Neuroprotective Effects of iTBS in PD

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Intermittent Theta Burst Stimulation; Parkinson Disease; Neuroprotection

Treatments: Device: sham iTBS; Device: intermittent theta burst stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05445505

2022043

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups

Early-start single iTBS group

Active Comparator group

Description:

The intensive period: 2 weeks The maintenance period: 12 weeks

Treatment:

Device: intermittent theta burst stimulation

Early-start double iTBS group

Active Comparator group

Description:

The intensive period: 2 weeks The maintenance period: 12 weeks

Treatment:

Device: intermittent theta burst stimulation

Delayed-start single iTBS group

Sham Comparator group

Description:

The intensive period: sham/iTBS, 2 weeks The maintenance period: daily sham/iTBS, 12 weeks

Treatment:

Device: intermittent theta burst stimulation

Device: sham iTBS

Delayed-start double iTBS group

Sham Comparator group

Description:

The intensive period: sham/iTBS, 2 weeks The maintenance period: twice daily sham/iTBS, 12 weeks

Treatment:

Device: intermittent theta burst stimulation

Device: sham iTBS