Clinical trial NCT06193278: Individual Neuromodulation for PDS
Official title: Personalized Neuromodulation Treatment for Parkinson's Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuromodulation
Parkinsonian Syndromes
Transcranial Magnetic Stimulation
Transcranial Direct Current Stimulation
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Group differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes
timeFrame: 6 weeks
Secondary outcomes:
measure: Group differences of Progressive Supranuclear Palsy Rating Scale (PSPRS)
timeFrame: 6 weeks
measure: Group differences of Unified Multiple System Atrophy Rating Scale (UMSARS)
timeFrame: 6 weeks
measure: Group differences of Cortical Basal ganglia Functional Scale (CBFS)
timeFrame: 6 weeks
measure: Group differences of Berg Balance Scale (BBS) changes
timeFrame: 6 weeks
measure: Group differences of Hamilton depression scale-17 (HAMD-17) changes
timeFrame: 6 weeks
measure: Group differences of Hamilton Anxiety Scale (HAMA) changes
timeFrame: 6 weeks
measure: Group differences of Mini-mental State Examination (MMSE) changes
timeFrame: 6 weeks
measure: Group differences of Montreal Cognitive Assessment (MoCA) changes
timeFrame: 6 weeks
measure: Group differences of 39-item Parkinson's Disease Questionnaire (PDQ-39) changes
timeFrame: 6 weeks
measure: Group differences of Wexner scores changes
timeFrame: 6 weeks
measure: Group differences of Standardized Swallowing Assessment (SSA) changes
timeFrame: 6 weeks
measure: Group differences of adverse event
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: