Remote Ischemic Conditioning for Parkinson's Disease

General Hospital of Shenyang Military Region50 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Parkinson's Disease

Interventions

Remote ischaemic conditioningDEVICE

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.

conventional therapyOTHER

conventional therapy

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

General Hospital of Northern Theater Command

Shenyang, China

Outcomes

Primary Outcomes

Change in Unified Parkinson's disease Rating Scale - Session III

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).

Time frame: 24weeks

Secondary Outcomes

Change in Unified Parkinson's disease Rating Scale - Session III

Time frame: 12 weeks, 48 weeks

Changes on Depression

Assessment with Beck's depression inventory (BDI) .

Time frame: 12 weeks, 24weeks, 48 weeks

Changes on Cognitive function

Rating with Montreal Cognitive Assessment (MOCA)

Time frame: 12 weeks, 24weeks, 48 weeks

Changes on quality of life

It will be evaluated through the Parkinson Disease Questionnaire (PDQ-39).

Time frame: 12 weeks, 24weeks, 48 weeks

Levodopa Equivalent Dose

Assessment with Research Team

Time frame: 12 weeks, 24weeks, 48 weeks

frequency of adverse events

Data from ClinicalTrials.gov

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