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.

Study Overview

• Status: Recruiting
• Conditions: Improving Accuracy of Implanting Stimulation Electrodes
• Intervention / Treatment: Procedure: Deep Brain Stimulation

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Lutz Weise, MD; Phone Number: 902-473-6850; Email: lutz.weise@nshealth.ca

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H3A7
      • Recruiting
      • Queen Elizabeth Health Science Centre
      • Contact: Lutz Weise, MD; Phone Number: 902-473-6850; Email: lutz.weise@nshealth.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients who qualify for deep brain stimulation on the basis of a movement disorder and chronic pain

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Intraoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Lutz Weise, MD, Dalhousie University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DBS2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No