Neuroprotective Effects of iTBS in PD

Not Applicable

Recruiting

• Conditions: Parkinson Disease; Neuroprotection; Intermittent Theta Burst Stimulation

• Registration Number: NCT05445505
• Lead Sponsor: Ruijin Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-06-30
• Study First Posted: 2022-07-06
• Study Start: 2022-08-01
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Group differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes	28 weeks	Compare the changes in UPDRS scores from baseline to post-iTBS in the four intervention groups (UPDRS part3: range 0\~72, higher score is related to a worse outcome).

Secondary Outcome Measures

Name	Time	Method
Group differences of Hamilton Anxiety Scale (HAMA) changes	28 weeks	Compare the changes in HAMA scores from baseline to post-iTBS in the four intervention groups (HAMA: range 0\~64, higher score is related to a worse outcome).
Group differences of Wexner changes	28 weeks	Compare the changes in Wexner scores from baseline to post-iTBS in the four intervention groups (Wexner: range 0\~30, higher score is related to a worse outcome).
Group differences of Hamilton depression scale-17 (HAMD-17) changes	28 weeks	Compare the changes in HAMD-17 scores from baseline to post-iTBS in the four intervention groups (HAMD-17: range 0\~38, higher score is related to a worse outcome).
Group differences of Mini-mental State Examination (MMSE) changes	28 weeks	Compare the changes in MMSE scores from baseline to post-iTBS in the four intervention groups (MMSE: range 0\~30, higher score is related to a better outcome).
Group differences of adverse event	28 weeks	Compare the adverse event in four intervention groups.
Group differences of Hoehn-Yahr stage	28 weeks	Compare the changes in Hoehn-Yahr stage from baseline to post-iTBS in the four intervention groups (H-Y stage: range 0\~5, higher score is related to a worse outcome).
Group differences of 16-item Sniffin' Sticks test (SS-16) changes	28 weeks	Compare the changes in SS-16 scores from baseline to post-iTBS in the four intervention groups (SS-16: range 0\~16, higher score is related to a better outcome).
Group differences of Montreal Cognitive Assessment (MoCA) changes	28 weeks	Compare the changes in MoCA scores from baseline to post-iTBS in the four intervention groups (MoCA: range 0\~30, higher score is related to a better outcome).
Group differences of Berg Balance Scale (BBS) changes	28 weeks	Compare the changes in BBS scores from baseline to post-iTBS in the four intervention groups (BBS: range 0\~56, higher score is related to a better outcome).
Group differences of 39-item Parkinson's Disease Questionnaire (PDQ-39) changes	28 weeks	Compare the changes in PDQ-39 scores from baseline to post-iTBS in the four intervention groups (PDQ-39: range 0\~156, higher score is related to a worse outcome).

Trial Locations

Locations (1)

Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China