Remote Ischemic Conditioning for Parkinson's Disease

NCT04327687 | Completed

• 1 other identifier: k2019-54
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Remote ischaemic conditioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Unified Parkinson's disease Rating Scale - Session III

  12 weeks, 48 weeks

• Changes on Depression

  12 weeks, 24weeks, 48 weeks

• Changes on Cognitive function

  12 weeks, 24weeks, 48 weeks

• Changes on quality of life

  12 weeks, 24weeks, 48 weeks

• Levodopa Equivalent Dose

  12 weeks, 24weeks, 48 weeks

Study Arms (2)

remote ischemic conditioning

EXPERIMENTAL

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.

Device: Remote ischaemic conditioning; Other: conventional therapy

conventional therapy

ACTIVE COMPARATOR

conventional therapy

Other: conventional therapy

Interventions

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.

remote ischemic conditioning

conventional therapy OTHER

conventional therapy

conventional therapy; remote ischemic conditioning

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, 110840, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Chen Hui-Sheng

  General Hospital of Shenyang Military Region

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: a single-blind (outcomes assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of neurology department

Model Details: Prospective randomized clinical trial

Study Record Dates

• First Submitted: March 22, 2020
• First Posted: March 31, 2020
• Study Start: August 18, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)