Parkinson's DiseaseNCT04327687
Remote Ischemic Conditioning for Parkinson's Disease
A study testing Remote ischaemic conditioning and conventional therapy in people with Parkinson's Disease, run by General Hospital of Shenyang Military Region at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Remote ischaemic conditioning and conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2020to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Remote ischaemic conditioning, conventional therapy
- Keywords
- Parkinson's disease, Remote ischaemic conditioning
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischaemic conditioningDevice
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.
conventional therapyOther
conventional therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Remote ischaemic conditioning; Other: conventional therapy |
| conventional therapy | Active comparator | conventional therapy Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24weeks
Secondary outcomes (6)
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).
Measured: 12 weeks, 48 weeks
Changes on Depression
Assessment with Beck's depression inventory (BDI) .
Measured: 12 weeks, 24weeks, 48 weeks
Changes on Cognitive function
Rating with Montreal Cognitive Assessment (MOCA)
Measured: 12 weeks, 24weeks, 48 weeks
Changes on quality of life
It will be evaluated through the Parkinson Disease Questionnaire (PDQ-39).
Measured: 12 weeks, 24weeks, 48 weeks
Levodopa Equivalent Dose
Assessment with Research Team
Measured: 12 weeks, 24weeks, 48 weeks
frequency of adverse events
Adverse events to evaluate the safety and tolerability of Remote ischaemic conditioning
Measured: From screening up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start18 Aug 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
- Investigators
- Chen Hui-Sheng, Study chair, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327687
- Sponsor's protocol ID
- k2019-54
- Status last verified
- Feb 2023
- First submitted
- 22 Mar 2020
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning AS Adjuvant Therapy for Parkinson's Disease: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04327687
- Acronym / sponsor ID
- k2019-54
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Remote ischaemic conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| remote ischemic conditioning | Experimental | Device: Remote ischaemic conditioning, Other: conventional therapyremote 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 | Active comparator | Other: conventional therapyconventional therapy |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischaemic conditioning5 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. | Device | remote ischemic conditioning |
| conventional therapyconventional therapy | Other | conventional therapy, remote ischemic conditioning |
Primary outcome
Change in Unified Parkinson's disease Rating Scale - Session III
Time frame: 24weeks
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).
6 secondary outcomes
Change in Unified Parkinson's disease Rating Scale - Session III
Time frame: 12 weeks, 48 weeks
Changes on Depression
Time frame: 12 weeks, 24weeks, 48 weeks
Changes on Cognitive function
Time frame: 12 weeks, 24weeks, 48 weeks
Changes on quality of life
Time frame: 12 weeks, 24weeks, 48 weeks
Levodopa Equivalent Dose
Time frame: 12 weeks, 24weeks, 48 weeks
frequency of adverse events
Time frame: From screening up to 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Hui-Sheng study chair
General Hospital of Shenyang Military Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischaemic conditioning and conventional therapy in people with Parkinson's Disease, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Unified Parkinson's disease Rating Scale - Session III (time frame: 24weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.