Clinical trial NCT04327687: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Remote ischaemic conditioning
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Unified Parkinson's disease Rating Scale - Session III
timeFrame: 24weeks
Secondary outcomes:
measure: Change in Unified Parkinson's disease Rating Scale - Session III
timeFrame: 12 weeks, 48 weeks
measure: Changes on Depression
timeFrame: 12 weeks, 24weeks, 48 weeks
measure: Changes on Cognitive function
timeFrame: 12 weeks, 24weeks, 48 weeks
measure: Changes on quality of life
timeFrame: 12 weeks, 24weeks, 48 weeks
measure: Levodopa Equivalent Dose
timeFrame: 12 weeks, 24weeks, 48 weeks
measure: frequency of adverse events
timeFrame: From screening up to 48 weeks
Other outcomes:
Locations:
city: ShenYang
country: China
facility: General Hospital of Northern Theater Command
Study officials:
affiliation: General Hospital of Shenyang Military Region
name: Chen Hui-Sheng
role: STUDY_CHAIR
References: