Remote Ischemic Conditioning for Parkinson’s Disease

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).

Full Title of Study: “Remote Ischemic Conditioning AS Adjuvant Therapy for Parkinson’s Disease: A Prospective, Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 30, 2022

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

  • Device: 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.
  • Other: conventional therapy
    • conventional therapy

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: conventional therapy
    • conventional therapy

Clinical Trial Outcome Measures

Primary Measures

  • Change in Unified Parkinson’s disease Rating Scale – Session III
    • Time Frame: 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 Measures

  • Change in Unified Parkinson’s disease Rating Scale – Session III
    • Time Frame: 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
    • Time Frame: 12 weeks, 24weeks, 48 weeks
    • Assessment with Beck’s depression inventory (BDI) .
  • Changes on Cognitive function
    • Time Frame: 12 weeks, 24weeks, 48 weeks
    • Rating with Montreal Cognitive Assessment (MOCA)
  • Changes on quality of life
    • Time Frame: 12 weeks, 24weeks, 48 weeks
    • It will be evaluated through the Parkinson Disease Questionnaire (PDQ-39).
  • Levodopa Equivalent Dose
    • Time Frame: 12 weeks, 24weeks, 48 weeks
    • Assessment with Research Team
  • frequency of adverse events
    • Time Frame: From screening up to 48 weeks
    • Adverse events to evaluate the safety and tolerability of Remote ischaemic conditioning

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • General Hospital of Shenyang Military Region
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hui-Sheng Chen, Director of neurology department – General Hospital of Shenyang Military Region
  • Overall Official(s)
    • Chen Hui-Sheng, Study Chair, General Hospital of Shenyang Military Region

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