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Clinical Trials/NCT06196242
NCT06196242
Recruiting
Not Applicable

Research on Lead Localization for Deep Brain Stimulation After Implantation

Tsinghua University1 site in 1 country10 target enrollmentDecember 10, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Tsinghua University
Enrollment
10
Locations
1
Primary Endpoint
Lead position
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Deep brain stimulation (DBS) is an effective treatment for a variety of neurological and psychiatric disorders, with more than 200,000 patients implanted with DBS devices worldwide. Parkinson's disease is one of the typical indications.The clinical outcomes of DBS depends on the accurate implantation of the lead, and the identification of the lead locations is the basis for evaluating the effectiveness of the treatment. The aim of this study is to localize the implantation position of the lead based on postoperative MRI images and to reconstruct the relative spatial relationship between the lead and the stimulation target. By comparing with the lead position identified based on postoperative CT, this study will evaluate the accuracy of identifying the DBS lead position directly from MRI. This study may help to optimise the stimulation parameters and investigate the best stimulation targets for DBS patients.

Registry
clinicaltrials.gov
Start Date
December 10, 2023
End Date
December 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Luming Li

Professor

Tsinghua University

Eligibility Criteria

Inclusion Criteria

  • Parkinson's disease patients with DBS devices, DBS implanted for at least 1 month.
  • Ability to tolerate DBS turn-off for at least 30 minutes.
  • DBS devices do not contain the ferromagnetic material.
  • The patients can fully understand the content of the trial and sign the informed consent form.
  • Able to comply to the requirements of this study.

Exclusion Criteria

  • Presence of other concomitant diseases that have or require implantation of pacemakers, defibrillators, cochlear implants, or other neurostimulation devices.
  • Patients who are abnormally sensitive to temperature or allergic to heat.
  • Patients with severe psychiatric disorders or cognitive impairment.

Outcomes

Primary Outcomes

Lead position

Time Frame: 1 day

The accuracy of the lead localization will be evaluated by the distance between the identified position of the lead electrode and the center of the reconstructed stimulation target. The result of lead localization by CT will be used as the reference.

Study Sites (1)

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