Remote Ischemic Conditioning for Parkinson's Disease

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

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).

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Other: conventional therapy; Device: Remote ischaemic conditioning

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • ShenYang, China, 110840
    • General Hospital of Northern Theater Command

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional therapy	Other: conventional therapy; conventional therapy
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.	Other: conventional therapy; conventional therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	24weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 weeks, 48 weeks
Changes on Depression	Assessment with Beck's depression inventory (BDI) .	12 weeks, 24weeks, 48 weeks
Changes on Cognitive function	Rating with Montreal Cognitive Assessment (MOCA)	12 weeks, 24weeks, 48 weeks
Changes on quality of life	It will be evaluated through the Parkinson Disease Questionnaire (PDQ-39).	12 weeks, 24weeks, 48 weeks
Levodopa Equivalent Dose	Assessment with Research Team	12 weeks, 24weeks, 48 weeks
frequency of adverse events	Adverse events to evaluate the safety and tolerability of Remote ischaemic conditioning	From screening up to 48 weeks

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region
• Investigators: Study Chair: Chen Hui-Sheng, General Hospital of Shenyang Military Region

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2020
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: March 22, 2020
• First Submitted That Met QC Criteria: March 29, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Parkinson's disease; Remote ischaemic conditioning
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: k2019-54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No