Deep Brain Stimulation Lead Localization After Implantation

Tsinghua University

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Diagnostic Test: MRI and CT scan

Study type: Interventional

Funder types: Other

Identifiers

NCT06196242

LeadLocMRI

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

DBS lead localization

Experimental group

Description:

Participates will receive a head MRI anc CT scan. The stimulation target and the related neural nuclei will be reconstructed using MRI images. The spatial position of the implanted lead will be identified with MRI and CT. Through comparing with the identified lead position by CT, the accuracy of lead localization by MRI will be evaluated.

Treatment:

Diagnostic Test: MRI and CT scan