Remote Ischemic Conditioning for Parkinson's Disease

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status: Completed

Conditions: Parkinson's Disease

Treatments: Device: Remote ischaemic conditioning; Other: conventional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04327687

k2019-54

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

remote ischemic conditioning

Experimental group

Description:

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.

Treatment:

Other: conventional therapy

Device: Remote ischaemic conditioning

conventional therapy

Active Comparator group

Description:

conventional therapy

Treatment:

Other: conventional therapy