Remote Ischemic Conditioning AS Adjuvant Therapy for Parkinson's Disease: A Prospective, Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- General Hospital of Shenyang Military Region
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in Unified Parkinson's disease Rating Scale - Session III
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose is to evaluate feasibility and efficacy of Remote Ischemic Conditioning(RIC) as adjuvant therapy for Parkinson's Disease(PD). Sixty patients will be randomized into 2groups: RIC group receiving Remote Ischemic Conditioning except conventional therapy（n=30）and control group with conventional therapy (n=30).
Detailed Description
Remote ischaemic conditioning (RIC) is a procedure whereby ischaemia is induced to a limb for short periods of time by inflating pressure cuffs around arms to above systolic pressures (mmHg). This procedure induce neurohormonal, systemic or vascular changes in the body. Such changes often result in improved collateralisation of blood supply to various areas of the body, as well as improved efficiencies of cellular metabolism. RIC has been shown to improve outcomes in patients with heart attacks, strokes, but is not investigated for PD. We argue that RIC may exert neuroprotective effect on PD due to its multiple mechanisms. The aim of the study is to evaluate the impact of RIC on long term outcomes in patients with PD.
Investigators
Hui-Sheng Chen
Director of neurology department
General Hospital of Shenyang Military Region
Eligibility Criteria
Inclusion Criteria
- •Age between 40 - 70 years;
- •diagnosed with idiopathic PD;
- •a rating of 1-3 on the Hoehn and Yahr Scale;
- •On optimized dopaminergic therapy for 4 weeks prior to enrollment;
- •Be able to complete the research scale evaluation;
- •sign informed consent.
Exclusion Criteria
- •Atypical Parkinsonism or other significant brain conditions such as a stroke;
- •Significant mental disease or psychosis;
- •History or presence of significant peripheral vascular disease in the upper limbs;
- •Presence of skin ulceration to the arms;
- •Deep Brain Stimulation ( DBS);
- •Taking part in another clinical trial of an investigational medicinal product;
- •Life expectancy less than 1 year due to Severe medical disease;
- •other reasons that are unsuitable for the trial in the investigator's opinion.
Outcomes
Primary Outcomes
Change in Unified Parkinson's disease Rating Scale - Session III
Time Frame: 24weeks
The Unified Parkinson´s Disease Rating Scale Part Ⅲ is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 (Best score possible) to 108 (Worst score possible).
Secondary Outcomes
- Changes on quality of life(12 weeks, 24weeks, 48 weeks)
- Change in Unified Parkinson's disease Rating Scale - Session III(12 weeks, 48 weeks)
- Changes on Depression(12 weeks, 24weeks, 48 weeks)
- Changes on Cognitive function(12 weeks, 24weeks, 48 weeks)
- Levodopa Equivalent Dose(12 weeks, 24weeks, 48 weeks)
- frequency of adverse events(From screening up to 48 weeks)