Efficacy and Safety of a Combination of Emotional Freedom Technique with Acupuncture versus Acupuncture Alone to Treat Psychiatric Symptoms in Parkinson’s disease A protocol for a randomized, assessor-blind, parallel-group clinical trial
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0005964
- Lead Sponsor
- Daejeon Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
1) Aged 45 to 85
2) Diagnosed with Parkinson's disease
3) Hoehn and Yahr Scale 1-3
4) The 15-item Geriatric Depression Scale(GDS-15) over 6
5) Participants who voluntarily decided to participate and signed the consent form
6) Mini Mental State Examination-K(MMSE-K) over 24
1) Patients with dementia, Huntington's disease, or hydrocephalus
2) Patients with gait disturbance due to cerebral vascular accidents, brain tumor, or other cerebral diseases
3. Participants who have taken or changed the dosage of anti-Parkinsonism medications, materials, or medications that may affect depression(Ex. anti-anxiolytic drugs, anti-depressive drugs, anti-psychotic drugs, steroids, female hormones, L-dopa, Digitalis, bromide, cyclosporin, disulfiram, isoniazid, yohimbine), in recent 4 weeks
4) Not appropriate to participate in the trial due to the lab test results(Ex. over 2 times the upper reference limit of AST, ALT, T bilirubin, or creatinine)
5) Seriously unstable medical conditions (the investigator will decide based on Vital signs, EKG, and Chest PA by SOP. Ex. active TB on Chest PA, or signs of ventricular fibrillation or myocardial infarctions on EKG)
6) Participants who have been treated by Korean medical treatment related to Parkinson's disease in recent 2 weeks, that the treatment may affect this trial or the safety.
7) Pregnant or lactating women
8) Participants who are thought to be not appropriate to participate in this trial by the investigator.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Beck Depression Inventory (BDI)
- Secondary Outcome Measures
Name Time Method Amount of execise;Beck Depression Inventory (BDI);Parkinson’s disease Sleep Scale (PDSS);State-Trait Anxiety Inventory(STAI);K-FRAIL scale;UPDRS ?;Functional near-infrared spectroscopy (fNIRS)