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Clinical Trials/NCT06734676
NCT06734676
Completed
N/A

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

Changping Laboratory1 site in 1 country36 target enrollmentMay 29, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
Changping Laboratory
Enrollment
36
Locations
1
Primary Endpoint
MDS-UPDRS-III
Status
Completed
Last Updated
last year

Overview

Brief Summary

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?

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.

Registry
clinicaltrials.gov
Start Date
May 29, 2023
End Date
May 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Changping Laboratory
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of primary PD per the MDS Clinical Diagnostic Criteria (2015) or the Chinese Parkinson's Disease Diagnostic Criteria (2016).
  • 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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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