Neuromodulation, Parkinsonian Syndromes, Transcranial Direct Current Stimulation, Transcranial Magnetic Stimulation
Conditions
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.
Interventions
DEVICENeuromodulation
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.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 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 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 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 adverse event | 6 weeks | Compare the changes in adverse event in the three intervention groups |
| 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). |
Countries
China
Contacts
Primary ContactJun Liu, Professor
Outcome results
None listed