Neuroprotective Effects of iTBS in PD

Parkinson Disease Clinical Trial

Official title:

Neuroprotective Effects of Intermittent Theta Burst Stimulation in Parkinson's Disease: a Delayed-start Randomized Double-blind Sham Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05445505
• Other study ID #: 2022043
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2022
• Source: Ruijin Hospital
• Contact: Jun Liu, Professor
• Phone: 64370045
• Email: jly0520[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

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.

Related Conditions & MeSH terms

• Neuroprotection
• Parkinson Disease

Intervention

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.
• sham iTBS
The pseudo-stimulation device looks and sounds the same as the iTBS device

Locations

Country	Name	City	State
China	Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Group differences of Hoehn-Yahr stage	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).	28 weeks
Secondary	Group differences of Berg Balance Scale (BBS) changes	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).	28 weeks
Secondary	Group differences of Hamilton depression scale-17 (HAMD-17) changes	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).	28 weeks
Secondary	Group differences of Hamilton Anxiety Scale (HAMA) changes	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).	28 weeks
Secondary	Group differences of Mini-mental State Examination (MMSE) changes	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).	28 weeks
Secondary	Group differences of Montreal Cognitive Assessment (MoCA) changes	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).	28 weeks
Secondary	Group differences of 39-item Parkinson's Disease Questionnaire (PDQ-39) changes	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).	28 weeks
Secondary	Group differences of 16-item Sniffin' Sticks test (SS-16) changes	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).	28 weeks
Secondary	Group differences of Wexner changes	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).	28 weeks
Secondary	Group differences of adverse event	Compare the adverse event in four intervention groups.	28 weeks