Deep Brain Stimulation Lead Localization After Implantation

NCT06196242 | Unknown

• 1 other identifier: LeadLocMRI
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Deep Brain Stimulation; Lead Localization; MRI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

DBS lead localization

EXPERIMENTAL

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.

Diagnostic Test: MRI and CT scan

Interventions

MRI and CT scan 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.

DBS lead localization

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tsinghua University: lead

Study Sites (1)

National Engineering Research Center of Neuromodulation

Beijing, Beijing Municipality, 100084, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Magnetic Resonance Imaging; Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray

Central Study Contacts

Feng Zhang, Ph.D.

CONTACT

86-010-62794952; zhang-f@mail.tsinghua.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 9, 2024
• Study Start: December 10, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)