Tests a limb pressure treatment in people with primary progressive multiple sclerosis
Tests daily remote ischemic conditioning, a device-based limb pressure treatment, in adults with progressive MS.
Plain-language title generated from the registry record
Registry title: Remote Ischemic Conditioning in PPMS
Key facts
- Where
- Calgary, CanadaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06171334, who can take part
Where in Canada
- University Of CalgaryCalgary, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Calgary
- Trial code
- NCT06171334
- Record updated
- 9 May 2024
- Original description
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.Read full original descriptionShow less
Open-label, Single-center, Single-arm Futility Trial Evaluating Daily Remote Ischemic Conditioning for Reducing Progression of Disability in Patients With Primary Progressive Multiple Sclerosis (PPMS)
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.
Inclusion: 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: 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 who receive treatment with Botulinum toxin in the leg muscles during the study period; Patients with known renal insufficiency; Patients with known significant hepatic impairment; Patients with known allergy to gadolinium MRI contrast agent; Patients with known history of thrombotic events in the upper extremities; Patients whose screening MRI scan shows gadolinium enhancing lesions; 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 are unable or unwilling to undergo gadolinium enhanced MRI scans.