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)
What it found
No result yet.
What was tested
Treatment tested
- Remote ischemic conditioning
What it measured
Main measures
Timed 25-foot walk
12 MONTHS
Disability progressionWalking and mobility
Other measures (3)
Nine Hole Peg Test
12 MONTHS
Arm and hand functionMRI measure of remyelination
12 MONTHS
MRI lesionsMyelin repairSDMT (Single digit modalities test)
12 MONTHS
Thinking and memory
Who could take part
Progressive MS · 18 to 65
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
Papers
Background
Chen HS, Cui Y, Li XQ, Wang XH, Ma YT, Zhao Y, Han J, Deng CQ, Hong M, Bao Y, Zhao LH, Yan TG, Zou RL, Wang H, Li Z, Wan LS, Zhang L, Wang LQ, Guo LY, Li MN, Wang DQ, Zhang Q, Chang DW, Zhang HL, Sun J, Meng C, Zhang ZH, Shen LY, Ma L, Wang GC, Li RH, Zhang L, Bi C, Wang LY, Wang DL; RICAMIS Investigators. Effect of Remote Ischemic Conditioning vs Usual Care on Neurologic Function in Patients WithBackground
Camara-Lemarroy CR, Metz L, Smith EE, Dunn JF, Yong VW. Expanding the Potential Therapeutic Options for Remote Ischemic Preconditioning: Use in Multiple Sclerosis. Front Neurol. 2018 Jun 19;9:475. doi: 10.3389/fneur.2018.00475. eCollection 2018. No abstract available.
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History
Started
Jul 2024
Main results due
Mar 2026
Finished
Dec 2026