Remote Ischemic Conditioning for Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04327687
• Other study ID #: k2019-54
• Status: Completed
• Phase: N/A
• Start date: August 18, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: February 2023
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
China	General Hospital of Northern Theater Command	ShenYang

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Unified Parkinson's disease Rating Scale - Session III	The Unified Parkinson´s Disease Rating Scale Part ? 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	Change in Unified Parkinson's disease Rating Scale - Session III	The Unified Parkinson´s Disease Rating Scale Part ? 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
Secondary	Changes on Depression	Assessment with Beck's depression inventory (BDI) .	12 weeks, 24weeks, 48 weeks
Secondary	Changes on Cognitive function	Rating with Montreal Cognitive Assessment (MOCA)	12 weeks, 24weeks, 48 weeks
Secondary	Changes on quality of life	It will be evaluated through the Parkinson Disease Questionnaire (PDQ-39).	12 weeks, 24weeks, 48 weeks
Secondary	Levodopa Equivalent Dose	Assessment with Research Team	12 weeks, 24weeks, 48 weeks
Secondary	frequency of adverse events	Adverse events to evaluate the safety and tolerability of Remote ischaemic conditioning	From screening up to 48 weeks