Remote Ischemic Conditioning for Parkinson's Disease
- Conditions
- Parkinson's Disease
- Interventions
- Device: Remote ischaemic conditioningOther: conventional therapy
- Registration Number
- NCT04327687
- Lead Sponsor
- General Hospital of Shenyang Military Region
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description remote ischemic conditioning Remote ischaemic conditioning remote ischemic conditioning is a physical strategy performed by an electric auto-control device with cuffs placed on bilateral arms: five cycles of 5-min inflation and 5-min deflation one or two times per day. The duration of the treatment is six months. remote ischemic conditioning conventional therapy remote ischemic conditioning is a physical strategy performed by an electric auto-control device with cuffs placed on bilateral arms: five cycles of 5-min inflation and 5-min deflation one or two times per day. The duration of the treatment is six months. conventional therapy conventional therapy conventional therapy
- Primary Outcome Measures
Name Time Method Change in Unified Parkinson's disease Rating Scale - Session III 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 Outcome Measures
Name Time Method Changes on quality of life 12 weeks, 24weeks, 48 weeks It will be evaluated through the Parkinson Disease Questionnaire (PDQ-39).
Change in Unified Parkinson's disease Rating Scale - Session III 12 weeks, 48 weeks 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).
Changes on Depression 12 weeks, 24weeks, 48 weeks Assessment with Beck's depression inventory (BDI) .
Changes on Cognitive function 12 weeks, 24weeks, 48 weeks Rating with Montreal Cognitive Assessment (MOCA)
Levodopa Equivalent Dose 12 weeks, 24weeks, 48 weeks Assessment with Research Team
frequency of adverse events From screening up to 48 weeks Adverse events to evaluate the safety and tolerability of Remote ischaemic conditioning
Trial Locations
- Locations (1)
General Hospital of Northern Theater Command
🇨🇳ShenYang, China