Neuroprotective Effects of iTBS in PD
Neuroprotective Effects of Intermittent Theta Burst Stimulation in Parkinson's Disease: a Delayed-start Randomized Double-blind Sham Controlled Study
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2022
CompletedFirst Posted
Study publicly available on registry
July 6, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMay 9, 2023
May 1, 2022
1.9 years
June 23, 2022
May 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Group differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes
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).
28 weeks
Secondary Outcomes (10)
Group differences of Hoehn-Yahr stage
28 weeks
Group differences of Berg Balance Scale (BBS) changes
28 weeks
Group differences of Hamilton depression scale-17 (HAMD-17) changes
28 weeks
Group differences of Hamilton Anxiety Scale (HAMA) changes
28 weeks
Group differences of Mini-mental State Examination (MMSE) changes
28 weeks
- +5 more secondary outcomes
Study Arms (4)
Early-start single iTBS group
ACTIVE COMPARATORThe intensive period: 2 weeks The maintenance period: 12 weeks
Early-start double iTBS group
ACTIVE COMPARATORThe intensive period: 2 weeks The maintenance period: 12 weeks
Delayed-start single iTBS group
SHAM COMPARATORThe intensive period: sham/iTBS, 2 weeks The maintenance period: daily sham/iTBS, 12 weeks
Delayed-start double iTBS group
SHAM COMPARATORThe intensive period: sham/iTBS, 2 weeks The maintenance period: twice daily sham/iTBS, 12 weeks
Interventions
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.
The pseudo-stimulation device looks and sounds the same as the iTBS device
Eligibility Criteria
You may qualify if:
- 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.
- ≤ 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jun Liu, Professor
Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2022
First Posted
July 6, 2022
Study Start
August 1, 2022
Primary Completion
June 30, 2024
Study Completion
December 31, 2024
Last Updated
May 9, 2023
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share
No individual participant data (IPD) was available to other researchers.