fMRI-guided Transcranial Magnetic Stimulation Treatment for Parkinson's Disease

December 11, 2024 updated by: Changping Laboratory

Study of Multi-Modal Imaging Technology in MRI-Guided Transcranial Magnetic Stimulation Treatment for Parkinson's Disease

The goal of this clinical trial is to compare the efficacy of targeting the newly discovered SCAN versus traditional effector-specific networks in M1 using multimodal imaging and rTMS in patients with Parkinson's disease. The main question it aims to answer is: Is rTMS targeting the SCAN more effective than rTMS targeting effector networks?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Parkinson's disease (PD) is a neurodegenerative disorder commonly affecting middle-aged and elderly individuals. Besides conventional treatments such as medication (e.g., levodopa) and surgery (e.g., deep brain stimulation), non-invasive neuromodulation techniques, such as transcranial magnetic stimulation (TMS), have been widely used as a safe and well-tolerated non-pharmacological adjunct therapy for PD patients. However, the limited efficacy of TMS may be attributed to an incomplete understanding of PD-related cortical circuits and imprecise targeting.

Historically, the primary motor cortex (M1) has been selected as the repetitive TMS (rTMS) target for PD treatment. In 2022, Gordon et al. discovered a new network within the M1 that differs from effector-specific networks responsible for executing movements of specific body parts, such as those for the foot, hand, and face. This newly identified network, named the somato-cognitive action network (SCAN), is located in inter-effector regions and is responsible for motor planning, control, and coordination. Damage to this network correlates with key PD symptoms, making SCAN a promising new target for PD intervention.

This study aims to compare the efficacy of targeting the newly discovered SCAN versus traditional effector-specific networks in M1 using multimodal imaging and Intermittent theta burst stimulation (iTBS), a rapid form of rTMS. The objective is to provide new clinical evidence for non-invasive neuromodulation in Parkinson's disease.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 462000
        • Henan Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of primary PD per the MDS Clinical Diagnostic Criteria (2015) or the Chinese Parkinson's Disease Diagnostic Criteria (2016).
  • Age 18-75.
  • Stable use of anti-PD medication for at least two months prior to enrollment.
  • Normal cognitive function (MMSE > 24).
  • Understanding of the study and signing of informed consent.

Exclusion Criteria:

  • Diagnosed with other neurological diseases, such as stroke, brain tumor, traumatic brain injury, motor neuron disease, Alzheimer's disease, multiple sclerosis, etc.
  • Implanted medical devices incompatible with MRI, such as deep brain stimulators, pacemakers, cochlear implants, or vagus nerve stimulators.
  • Conditions contraindicated for MRI, such as claustrophobia, tattoos, or magnetic metal implants.
  • Personal or family history of epilepsy.
  • Prior neuromodulation treatments (e.g., TMS, transcranial electrical stimulation, transcranial ultrasound stimulation) within the last three months.
  • Other health abnormalities that the investigator deems unsuitable for study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCAN
14-day iTBS on personalized SCAN localized by precision functional mapping
Device: Intermittent theta burst stimulation (iTBS)
iTBS: 90% RMT, 50Hz intraburst frequency, 3 pulses per burst, 5Hz interburst frequency, 2 seconds on/8 seconds off, totaling 1800 pulses over approximately 10 minutes. Each day includes 4 iTBS sessions (1800 pulses per session) with 50-minute intervals, totaling 7200 pulses per day for 14 consecutive days (100800 pulses total).
Active Comparator: Effector
14-day iTBS on personalized effector-specific network localized by precision functional mapping
Device: Intermittent theta burst stimulation (iTBS)
iTBS: 90% RMT, 50Hz intraburst frequency, 3 pulses per burst, 5Hz interburst frequency, 2 seconds on/8 seconds off, totaling 1800 pulses over approximately 10 minutes. Each day includes 4 iTBS sessions (1800 pulses per session) with 50-minute intervals, totaling 7200 pulses per day for 14 consecutive days (100800 pulses total).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDS-UPDRS-III
Time Frame: Baseline, 7 days, 14 days
The primary outcome is the difference in MDS-UPDRS-III scores at the "on" state at day 7 and day 14 after iTBS intervention.
Baseline, 7 days, 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changping Laboratory

Collaborators

Henan Provincial People's Hospital

Investigators

  • Study Chair: Hesheng Liu, PhD, Changping Laboratory

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2023

Primary Completion (Actual)

April 28, 2024

Study Completion (Actual)

May 15, 2024

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDHNTMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified patient data will be available to researchers upon reasonable request by contacting the corresponding authors after the publication of relevant papers.

IPD Sharing Time Frame

after the publication of relevant papers

IPD Sharing Access Criteria

researchers upon reasonable request by contacting the corresponding authors

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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