Remote Ischemic Conditioning for Parkinson's Disease

NCT ID: NCT04327687

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-18
• Study Completion Date: 2022-11-30

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

remote ischemic 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.

Group Type: EXPERIMENTAL

Remote ischaemic conditioning

Intervention Type: DEVICE

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 therapy

Intervention Type: OTHER

conventional therapy

conventional therapy

conventional therapy

Group Type: ACTIVE_COMPARATOR

conventional therapy

Intervention Type: OTHER

conventional therapy

Interventions

Remote ischaemic conditioning

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.

Intervention Type: DEVICE

conventional therapy

conventional therapy

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Director of neurology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chen Hui-Sheng

Role: STUDY_CHAIR

General Hospital of Shenyang Military Region

Locations

General Hospital of Northern Theater Command

Shenyang, , China

Countries

China

Other Identifiers

k2019-54

Identifier Type: -

Identifier Source: org_study_id