Meridian Activation Remedy System for Parkinson's Disease
MARS-PD: Meridian Activation Remedy System for Parkinson's Disease - A Single-center, Rater-blinded, Parallel Randomized Controlled Trial
This study is testing a new treatment called the Meridian Activation Remedy System to see if it can help people with Parkinson's disease improve their symptoms and overall well-being compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Korea Health Industry Development Institute Government |
| Locations | 1 site (Daejeon) |
| Trial ID | NCT05621772 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and cost-effectiveness of the Meridian Activation Remedy System for Parkinson's Disease (MARS-PD) in patients with Parkinson's disease. It is a randomized controlled trial involving 88 participants, who will be assigned to either the experimental group receiving MARS-PD or a control group receiving usual care. The study will assess various outcomes, including motor and nonmotor symptoms, gait performance, and neuroplasticity over an 8-week treatment period followed by a 12-week follow-up. The primary outcome will be measured using the MDS-UPDRS Part III score.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 to 75 with a diagnosis of Parkinson's disease at Hoehn and Yahr stages I to III.
Not a fit: Patients who are clinically unstable, planning to undergo deep brain stimulation, or have significant cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for patients with Parkinson's disease by alleviating symptoms and enhancing overall function.
How similar studies have performed: While the specific approach of MARS-PD may be novel, similar interventions targeting motor and nonmotor symptoms in Parkinson's disease have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 45 to 75 years of age 2. Patients with PD, diagnosed according to the United Kingdom Parkinson's Diseases Society Brain Bank Criteria 3. Hoehn and Yahr scale stage I to III 4. Patients who have voluntarily decided to participate in the clinical study and signed the informed consent form Exclusion Criteria: 1. Clinically unstable patients (e.g., elevated aspartate transaminase (AST) or alanine aminotransferase (ALT) more than three-fold the upper limit of normal in the research institute's laboratory, heart failure, respiratory failure, etc.) 2. Patients who are planning to undergo deep brain stimulation within the study period 3. Pregnant or lactating women 4. Patients with MMSE-K (Mini-Mental State Exam) score of 18 or less 5. If there has been a change in the dosage of antiparkinsonian drugs (e.g., L-dopa, COMT (catechol-O-methyltransferase) inhibitor, Dopamine agonist, MAO-B (monoamine oxidase B) inhibitor, etc.) according to a doctor's prescription within the last 4 weeks prior to enrollment 6. Patients who are receiving manual therapy, exercise therapy, or rehabilitation therapy for Parkinson's disease according to a doctor's prescription within the last 4 weeks prior to enrollment, or are planning to receive such therapy within the study period 7. Patients who are not suitable for participation in this clinical study according to the judgment of the researcher
Where this trial is running
Daejeon
- Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University — Daejeon, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Ho Ryong Yoo, Prof. Dr. — Daejeon University
- Study coordinator: Miso S. Park, Prof. Dr.
- Email: miso.sophia.park@gmail.com
- Phone: +82-42-470-9541
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.