Individual Neuromodulation for PDS

Personalized Neuromodulation Treatment for Parkinson's Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Transcranial Magnetic Stimulation; Neuromodulation; Transcranial Direct Current Stimulation; Parkinsonian Syndromes
• Intervention / Treatment: Device: Neuromodulation

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Liu, Professor; Phone Number: +86-021 64370045; Email: jly0520@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Jun Liu, MD,PhD; Phone Number: +86-021 64370045; Email: jly0520@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: muti-site stimulation group1; The intervention period: 2 weeks muti-site: individual target (iTBS OR cTBS) / M1 (iTBS)	Device: 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.
Active Comparator: single-site stimulation group2; The intervention period: 2 weeks muti-site: individual target (sham) / M1 (iTBS)	Device: 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.
Sham Comparator: sham stimulation group3; The intervention period: 2 weeks muti-site: individual target (sham) / M1 (sham)	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Group differences of Progressive Supranuclear Palsy Rating Scale (PSPRS)	Compare the changes in PSPRS scores from baseline to post- treatment in the three intervention groups (psp patients specific).	6 weeks
Group differences of Unified Multiple System Atrophy Rating Scale (UMSARS)	Compare the changes in UMSARS scores from baseline to post- treatment in the three intervention groups (MSA patients specific).	6 weeks
Group differences of Cortical Basal ganglia Functional Scale (CBFS)	Compare the changes in CBFS scores from baseline to post- treatment in the three intervention groups (cbd patients specific).	6 weeks
Group differences of Berg Balance Scale (BBS) changes	Compare the changes in BBS scores from baseline to post-treatment in the three intervention groups (BBS: range 0~56, higher score is related to a better outcome).	6 weeks
Group differences of Hamilton depression scale-17 (HAMD-17) changes	Compare the changes in HAMD-17 scores from baseline to post-treatment in the three intervention groups (HAMD-17: range 0~38, higher score is related to a worse outcome).	6 weeks
Group differences of Hamilton Anxiety Scale (HAMA) changes	Compare the changes in HAMA scores from baseline to post-treatment in the three intervention groups (HAMA: range 0~64, higher score is related to a worse outcome).	6 weeks
Group differences of Mini-mental State Examination (MMSE) changes	Compare the changes in MMSE scores from baseline to post-treatment in the three intervention groups (MMSE: range 0~30, higher score is related to a better outcome).	6 weeks
Group differences of Montreal Cognitive Assessment (MoCA) changes	Compare the changes in MoCA scores from baseline to post-treatment in the three intervention groups (MoCA: range 0~30, higher score is related to a better outcome).	6 weeks
Group differences of 39-item Parkinson's Disease Questionnaire (PDQ-39) changes	Compare the changes in PDQ-39 scores from baseline to post-treatment in the three intervention groups (PDQ-39: range 0~156, higher score is related to a worse outcome).	6 weeks
Group differences of Wexner scores changes	Compare the changes in Wexner scores from baseline to post-treatment in the three intervention groups (Wexner: range 0~30, higher score is related to a worse outcome).	6 weeks
Group differences of Standardized Swallowing Assessment (SSA) changes	Compare the changes in SSA from baseline to post-treatment in the three intervention groups	6 weeks
Group differences of adverse event	Compare the changes in adverse event in the three intervention groups	6 weeks

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Basal Ganglia Diseases; Movement Disorders; Syndrome; Parkinsonian Disorders
• Other Study ID Numbers: PDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No