Remote Ischemic Conditioning in PPMS

NCT06171334 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Calgary

Phase

Not applicable

Started

2024-07-01

Last updated

2024-05-09

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

Remote ischemic conditioning

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: Written informed consent obtained * Men and women aged of 18 and 65 years inclusive * With Primary Progressive Multiple Sclerosis, according to current diagnostic criteria * Screening Expanded Disability Status Scale score between 4.0 and 6.5 inclusive * Screening timed 25-foot walk (average of two trials) of 5.5 seconds or more Exclusion Criteria: Patients whose screening MRI scan shows gadolinium enhancing lesions * Patients with known renal insufficiency * Patients with known significant hepatic impairment * Patients with known allergy to gadolinium MRI contrast agent * Patients currently using immune-modulators such as ocrelizumab or hydroxychloroquine * Patients currently using therapeutic anticoagulation (blood thinners, such as warfarin, apixaban, rivaroxaban, dabigatran, enoxaparin) * Patients currently using Fampridine or 4-aminopyridine * Patients planning to start Fampridine or 4-aminopyridine during the study period * Patients planning to start Baclofen or Tizanidine during the duration of the study * Patients who increase the dose of Baclofen or Tizanidine during the study period * Patients who receive treatment with Botulinum toxin in the leg muscles during the study period * Patients who are unable or unwilling to undergo gadolinium enhanced MRI scans * Patients with known history of thrombotic events in the upper extremities

Primary outcome measure(s)

Timed 25-foot walk — 12 MONTHS
The primary endpoint in this study will be the worsening of disability, defined as an increase by 20% or more in the timed 25-foot walk (average of two trials) at 12 months follow-up compared to baseline.

Trial sites (1)

Facility	City	Region	Status
University of Calgary	Calgary	Canada

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06171334 on ClinicalTrials.gov ↗ ← All trials in Canada