Clinical trial NCT05445505: Neuroprotective Effects of iTBS in PD
Official title: Neuroprotective Effects of Intermittent Theta Burst Stimulation in Parkinson's Disease: a Delayed-start Randomized Double-blind Sham Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuroprotection
Parkinson Disease
Intermittent Theta Burst Stimulation
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Group differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes
timeFrame: 28 weeks
Secondary outcomes:
measure: Group differences of Hoehn-Yahr stage
timeFrame: 28 weeks
measure: Group differences of Berg Balance Scale (BBS) changes
timeFrame: 28 weeks
measure: Group differences of Hamilton depression scale-17 (HAMD-17) changes
timeFrame: 28 weeks
measure: Group differences of Hamilton Anxiety Scale (HAMA) changes
timeFrame: 28 weeks
measure: Group differences of Mini-mental State Examination (MMSE) changes
timeFrame: 28 weeks
measure: Group differences of Montreal Cognitive Assessment (MoCA) changes
timeFrame: 28 weeks
measure: Group differences of 39-item Parkinson's Disease Questionnaire (PDQ-39) changes
timeFrame: 28 weeks
measure: Group differences of 16-item Sniffin' Sticks test (SS-16) changes
timeFrame: 28 weeks
measure: Group differences of Wexner changes
timeFrame: 28 weeks
measure: Group differences of adverse event
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
name: Jun Liu, Professor
role: STUDY_CHAIR
References: