Deep Brain Stimulation Lead Localization After Implantation

Parkinson Disease Clinical Trial

Official title:

Research on Lead Localization for Deep Brain Stimulation After Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06196242
• Other study ID #: LeadLocMRI
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Tsinghua University
• Contact: Feng Zhang, Ph.D.
• Phone: 86-010-62794952
• Email: zhang-f[@]mail.tsinghua.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
China	National Engineering Research Center of Neuromodulation	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Tsinghua University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lead position	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.	1 day