Remote Ischemic Conditioning in PPMS
NCT06171334 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2024-05-09
Summary
Progressive MS remains the most difficult therapeutic challenge. Remyelination is a promising therapeutic strategy but an effective pharmacologic intervention remains elusive. Remote ischemic conditioning (RIC) is a non-pharmacologic intervention that has been studied in the context of stroke, where transient limb ischemia leads to neuroprotection. However, RIC has not yet been studied in MS. The investigators hypothesized that repeating RIC over several days may induce molecular/cellular changes in the CNS that promote remyelination. Since RIC is safe, tolerable and ready for clinical translation (recent stroke trials have shown promise), the investigators will run a clinical study to test RIC in people with primary progressive MS.
The purpose of this clinical trial is to determine if RIC in a dose of 4 cycles daily can prevent worsening of walking ability in people PPMS. The trial is funded through MS Canada as well as a private donation to the Hotchkiss Brain Institute MS Translational Clinical Trials Research Program and the University of Calgary. There is no sponsorship from the pharmaceutical industry.
Conditions
Interventions
- DEVICE
-
Remote ischemic conditioning
The intervention consists in Remote Ischemic conditioning (RIC), one session of 40-minutes duration per day for 12 months. The procedure will be performed by using an electric auto-control device by SnapDx Inc (Calgary, Canada) with a blood pressure cuff that inflates up to a pressure of 200 mmHg during the ischemic period. Participant will self-administer the RIC procedure at their home. The device records and documents each RIC cycle.
Sponsors & Collaborators
-
University of Calgary
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-01
- Primary Completion
- 2026-03-01
- Completion
- 2026-12-01
Countries
- Canada
Study Locations
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