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

NCT06734676 | Completed

• 1 other identifier: PDHNTMS
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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?

Conditions

Parkinson's Disease

Keywords

TMS; Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• MDS-UPDRS-III

  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

Study Arms (2)

SCAN

EXPERIMENTAL

14-day iTBS on personalized SCAN localized by precision functional mapping

Device: Intermittent theta burst stimulation (iTBS)

Effector

ACTIVE COMPARATOR

14-day iTBS on personalized effector-specific network localized by precision functional mapping

Device: Intermittent theta burst stimulation (iTBS)

Interventions

Intermittent theta burst stimulation (iTBS) DEVICE

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).

Effector; SCAN

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changping Laboratory: lead
• Henan Provincial People's Hospital: collaborator

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 462000, China

Location

Related Publications (3)

• Gordon EM, Chauvin RJ, Van AN, Rajesh A, Nielsen A, Newbold DJ, Lynch CJ, Seider NA, Krimmel SR, Scheidter KM, Monk J, Miller RL, Metoki A, Montez DF, Zheng A, Elbau I, Madison T, Nishino T, Myers MJ, Kaplan S, Badke D'Andrea C, Demeter DV, Feigelis M, Ramirez JSB, Xu T, Barch DM, Smyser CD, Rogers CE, Zimmermann J, Botteron KN, Pruett JR, Willie JT, Brunner P, Shimony JS, Kay BP, Marek S, Norris SA, Gratton C, Sylvester CM, Power JD, Liston C, Greene DJ, Roland JL, Petersen SE, Raichle ME, Laumann TO, Fair DA, Dosenbach NUF. A somato-cognitive action network alternates with effector regions in motor cortex. Nature. 2023 May;617(7960):351-359. doi: 10.1038/s41586-023-05964-2. Epub 2023 Apr 19.

  PMID: 37076628 BACKGROUND

• Latorre A, Rocchi L, Berardelli A, Bhatia KP, Rothwell JC. The use of transcranial magnetic stimulation as a treatment for movement disorders: A critical review. Mov Disord. 2019 Jun;34(6):769-782. doi: 10.1002/mds.27705. Epub 2019 Apr 29.

  PMID: 31034682 BACKGROUND

• Zhang W, Deng B, Xie F, Zhou H, Guo JF, Jiang H, Sim A, Tang B, Wang Q. Efficacy of repetitive transcranial magnetic stimulation in Parkinson's disease: A systematic review and meta-analysis of randomised controlled trials. EClinicalMedicine. 2022 Jul 29;52:101589. doi: 10.1016/j.eclinm.2022.101589. eCollection 2022 Oct.

  PMID: 35923424 BACKGROUND

Study Officials

• Hesheng Liu, PhD

  Changping Laboratory

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: May 29, 2023
• Primary Completion: April 28, 2024
• Study Completion: May 15, 2024
• Last Updated: December 16, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: after the publication of relevant papers
• Access Criteria: researchers upon reasonable request by contacting the corresponding authors

Locations

CN (1)