An Automated Navigation System for Deep Brain Electrode Implantation

NCT06396494 | Active Not Recruiting

• 1 other identifier: YGLX202321
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Analysis of the correlation between imaging and electrophysiological signals.
2. 2.Real time analysis method for optimal implantation position.
3. 3.Simultaneous Imaging and electrophysiology navigation.
4. 4.Accuracy and security verification of navigation system.

Conditions

Advanced Parkinson's Disease; Refractory Epilepsy; Obsessive-compulsive Disorder

Keywords

deep brain stimulation; imaging-electrophysiology linkage; navigation

Outcome Measures

Primary Outcomes (1)

• The accuracy of automatic electrode position analysis tools

  The best placement of the electrode (indicated by coordinates) is compared with the final placement of the implant selected by the surgeon (indicated by coordinates), then the difference between the two is calculated in millimeters as the outcome measures.

  2025.12

Secondary Outcomes (1)

• The matching of image-electrophysiology linkage tools

  2025.12

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing subthalamic nucleus or globus pallidus deep brain stimulation surgery at Beijing Tiantan Hospital.

You may qualify if:

• Clinical diagnosis is consistent with typical Parkinson's disease or dystonia, and the medical history is within 20 years;
• MRI examination excludes obvious structural changes.

You may not qualify if:

• Severe mental, cognitive, or psychological disorders ;
• Contraindications to neurosurgery, such as hydrocephalus, brain atrophy, sequelae of cerebrovascular disease, heart disease, etc. Cardiovascular and cerebrovascular diseases;
• The presence of tumors, severe abnormalities in liver and kidney function (indicators more than 3 times normal) and other concomitant diseases that seriously affect health;
• The presence of intracranial mass, cerebrovascular disease, mental illness, and other neurological diseases , claustrophobia or implants in the body that affect MRI scans.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100071, China

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Anxiety Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: May 2, 2024
• Study Start: January 1, 2024
• Primary Completion: March 18, 2024
• Study Completion: December 31, 2025
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)