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Remote Ischemic Conditioning for Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote ischaemic conditioning
conventional therapy
Sponsored by
General Hospital of Shenyang Military Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Remote ischaemic conditioning

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • General Hospital of Northern Theater Command

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

remote ischemic conditioning

conventional therapy

Arm Description

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.

conventional therapy

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
Changes on Depression
Assessment with Beck's depression inventory (BDI) .
Changes on Cognitive function
Rating with Montreal Cognitive Assessment (MOCA)
Changes on quality of life
It will be evaluated through the Parkinson Disease Questionnaire (PDQ-39).
Levodopa Equivalent Dose
Assessment with Research Team
frequency of adverse events
Adverse events to evaluate the safety and tolerability of Remote ischaemic conditioning

Full Information

First Posted
March 22, 2020
Last Updated
February 16, 2023
Sponsor
General Hospital of Shenyang Military Region
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1. Study Identification

Unique Protocol Identification Number
NCT04327687
Brief Title
Remote Ischemic Conditioning for Parkinson's Disease
Official Title
Remote Ischemic Conditioning AS Adjuvant Therapy for Parkinson's Disease: A Prospective, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 18, 2020 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Shenyang Military Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Remote ischaemic conditioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized clinical trial
Masking
Outcomes Assessor
Masking Description
a single-blind (outcomes assessor)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
remote ischemic conditioning
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional therapy
Arm Type
Active Comparator
Arm Description
conventional therapy
Intervention Type
Device
Intervention Name(s)
Remote ischaemic conditioning
Intervention Description
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
Other
Intervention Name(s)
conventional therapy
Intervention Description
conventional therapy
Primary Outcome Measure Information:
Title
Change in Unified Parkinson's disease Rating Scale - Session III
Description
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).
Time Frame
24weeks
Secondary Outcome Measure Information:
Title
Change in Unified Parkinson's disease Rating Scale - Session III
Description
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).
Time Frame
12 weeks, 48 weeks
Title
Changes on Depression
Description
Assessment with Beck's depression inventory (BDI) .
Time Frame
12 weeks, 24weeks, 48 weeks
Title
Changes on Cognitive function
Description
Rating with Montreal Cognitive Assessment (MOCA)
Time Frame
12 weeks, 24weeks, 48 weeks
Title
Changes on quality of life
Description
It will be evaluated through the Parkinson Disease Questionnaire (PDQ-39).
Time Frame
12 weeks, 24weeks, 48 weeks
Title
Levodopa Equivalent Dose
Description
Assessment with Research Team
Time Frame
12 weeks, 24weeks, 48 weeks
Title
frequency of adverse events
Description
Adverse events to evaluate the safety and tolerability of Remote ischaemic conditioning
Time Frame
From screening up to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Hui-Sheng
Organizational Affiliation
General Hospital of Shenyang Military Region
Official's Role
Study Chair
Facility Information:
Facility Name
General Hospital of Northern Theater Command
City
ShenYang
ZIP/Postal Code
110840
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Remote Ischemic Conditioning for Parkinson's Disease

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