Individual Neuromodulation for PDS
Personalized Neuromodulation Treatment for Parkinson's Syndrome
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2023
CompletedFirst Submitted
Initial submission to the registry
December 21, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJanuary 10, 2024
August 1, 2023
1.7 years
December 21, 2023
January 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Group differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes
Compare the changes in UPDRS scores from baseline to post- treatment in the three intervention groups (UPDRS part3: range 0\~72, higher score is related to a worse outcome).
6 weeks
Secondary Outcomes (12)
Group differences of Progressive Supranuclear Palsy Rating Scale (PSPRS)
6 weeks
Group differences of Unified Multiple System Atrophy Rating Scale (UMSARS)
6 weeks
Group differences of Cortical Basal ganglia Functional Scale (CBFS)
6 weeks
Group differences of Berg Balance Scale (BBS) changes
6 weeks
Group differences of Hamilton depression scale-17 (HAMD-17) changes
6 weeks
- +7 more secondary outcomes
Study Arms (3)
muti-site stimulation group1
ACTIVE COMPARATORThe intervention period: 2 weeks muti-site: individual target (iTBS OR cTBS) / M1 (iTBS)
single-site stimulation group2
ACTIVE COMPARATORThe intervention period: 2 weeks muti-site: individual target (sham) / M1 (iTBS)
sham stimulation group3
SHAM COMPARATORThe intervention period: 2 weeks muti-site: individual target (sham) / M1 (sham)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2023
First Posted
January 5, 2024
Study Start
September 1, 2023
Primary Completion
May 31, 2025
Study Completion
June 30, 2025
Last Updated
January 10, 2024
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share