Deep Brain Stimulation Lead Localization After Implantation

NCT ID: NCT06196242

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-10
• Study Completion Date: 2025-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

DBS lead localization

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.

Group Type: EXPERIMENTAL

MRI and CT scan

Intervention Type: DIAGNOSTIC_TEST

An MRI scan of the head in about 30 minutes. During the scan, MRI thermometry will be performed to monitor for possible lead heating due to the interaction of the MRI radiofrequency field and the implanted devices.

An CT plain scan of the head in about 10 minutes.

Interventions

MRI and CT scan

An MRI scan of the head in about 30 minutes. During the scan, MRI thermometry will be performed to monitor for possible lead heating due to the interaction of the MRI radiofrequency field and the implanted devices.

An CT plain scan of the head in about 10 minutes.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tsinghua University

OTHER

Sponsor Role: lead

Responsible Party

Luming Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Engineering Research Center of Neuromodulation

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Feng Zhang, Ph.D.

Role: CONTACT

zhang-f@mail.tsinghua.edu.cn

86-010-62794952

Facility Contacts

Feng Zhang, Ph.D.

Role: primary

zhang-f@mail.tsinghua.edu.cn

86-010-62794952

Other Identifiers

LeadLocMRI

Identifier Type: -

Identifier Source: org_study_id