Correlation of Tractography and Motor Evoked Potentials in Deep Brain Stimulation

Sponsor
Lutz Weise (Other)
Overall Status
Unknown status
CT.gov ID
NCT03136302
Collaborator
(none)
60
1
36
1.7

Study Details

Study Description

Brief Summary

The goal is to establish another anatomical referencing system in order to achieve an even higher accuracy when implanting stimulation electrodes.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Correlation of Tractography and Motor Evoked Potentials in Deep Brain Stimulation
Actual Study Start Date :
Sep 1, 2017
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Sep 1, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. Stimulation thresholds in milliampere (mA) [Intraoperative]

    Threshold of intraoperative stimulation intensity in milliamp, which elicits capsular side effects

  3. Change in disease score units on the UPDRS rating scale [twelve months]

    Assessment of therapeutic effects using Unified Parkinson disease rating scale (UPDRS)

  4. Change in disease score units on the FTRS rating scale [twelve months]

    Assessment of therapeutic effects using, Fahn-Tremor Rating Scale (FTRS)

  5. Change in disease score units on the BFMDRS rating scale [twelve months]

    Assessment of therapeutic effects using Burke-Fahn-Marsden dystonia rating scale (BFMDRS)

  6. Change in disease score units on the TWSTR rating scale [twelve months]

    Assessment of therapeutic effects using Toronto Western Spasmodic torticollis rating scale (TWSTR)

  7. Change in disease score units on the PDQ-39 rating scale [twelve months]

    Assessment of therapeutic effects using Parkinsons Disease QuestionnairePDQ-39

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen Elizabeth Health Science Centre Halifax Nova Scotia Canada B3H3A7

Sponsors and Collaborators

  • Lutz Weise

Investigators

  • Principal Investigator: Lutz Weise, MD, Dalhousie University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lutz Weise, Neurosurgery, Head of Neuromodulation, Associate Professor, Nova Scotia Health Authority
ClinicalTrials.gov Identifier:
NCT03136302
Other Study ID Numbers:
  • DBS2017
First Posted:
May 2, 2017
Last Update Posted:
Aug 8, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 8, 2019