Parkinson's disease
Conditions
Interventions
Sponsors
Hospital of Chengdu University of TCM
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. PD patients Inclusion Criteria (1) Diagnosis of Parkinsons disease (PD) according to the Movement Disorder Society (MDS) Clinical Diagnostic Criteria (2015); (2) Aged between 40 and 70 years regardless of sex; (3) Right-handed (to ensure consistency in hemispheric activation); (4) Hoehn and Yahr stage 1–3 in the ON medication state; (5) Motor score (Part III) of the Movement Disorder Society-Unified Parkinsons Disease Rating Scale (MDS-UPDRS) =10 indicating clinically relevant motor dysfunction; (6) Disease duration >6 months with the ability and willingness to complete all study procedures (including repeated clinical assessments and MRI scanning); (7) Receiving stable dopaminergic medication for at least one month prior to enrollment; (8) Capable of understanding the study protocol and providing written informed consent either personally or via a legal guardian. Note: Participants must meet all criteria to be eligible. 2. Healthy controls To provide baseline neuroimaging (MRI) and serological (inflammatory markers transcriptome) data for comparison 30 healthy individuals will be recruited as controls. Their inclusion are as follows: (1) Aged between 40 and 70 years regardless of sex and right-handed. (2) No history of neurological psychiatric or hereditary diseases; in generally good health. (3) No acute illnesses (e.g. cold fever) during the study period. (4) Good compliance willing to adhere to study procedures and able to provide written informed consent. (5) No use of antibiotics anti-inflammatory drugs immunosuppressants or acid–base regulators within three months prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. PD patients Exclusion Criteria (1) Diagnosis of secondary parkinsonism (e.g. progressive supranuclear palsy multiple system atrophy); (2) Presence of serious cardiovascular cerebrovascular hepatic renal hematologic diseases malignancies or severe musculoskeletal conditions affecting gait (e.g. advanced osteoarthritis). (3) Coexisting central nervous system disorders or significant cognitive/psychiatric impairment: Mini-Mental State Examination (MMSE) score =18; major depression (HAMD-17 =24); diagnosed dementia; history of schizophrenia bipolar disorder or epilepsy. (4) Current use of medications affecting brain function including anticholinergics beta-blockers antipsychotics analgesics antihistamines or similar agents. (5) Use of antibiotics anti-inflammatory agents immunosuppressants acid–base regulators or traditional Chinese medicine within three months prior to enrollment. (6) Dermatological disorders limb defects at acupuncture sites or history of allergic reactions or severe needle phobia. (7) Abnormal brain findings on prior CT/MRI such as traumatic brain injury vascular malformation hydrocephalus brain tumor or history of brain surgery. (8) Contraindications to MRI (e.g. non-removable metal implants claustrophobia). (9) Pregnant or breastfeeding women. (10) History of alcohol or substance abuse. (11) Participation in other interventional clinical trials within the past three months. (12) Any other condition deemed unsuitable for study participation by the investigators. 2. Healthy controls Exclusion Criteria (1) Abnormal brain anatomy or definite lesions on MRI (e.g. tumors vascular malformations). (2) History or strong suspicion of alcohol or drug abuse. (3) History of chronic pain disorders. (4) Contraindications to MRI (e.g. metallic implants pacemakers claustrophobia). (5) Pregnant or breastfeeding women. (6) Participation in other clinical trials within the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III; | — |
Secondary
| Measure | Time frame |
|---|---|
| Movement Disorder Society Unified Parkinson's Disease Rating Scale;Freezing of Gait;Purdue Pegboard Test Score;Timed Up and Go Test;Levodopa Equivalent Daily Dose;39-Item Parkinsons Disease Questionnaire;Clinical Global Impression Scale;Serum inflammatory factors;Multimodal image data;Treatment Satisfaction; | — |
Countries
China
Contacts
Public ContactLiang Fanrong
Chengdu University of Traditional Chinese Medicine
Outcome results
None listed