Advanced Parkinson's DiseaseNCT06396494
An Automated Navigation System for Deep Brain Electrode Implantation
An observational study of Advanced Parkinson's Disease and Refractory Epilepsy, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
1. Analysis of the correlation between imaging and electrophysiological signals. 2. Real time analysis method for optimal implantation position. 3. Simultaneous Imaging and electrophysiology navigation. 4. Accuracy and security verification of navigation system. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Advanced Parkinson's Disease, Refractory Epilepsy, Obsessive-compulsive Disorder
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing subthalamic nucleus or globus pallidus deep brain stimulation surgery at Beijing Tiantan Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Automated Deep Brain Electrode Implantation System Assisted by Simultaneous Imaging and Electrophysiology Navigation
- Analysis of the correlation between imaging and electrophysiological signals.
- Real time analysis method for optimal implantation position.
- Simultaneous Imaging and electrophysiology navigation.
- Accuracy and security verification of navigation system.
Expectation(Hypothesis):
Develop an automated DBS surgical navigation system based on multimodal brain imaging data and neural electro-physiological signals, which can achieve real-time linkage navigation between imaging and electrophysiology, and automatically generate the optimal implantation position of DBS electrodes based on imaging and electrophysiological information through deep learning algorithms, thereby reducing DBS electrode implantation position errors and improving surgical efficacy.
Read the detailed description
Firstly, we choose patients who voluntarily participate in this clinical study and sign an informed consent form, whose age range from 35 to 75 years old, regardless of gender. Their clinical diagnosis is consistent with typical Parkinson's disease or muscle tone disorders, and the medical history is within 20 years. Additionally, their MRI examination excludes obvious structural changes. Last but not least, patients should have basic normal vision and hearing, and good compliance.
Then, we collect general information of enrolled patients, input preoperative MRI images of the head and thin-layer CT scans with a head rest on the surgical day into the system for image processing. Connect this system to the electrophysiological signal acquisition system during DBS surgery and record the electrophysiological signals. The first one is to analyze the degree of matching between the position and length of nuclei displayed by electrophysiological signals and imaging information, and verify the matching of the intraoperative imaging electrophysiological linkage tool. At the same time, compare the position and length information of nuclei prompted by the tool with the judgment of the surgeon, and analyze the differences between it and the judgment of clinical doctors. The second one is to using an automatic analysis tool for electrophysiological signals, record the analysis results, compare the optimal electrode implantation position automatically calculated by the system with the final implantation position selected by the surgeon, calculate the differences between the two, and further analyze the differences with the judgment of clinical doctors.
Finally, This study will test the accuracy and usability of the two tools involved in DBS surgery, and collect the following indicators: 1) the length of nuclei and the position of nucleus boundaries on imaging data, the length of nuclei and the position of nucleus boundaries on electrophysiological data, the matching degree between imaging and electrophysiology, and the consistency of nucleus information interpreted by clinical doctors after imaging electrophysiology integration; 2) Using an automatic analysis tool for electrophysiological signals, record the analysis results, compare the optimal electrode implantation position automatically calculated by the system with the final implantation position selected by the surgeon, calculate the differences between the two, and further analyze the differences with the judgment of clinical doctors.
- Keywords
- deep brain stimulation, imaging-electrophysiology linkage, navigation
- Medical subject headings
- Drug Resistant Epilepsy, Obsessive-Compulsive Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2025.12
Secondary outcomes (1)
The matching of image-electrophysiology linkage tools
Record the boundary of the nucleus (in millimeters) on the imaging data and the boundary of the nucleus (in millimeters) on the electrophysiological data. The difference between these two nuclear information data is calculated as the outcome measures to verify the image-electrophysiological matching.
Measured: 2025.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Jan 2024
- Primary completion18 Mar 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396494
- Sponsor's protocol ID
- YGLX202321
- Status last verified
- May 2024
- First submitted
- 11 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Automated Deep Brain Electrode Implantation System Assisted by Simultaneous Imaging and Electrophysiology Navigation
- ClinicalTrials.gov ID
- NCT06396494
- Acronym / sponsor ID
- YGLX202321
- Keywords
- deep brain stimulation, imaging-electrophysiology linkage, navigation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Analysis of the correlation between imaging and electrophysiological signals.
- Real time analysis method for optimal implantation position.
- Simultaneous Imaging and electrophysiology navigation.
- Accuracy and security verification of navigation system.
Expectation(Hypothesis):
Develop an automated DBS surgical navigation system based on multimodal brain imaging data and neural electro-physiological signals, which can achieve real-time linkage navigation between imaging and electrophysiology, and automatically generate the optimal implantation position of DBS electrodes based on imaging and electrophysiological information through deep learning algorithms, thereby reducing DBS electrode implantation position errors and improving surgical efficacy.
Detailed description
Firstly, we choose patients who voluntarily participate in this clinical study and sign an informed consent form, whose age range from 35 to 75 years old, regardless of gender. Their clinical diagnosis is consistent with typical Parkinson's disease or muscle tone disorders, and the medical history is within 20 years. Additionally, their MRI examination excludes obvious structural changes. Last but not least, patients should have basic normal vision and hearing, and good compliance.
Then, we collect general information of enrolled patients, input preoperative MRI images of the head and thin-layer CT scans with a head rest on the surgical day into the system for image processing. Connect this system to the electrophysiological signal acquisition system during DBS surgery and record the electrophysiological signals. The first one is to analyze the degree of matching between the position and length of nuclei displayed by electrophysiological signals and imaging information, and verify the matching of the intraoperative imaging electrophysiological linkage tool. At the same time, compare the position and length information of nuclei prompted by the tool with the judgment of the surgeon, and analyze the differences between it and the judgment of clinical doctors. The second one is to using an automatic analysis tool for electrophysiological signals, record the analysis results, compare the optimal electrode implantation position automatically calculated by the system with the final implantation position selected by the surgeon, calculate the differences between the two, and further analyze the differences with the judgment of clinical doctors.
Finally, This study will test the accuracy and usability of the two tools involved in DBS surgery, and collect the following indicators: 1) the length of nuclei and the position of nucleus boundaries on imaging data, the length of nuclei and the position of nucleus boundaries on electrophysiological data, the matching degree between imaging and electrophysiology, and the consistency of nucleus information interpreted by clinical doctors after imaging electrophysiology integration; 2) Using an automatic analysis tool for electrophysiological signals, record the analysis results, compare the optimal electrode implantation position automatically calculated by the system with the final implantation position selected by the surgeon, calculate the differences between the two, and further analyze the differences with the judgment of clinical doctors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing subthalamic nucleus or globus pallidus deep brain stimulation surgery at Beijing Tiantan Hospital.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The accuracy of automatic electrode position analysis tools
Time frame: 2025.12
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.
1 secondary outcome
The matching of image-electrophysiology linkage tools
Time frame: 2025.12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Parkinson's Disease and Refractory Epilepsy, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of automatic electrode position analysis tools (time frame: 2025.12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.