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NCT Number: NCT04327687

Remote Ischemic Conditioning for Parkinson's Disease

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).

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Northern Theater Command

Shenyang, 110840, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote ischaemic conditioning

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

Other

conventional therapy

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. Changes on Depression

    Time frame: 12 weeks, 24weeks, 48 weeks

    Assessment with Beck's depression inventory (BDI) .

  3. Changes on Cognitive function

    Time frame: 12 weeks, 24weeks, 48 weeks

    Rating with Montreal Cognitive Assessment (MOCA)

  4. Changes on quality of life

    Time frame: 12 weeks, 24weeks, 48 weeks

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

  5. Levodopa Equivalent Dose

    Time frame: 12 weeks, 24weeks, 48 weeks

    Assessment with Research Team

  6. frequency of adverse events

    Time frame: From screening up to 48 weeks

    Adverse events to evaluate the safety and tolerability of Remote ischaemic conditioning

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

Remote Ischemic Conditioning AS Adjuvant Therapy for Parkinson's Disease: A Prospective, Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 31, 2020
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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