Individual Neuromodulation for PDS

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Parkinsonian Syndromes; Transcranial Direct Current Stimulation; Transcranial Magnetic Stimulation; Neuromodulation

Treatments: Device: Neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06193278

PDS

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

muti-site stimulation group1

Active Comparator group

Description:

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

Treatment:

Device: Neuromodulation

single-site stimulation group2

Active Comparator group

Description:

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

Treatment:

Device: Neuromodulation

sham stimulation group3

Sham Comparator group

Description:

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

Treatment:

Device: Neuromodulation