Neuroprotective Effects of iTBS in PD
- Conditions
- Parkinson DiseaseNeuroprotectionIntermittent Theta Burst Stimulation
- Interventions
- Device: intermittent theta burst stimulationDevice: sham iTBS
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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
- Arm && Interventions
Group Intervention Description Delayed-start single iTBS group sham iTBS The intensive period: sham/iTBS, 2 weeks The maintenance period: daily sham/iTBS, 12 weeks Early-start single iTBS group intermittent theta burst stimulation The intensive period: 2 weeks The maintenance period: 12 weeks Delayed-start single iTBS group intermittent theta burst stimulation The intensive period: sham/iTBS, 2 weeks The maintenance period: daily sham/iTBS, 12 weeks Delayed-start double iTBS group intermittent theta burst stimulation The intensive period: sham/iTBS, 2 weeks The maintenance period: twice daily sham/iTBS, 12 weeks Delayed-start double iTBS group sham iTBS The intensive period: sham/iTBS, 2 weeks The maintenance period: twice daily sham/iTBS, 12 weeks Early-start double iTBS group intermittent theta burst stimulation The intensive period: 2 weeks The maintenance period: 12 weeks
- 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