fMRI-guided Transcranial Magnetic Stimulation Treatment for Parkinson's Disease
NCT ID: NCT06734676
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2023-05-29
2024-05-15
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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SCAN
14-day iTBS on personalized SCAN localized by precision functional mapping
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).
Effector
14-day iTBS on personalized effector-specific network localized by precision functional mapping
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Henan Provincial People's Hospital
OTHER
Changping Laboratory
OTHER
Responsible Party
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Principal Investigators
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Hesheng Liu, PhD
Role: STUDY_CHAIR
Changping Laboratory
Locations
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Henan Provincial People's Hospital
Zhengzhou, Henan, China
Countries
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References
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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.
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.
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.
Other Identifiers
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PDHNTMS
Identifier Type: -
Identifier Source: org_study_id