Deep Brain Stimulation Lead Localization After Implantation

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Diagnostic Test: MRI and CT scan

• Registration Number: NCT06196242
• Lead Sponsor: Tsinghua University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12-10
• Study First Submitted: 2023-12-25
• Study First Submitted QC: 2023-12-25
• Last Update Submitted: 2023-12-25
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DBS lead localization	MRI and CT scan	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.

Primary Outcome Measures

Name	Time	Method
Lead position	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.

Trial Locations

Locations (1)

National Engineering Research Center of Neuromodulation; 🇨🇳 Beijing, Beijing, China