Individual Neuromodulation for PDS

Transcranial Direct Current Stimulation Clinical Trial

Official title:

Personalized Neuromodulation Treatment for Parkinson's Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06193278
• Other study ID #: PDS
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: Ruijin Hospital
• Contact: Jun Liu, Professor
• Phone: 64370045
• Email: jly0520[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuromodulation
• Parkinsonian Disorders
• Parkinsonian Syndromes
• Syndrome
• Transcranial Direct Current Stimulation
• Transcranial Magnetic Stimulation

Intervention

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.

Locations

Country	Name	City	State
China	Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Group differences of adverse event	Compare the changes in adverse event in the three intervention groups	6 weeks