Neuroprotective Effects of iTBS in PD

NCT ID: NCT05445505

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neuroprotection Parkinson Disease Intermittent Theta Burst Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Early-start single iTBS group

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

Group Type ACTIVE_COMPARATOR

intermittent theta burst stimulation

Intervention Type DEVICE

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.

Early-start double iTBS group

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

Group Type ACTIVE_COMPARATOR

intermittent theta burst stimulation

Intervention Type DEVICE

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.

Delayed-start single iTBS group

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

Group Type SHAM_COMPARATOR

intermittent theta burst stimulation

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Delayed-start double iTBS group

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

Group Type SHAM_COMPARATOR

intermittent theta burst stimulation

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

sham iTBS

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

Intervention Type DEVICE

Other Intervention Names

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iTBS

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Liu, Professor

Role: STUDY_CHAIR

Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine

Locations

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Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Liu, Professor

Role: CONTACT

64370045 ext. +86-021

Facility Contacts

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Jun Liu, Professor

Role: primary

64370045 ext. +86-021

Other Identifiers

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2022043

Identifier Type: -

Identifier Source: org_study_id

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