Parkinson's disease
Conditions
Interventions
Repetitive Transcranial Magnetic Stimulation (rTMS) plus Scalp Acupuncture Group:Stimulation will target the posterior putamen-cortical network mapping point using rTMS, followed by scalp acupuncture
Sham rTMS plus Acupuncture Group:Sham rTMS will be administered first, followed by scalp acupuncture within 30 minutes after each sham rTMS session. The treatment will be conducted once daily, five da
rTMS plus Sham Acupuncture Group:The target will receive active repetitive transcranial magnetic stimulation (rTMS), followed by sham scalp acupuncture administered within 30 minutes after each rTMS s
Sham rTMS plus Sham Acupuncture Group:Sham rTMS will be administered first, followed by sham scalp acupuncture within 30 minutes after each sham rTMS session. This procedure will be conducted once dai
Healthy control group:None
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: This study consists of three parts. The inclusion criteria for each part are as follows: 1. Inclusion Criteria for Study Part 1: (1) Inclusion Criteria for PD Patients: 1) Meets the International Parkinson and Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease (2015) and presents with postural and gait disturbance, defined as a score >=1 on Item 2.12 (Walking and Balance) and/or Item 2.13 (Freezing of Gait) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. 2) Aged between 45 and 80 years (inclusive), any gender, right-handed. 3) Has been on stable anti-parkinsonian medication for at least 3 months. 4) Hoehn and Yahr (H-Y) stage 1 to 4, with disease duration =1 on Item 2.12 (Walking and Balance) and/or Item 2.13 (Freezing of Gait) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. 2) Aged between 45 and 80 years (inclusive), any gender, right-handed. 3) Has been on stable anti-parkinsonian medication for at least 3 months, with no adjustments to the medication regimen planned before, during, or immediately after the TMS treatment course. 4) Hoehn and Yahr (H-Y) stage 1 to 4, with disease duration <= 3 years. 5) Able to understand the study, agrees to participate, and provides written informed consent.
Exclusion criteria
Exclusion criteria: This study consists of three parts. The exclusion criteria for each part are as follows: 1. Exclusion Criteria for Study Part 1: (1) For PD Patients: 1) Parkinsonism due to other causes, or other neurological and movement disorders such as epilepsy, stroke, or dementia. 2) History of head trauma or brain surgery (e.g., ablative surgery, deep brain stimulation). 3) Comorbid severe psychiatric disorders, or severe diseases of the cardiovascular, hepatic, renal, respiratory, gastrointestinal, hematologic, nervous, or endocrine systems, or infectious diseases. 4) Pregnant or lactating women. 5) History of drug or alcohol abuse; use of other medications affecting the extrapyramidal system. 6) Participation in another clinical trial within one month prior to enrollment or current participation in another clinical study. 7) Severe and uncontrollable limb or head tremor. 8) Inability to cooperate with clinical assessments due to severe hearing or visual impairment, severe language barriers, severe limb injuries, etc. 9) Contraindications for MRI (e.g., pacemaker, cardiac stent, artificial heart valve, fixation plates after fracture surgery). (2) For Healthy Controls: 1) History or presence of severe cardiovascular, hepatic, renal, respiratory, gastrointestinal, hematologic, nervous, or endocrine system diseases, or any other major condition deemed by the investigator as unsuitable for participation. 2) Severe psychiatric disorders or infectious diseases. 3) History of head trauma or brain surgery. 4) Pregnant or lactating women. 5) History of drug or alcohol abuse; use of medications affecting the extrapyramidal system. 6) Participation in another clinical trial within one month prior to enrollment or current participation in another clinical study. 7) Inability to communicate effectively due to severe hearing or visual impairment, severe language barriers, etc. 8) Contraindications for MRI (e.g., pacemaker, cardiac stent, artificial heart valve, fixation plates after fracture surgery). 2. Exclusion Criteria for Study Parts 2 and 3: 1) Parkinsonism due to other causes, or other neurological and movement disorders such as epilepsy, stroke, or dementia. 2) History of head trauma or brain surgery (e.g., ablative surgery, deep brain stimulation). 3) Comorbid severe psychiatric disorders, or severe diseases of the cardiovascular, hepatic, renal, respiratory, gastrointestinal, hematologic, nervous, or endocrine systems, or infectious diseases. 4) Pregnant or lactating women. 5) History of drug or alcohol abuse; use of other medications affecting the extrapyramidal system. 6) Participation in another clinical trial within one month prior to enrollment or current participation in another clinical study. 7) Severe and uncontrollable limb or head tremor. 8) Inability to cooperate with clinical assessments due to severe hearing or visual impairment, severe language barriers, severe limb injuries, etc. 9) Contraindications for TMS and MRI (e.g., pacemaker, cardiac stent, artificial heart valve, cochlear implant, etc.) or EEG (e.g., history of craniocerebral trauma or skull defect, scalp infection, open wounds, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MDS-UPDRS-?; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Hoehn and Yahr Staging Scale;Timed Up and Go Test;Freezing of Gait Questionnaire;Berg Balance Scale;Modified Ashworth Scale;Gait Analysis Parameters;Non-Motor Symptoms Scale;Parkinson‘s Disease Sleep Scale;39-Item Parkinson‘s Disease Questionnaire;Montreal Cognitive Assessment Basic;Hamilton Depression Rating Scale;Hamilton Anxiety Rating Scale;MRI Analysis Metrics;EEG Analysis Metrics; | — |
Countries
China
Contacts
Public ContactJuanjuan Lu
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed