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Neuroprotective Effects of iTBS in PD

Neuroprotective Effects of iTBS in PD

Recruiting
20-80 years
All
Phase N/A

Overview

Intermittent theta burst stimulation (iTBS) is an emerging non-invasive neuron regulation technique, which is widely used in neuropsychiatry for a variety of diseases and is widely accepted by patients due to its non-invasive, operable and relatively precise localization. Combining the results of previous studies and our group's previous research, sixty qualified PD patients would be enrolled to conduct a prospective single-center randomized double-blind sham controlled clinical trial to verify the long-term curative effects of iTBS treatment protocol and explore the neuron-protection of iTBS on neuronal loss of PD patients.

Eligibility

Inclusion Criteria:

  • Meet the revised clinical diagnostic criteria for Parkinson's disease of the Movement Disorder Society (MDS) International (2015 version).
  • aged >20 years and <80 years, regardless of gender.
  • 2 ≤ Hoehn-Yahr stage≤ 4.
  • Maintain medication stability during the study period.
  • Good compliance, written informed consent, and consent for long-term interventional treatment with iTBS.

Exclusion Criteria:

  • Patients with severe neuropsychiatric disorders or previous history of severe neurological disorders (e.g., epilepsy, cerebrovascular accidents, etc.) or history of traumatic brain injury or brain surgery.
  • Patients with significant cognitive impairment (MMSE < 24) or inability to complete questionnaires independently.
  • Prior treatment with TMS, DBS or SCS.
  • Severe physical illness and any physical illness that can precipitate epilepsy or intracranial hypertension, including cardiovascular and respiratory disease.
  • Have human implantable materials such as intracranial stents, pacemakers, coronary stents, cochlear implants, etc.
  • Are currently taking other investigational drugs.
  • Any other condition that the investigator deems unsuitable for participation in this study.

Study details
    Neuroprotection
    Parkinson Disease
    Intermittent Theta Burst Stimulation

NCT05445505

Ruijin Hospital

9 March 2024

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