Neuroprotective Effects of iTBS in PD
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Early-start single iTBS group The intensive period: 2 weeks The maintenance period: 12 weeks |
Device: intermittent theta burst stimulation
iTBS is a new form of excitatory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session.
Other Names:
|
| Active Comparator: Early-start double iTBS group The intensive period: 2 weeks The maintenance period: 12 weeks |
Device: intermittent theta burst stimulation
iTBS is a new form of excitatory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session.
Other Names:
|
| Sham Comparator: Delayed-start single iTBS group The intensive period: sham/iTBS, 2 weeks The maintenance period: daily sham/iTBS, 12 weeks |
Device: intermittent theta burst stimulation
iTBS is a new form of excitatory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session.
Other Names:
Device: sham iTBS
The pseudo-stimulation device looks and sounds the same as the iTBS device
|
| Sham Comparator: Delayed-start double iTBS group The intensive period: sham/iTBS, 2 weeks The maintenance period: twice daily sham/iTBS, 12 weeks |
Device: intermittent theta burst stimulation
iTBS is a new form of excitatory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session.
Other Names:
Device: sham iTBS
The pseudo-stimulation device looks and sounds the same as the iTBS device
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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 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 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 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 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).
- 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 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 adverse event [28 weeks]
Compare the adverse event in four intervention groups.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Meet the revised clinical diagnostic criteria for Parkinson's disease of the Movement Disorder Society (MDS) International (2015 version).
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aged >20 years and <80 years, regardless of gender.
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2 ≤ Hoehn-Yahr stage≤ 4.
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Maintain medication stability during the study period.
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Good compliance, written informed consent, and consent for long-term interventional treatment with iTBS.
Exclusion Criteria:
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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.
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Patients with significant cognitive impairment (MMSE < 24) or inability to complete questionnaires independently.
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Prior treatment with TMS, DBS or SCS.
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Severe physical illness and any physical illness that can precipitate epilepsy or intracranial hypertension, including cardiovascular and respiratory disease.
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Have human implantable materials such as intracranial stents, pacemakers, coronary stents, cochlear implants, etc.
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Are currently taking other investigational drugs.
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Any other condition that the investigator deems unsuitable for participation in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai | China | 200025 |
Sponsors and Collaborators
- Ruijin Hospital
Investigators
- Study Chair: Jun Liu, Professor, Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022043