Individual Neuromodulation for PDS

NCT ID: NCT06193278

Last Updated: 2024-01-10

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

2023-09-01

Study Completion Date

2025-06-30

Brief Summary

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Parkinsonian Syndromes (PDS) with predominant motor dysfunction include progressive supranuclear palsy (PSP), multiple system atrophy (MSA) and corticobasal degeneration (CBD). Current treatment options for PDS are extremely limited due to the less understanding of disease pathophysiology and lack of therapeutic targets. Combining the results of previous studies and our group's previous research, sixty qualified PDS patients would be enrolled to conduct a prospective single-center randomized sham controlled clinical trial to verify the new therapeutic options that can improve symptoms and effectively slow the progression of the disease.

Detailed Description

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Conditions

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Neuromodulation Parkinsonian Syndromes Transcranial Magnetic Stimulation Transcranial Direct Current 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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muti-site stimulation group1

The intervention period: 2 weeks muti-site: individual target (iTBS OR cTBS) / M1 (iTBS)

Group Type ACTIVE_COMPARATOR

Neuromodulation

Intervention Type DEVICE

Noninvasive brain stimulation (NIBS) includes a variety of noninvasive neuromodulation techniques such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), and so on. Theta burst stimulation(TBS) is a new form of excitatory or inhibitory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session.

single-site stimulation group2

The intervention period: 2 weeks muti-site: individual target (sham) / M1 (iTBS)

Group Type ACTIVE_COMPARATOR

Neuromodulation

Intervention Type DEVICE

Noninvasive brain stimulation (NIBS) includes a variety of noninvasive neuromodulation techniques such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), and so on. Theta burst stimulation(TBS) is a new form of excitatory or inhibitory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session.

sham stimulation group3

The intervention period: 2 weeks muti-site: individual target (sham) / M1 (sham)

Group Type SHAM_COMPARATOR

Neuromodulation

Intervention Type DEVICE

Noninvasive brain stimulation (NIBS) includes a variety of noninvasive neuromodulation techniques such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), and so on. Theta burst stimulation(TBS) is a new form of excitatory or inhibitory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session.

Interventions

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Neuromodulation

Noninvasive brain stimulation (NIBS) includes a variety of noninvasive neuromodulation techniques such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), and so on. Theta burst stimulation(TBS) is a new form of excitatory or inhibitory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Compliance with the MDS revised clinical diagnostic criteria for Parkinsonian syndrome (2015 edition)
* aged \>40 years and \<80 years, regardless of gender.
* Patients were relatively stable during the study period and remained stable on medication
* Good compliance, written informed consent, and consent for NIBS long-term intervention treatment

Exclusion Criteria

* Patients with severe neuropsychiatric disorders or a previous history of severe neurologic conditions (e.g., epilepsy, cerebrovascular accident, etc.) or traumatic brain injury or brain surgery
* inability to complete the questionnaire independently
* Previous treatment with DBS or SCS; TMS or tDCS within 6 months
* Severe physical illness and any physical condition that can precipitate epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases
* Installation of intracranial stents, pacemakers, coronary stents, cochlear implants, and other human implantable materials
* is currently taking other investigational drugs or is participating in other clinical trials
* Any other condition that the investigator believes makes him or her unsuitable for participation in this study.
Minimum Eligible Age

40 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

Locations

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Department of Neurology and Institute 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, MD,PhD

Role: primary

64370045 ext. +86-021

Other Identifiers

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PDS

Identifier Type: -

Identifier Source: org_study_id

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