Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Remote ischaemic conditioning
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.
Interventions
5 cycles of 5 minutes of upper limb ischaemia followed by 5 minutes of reperfusion. This will be delivered using a manual sphygmomanometer applied to the upper arm and activated to go through 5 such cycles automatically. The blood pressure cuff in the active treatment arm will inflate to 200 mmHg. RIC will be completed 1-2 times per day for six months.
OTHERconventional therapy
conventional therapy
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
a single-blind (outcomes assessor)
Intervention model description
Prospective randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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). |
| 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 |
| Changes on quality of life | 12 weeks, 24weeks, 48 weeks | It will be evaluated through the Parkinson Disease Questionnaire (PDQ-39). |
Countries
China
Outcome results
None listed