Individual Neuromodulation for PDS
- Conditions
- Parkinsonian SyndromesTranscranial Magnetic StimulationTranscranial Direct Current StimulationNeuromodulation
- Interventions
- Device: Neuromodulation
- Registration Number
- NCT06193278
- Lead Sponsor
- Ruijin Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description muti-site stimulation group1 Neuromodulation The intervention period: 2 weeks muti-site: individual target (iTBS OR cTBS) / M1 (iTBS) single-site stimulation group2 Neuromodulation The intervention period: 2 weeks muti-site: individual target (sham) / M1 (iTBS) sham stimulation group3 Neuromodulation The intervention period: 2 weeks muti-site: individual target (sham) / M1 (sham)
- Primary Outcome Measures
Name Time Method Group differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes 6 weeks 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).
- Secondary Outcome Measures
Name Time Method Group differences of Progressive Supranuclear Palsy Rating Scale (PSPRS) 6 weeks Compare the changes in PSPRS scores from baseline to post- treatment in the three intervention groups (psp patients specific).
Group differences of Berg Balance Scale (BBS) changes 6 weeks 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).
Group differences of Unified Multiple System Atrophy Rating Scale (UMSARS) 6 weeks Compare the changes in UMSARS scores from baseline to post- treatment in the three intervention groups (MSA patients specific).
Group differences of Hamilton depression scale-17 (HAMD-17) changes 6 weeks 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).
Group differences of Cortical Basal ganglia Functional Scale (CBFS) 6 weeks Compare the changes in CBFS scores from baseline to post- treatment in the three intervention groups (cbd patients specific).
Group differences of Hamilton Anxiety Scale (HAMA) changes 6 weeks 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).
Group differences of Mini-mental State Examination (MMSE) changes 6 weeks 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).
Group differences of Montreal Cognitive Assessment (MoCA) changes 6 weeks 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).
Group differences of 39-item Parkinson's Disease Questionnaire (PDQ-39) changes 6 weeks 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).
Group differences of Standardized Swallowing Assessment (SSA) changes 6 weeks Compare the changes in SSA from baseline to post-treatment in the three intervention groups
Group differences of Wexner scores changes 6 weeks 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).
Group differences of adverse event 6 weeks Compare the changes in adverse event in the three intervention groups
Trial Locations
- Locations (1)
Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China