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Parkinson's Disease (PD)Microlesion EfNCT06685510

The Relation Between the Prognosis of Subthalamic Nucleus Deep Brain Stimulation Surgery by Microlesion Effect and Electrode Position

An observational study of Parkinson's Disease (PD) and Deep Brain Stimulation, run by Second Affiliated Hospital of Nanchang University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

BACKGROUND: Parkinson's disease (PD) is a common movement disorder whose main symptoms include resting tremor, rigidity and bradykinesia. Deep Brain Stimulation (DBS) has become one of the most effective treatments for PD by implanting electrodes in specific deep brain nuclei to alleviate motor symptoms in PD… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
the score of UPDRS item
How many people
100 participants
Where
1 siteChina
Study dates
6 Nov 2023to 1 Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Idiopathic Parkinson's disease patients who consecutively consulted the Second Affiliated Hospital of Nanchang University's PD-specialized outpatient clinic were collected as the subjects.

Who may be able to join

  • Idiopathic Parkinson Disease
  • Age from 18 to 80 years old
  • Performed bilateral STN-DBS

Who cannot join

  • Does not meet STN-DBS surgical criteria
  • Patients with severely offset electrode implantation position (imaging)
  • Not fulfilling the criteria for an arbitrary cohort under exposure conditions;
  • Patients who are unable to voluntarily sign an informed consent form;
  • Patients who do not agree to cooperate with follow-up visits

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

Other trials in China

About this study

BACKGROUND: Parkinson's disease (PD) is a common movement disorder whose main symptoms include resting tremor, rigidity and bradykinesia. Deep Brain Stimulation (DBS) has become one of the most effective treatments for PD by implanting electrodes in specific deep brain nuclei to alleviate motor symptoms in PD patients. During the implantation of electrodes in the DBS procedure, small lesions produced are known as the Microlesion Effect, which disappears within a short period. The MLE efficacy is positively correlated with the overall efficacy of DBS, but whether the MLE efficacy is affected by the symptoms has not yet been investigated, and a large-sample study is needed to further validate this. This study aims to examine the relationship between electrode implantation location and the prediction of MLE efficacy produced by STN-DBS surgery in PD patients, assess the correlation between electrode implantation location and DBS efficacy in PD patients, and analyze the role of brain networks in the process. The study will also analyze the relationship between micro-destructive effects and long-term DBS efficacy, providing more effective efficacy prediction and a more accurate selection of electrode implantation locations for DBS treatment in PD patients. This study will guide the clinical practice of DBS treatment in PD patients and provide an important reference for future research in related fields.

Object: Primary Parkinson's Disease patients between the ages of 18 and 75 years who meet STN-DBS surgery criteria Aim: To observe the relationship between predicted efficacy and implantation location of STN-DBS for MLE in PD surgery

Being tested
the score of UPDRS item
Keywords
Parkinson's disease, Microlesion Effect, Functional Neuroimages, Deep Brain Stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • the score of UPDRS itemOther

    The score of MDS-UPDRS item 3.1 greater or equal to 2 during the drug-off period at baseline

  • the score of UPDRS itemOther

    The score of MDS-UPDRS item 3.3 greater or equal to 2 during the drug-off period at baseline

  • the score of UPDRS itemOther

    The score of MDS-UPDRS item 3.10 greater or equal to 2 during the drug-off period at baseline

  • the score of UPDRS itemOther

    Any one of the MDS UPDRS 3.15-3.17 scores greater or equal to 2 during the drug-off period at baseline

  • the score of UPDRS itemOther

    Sum of MDS UPDRS 4.1-4.2 scores greater than or equal to 3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparing MLE and DBS efficacy

    Based on the improvement rate of short-term postoperative MDS UPDRS-III scores compared with baseline MDS UPDRS-III scores, three subgroups were divided within each cohort into the <20% group, the 20%-40% group, and the >40% group. General statistical analyses of MDS UPDRS-III scores were performed for each subgroup within each cohort, and the mean and standard deviation were calculated. Pearson correlation coefficient analysis was performed on the MDS UPDRS-III score data. Data on MDS UPDRS-III scores of different subgroups within different cohorts were normalized to include short-term postoperative MDS UPDRS-III scores as an independent variable and postoperative post-start-up MDS UPDRS-III scores as a dependent variable, and to include baseline period, postoperative post-start-up, postoperative 6-months, and 12-months MDS UPDRS-III score as a covariate, ANCOVA was performed to observe the differences and correlations of each data node.

    Measured: From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery

Secondary outcomes (3)

  1. Comparison of the efficacy of electrode positions in relation to different positions of the nucleus pulposus

    Electrode position reconstruction was performed on all subject imaging data. Improvement rates and mean improvement rates were calculated for MDS UPDRS-III scores in the short-term postoperative period, after postoperative start-up, and at 6 and 12 months postoperatively compared to baseline. MLE regional analyses were performed for each subgroup within each cohort, electrode position efficacy heat maps were calculated, and the heat maps were qualitatively analyzed to discuss the relationship between electrode position and efficacy.

    Measured: From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery

  2. Compare short-term postoperative efficacy with postoperative efficacy after start-up

    Improvement rates within the cohort were calculated and analyzed with general statistics for short-term postoperative, postoperative boot-up, and postoperative 6-month and 12-month comparisons of baseline MDS UPDRS-III scores, and the mean and standard deviation of the improvement rates within the cohort for postoperative boot-up, and postoperative 6-month and 12-month comparisons of baseline PDQ-39 scores were calculated. Differences in improvement rate mean at each time point within the cohort were compared, and linear regression analyses of improvement rates were performed to qualitatively analyze the relationship between short-term postoperative outcomes and long-term postoperative outcomes after postoperative start-up and postoperatively.

    Measured: From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery

  3. Compare the difference in the rate of improvement in MDS UPDRS-III scores within the postoperative pre-opening period

    General statistical analyses of MDS UPDRS-III scores within the cohort, subgroups within the cohort, and subgroups within the subgroups and improvement rates compared to baseline were performed to compare the differences in data between cohorts, subgroups, and subgroups within the cohort, and Pearson's correlation analysis, analysis of variance (ANOVA), and qualitative analyses were used to look at the efficacy of postoperative MLE.

    Measured: From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start6 Nov 2023
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06685510
Sponsor's protocol ID
LC23DBSIIT-HW02
Acronym
Microlesion Ef
Status last verified
Nov 2024
First submitted
10 Nov 2024
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liang L, Zhao J, Wang H, Chen L, Shi Q, Yang X, Ma H, Zhu Y, Li Z, Huang W. The microlesion effect is associated with global cognitive impairment and predicts motor outcomes after subthalamic deep brain stimulation in Parkinson's disease. J Neurol. 2025 Oct 18;272(11):708. doi: 10.1007/s00415-025-13443-z.

    PubMed 41109904

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson&#39;s Disease (PD) and Deep Brain Stimulation, run by Second Affiliated Hospital of Nanchang University 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 3 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 12 Nov 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?

This study is still under way. Results are not available in the source record yet.

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?

Comparing MLE and DBS efficacy (time frame: From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06685510, which also lists 1 linked publication.

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 12 Nov 2024.

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