NCT06171334Not yet recruiting
Remote Ischemic Conditioning in PPMS
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)
Source: ClinicalTrials.gov · Last updated 9 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 27 Nov 2023
- Start date
- 1 Jul 2024
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- University of Calgary
- Diseases
- Multiple sclerosis
- NCT number
- NCT06171334
What you commit to
- Study type: Interventional
- Planned participants: 45
- From 1 Jul 2024 to the primary completion date, 1 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.