Dystonia
Ventral intermediate nucleus of the thalamus (VIM)	Deep Brain Stimulation	Patients with Tremor
Subthalamic Nucleus (STN)	Deep Brain Stimulation	Patients with Parkinson's disease

Primary Outcome Measures

Name	Time	Method
distance between stimulation electrode and motor fibers in mm	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 Outcome Measures

Name	Time	Method
Intraoperative intensity of stimulation in milliampere (mA)	Intraoperative	Intraoperative 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 scale	twelve months	Assessment of therapeutic effects using Toronto Western Spasmodic torticollis rating scale (TWSTR)
Stimulation thresholds in milliampere (mA)	Intraoperative	Threshold of intraoperative stimulation intensity in milliamp, which elicits capsular side effects
Change in disease score units on the BFMDRS rating scale	twelve months	Assessment of therapeutic effects using Burke-Fahn-Marsden dystonia rating scale (BFMDRS)
Change in disease score units on the PDQ-39 rating scale	twelve months	Assessment of therapeutic effects using Parkinsons Disease QuestionnairePDQ-39
Change in disease score units on the UPDRS rating scale	twelve months	Assessment of therapeutic effects using Unified Parkinson disease rating scale (UPDRS)
Change in disease score units on the FTRS rating scale	twelve months	Assessment of therapeutic effects using, Fahn-Tremor Rating Scale (FTRS)

Trial Locations

Locations (1)

Queen Elizabeth Health Science Centre; 🇨🇦 Halifax, Nova Scotia, Canada