Remote Ischemic Conditioning for Multiple Sclerosis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Immune-modulators, Blood thinners

Disqualifiers: Renal insufficiency, Hepatic impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether remote ischemic conditioning (RIC) can help individuals with primary progressive multiple sclerosis (PPMS) maintain their walking ability. RIC involves temporarily restricting blood flow to a limb and has shown promise in protecting brain cells in stroke patients. Researchers aim to determine if RIC can repair nerve damage in those with PPMS. This trial suits individuals diagnosed with PPMS who find walking increasingly difficult. As an unphased trial, it offers participants a unique opportunity to contribute to pioneering research that could lead to new treatments for PPMS.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as immune-modulators, blood thinners, Fampridine, 4-aminopyridine, Baclofen, and Tizanidine. If you are on these medications, you may need to stop them to participate in the study.

What prior data suggests that this technique is safe for people with multiple sclerosis?

Research shows that Remote Ischemic Conditioning (RIC) is safe and generally well-tolerated. Studies with stroke patients indicate that RIC can protect the brain without causing harm. Additionally, research suggests that RIC can be used daily for extended periods without major issues. For other brain-related conditions, RIC has proven safe, with no significant negative effects reported. Overall, RIC appears to be a promising, gentle, non-drug therapy for improving health in various conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for multiple sclerosis (MS) involve medications that modify the immune system, such as interferons or monoclonal antibodies. However, remote ischemic conditioning (RIC) is unique because it doesn't rely on drugs. Instead, it uses a physical technique to temporarily restrict blood flow to an area, which might help protect the nervous system from damage. Researchers are excited about RIC for MS because it offers a non-invasive and potentially safer alternative that could complement existing therapies, providing new hope for patients with fewer side effects.

What evidence suggests that remote ischemic conditioning is effective for multiple sclerosis?

Research has shown that Remote Ischemic Conditioning (RIC), the treatment under study in this trial, could help treat neurological conditions. In stroke patients, RIC aided recovery and reduced brain damage, suggesting it might protect the brain. For people with multiple sclerosis (MS), studies indicate that RIC is safe and helps improve heart rate during walking. Animal studies support these findings, showing protective effects in nerve injury models. Although RIC hasn't been tested in MS for repairing nerve coverings, its safety and past success make it a promising option for further research in progressive MS. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with primary progressive multiple sclerosis (PPMS). Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and cannot have factors that would exclude them from safely participating in the study.

Inclusion Criteria

My condition is diagnosed as Primary Progressive Multiple Sclerosis.

It takes me more than 5.5 seconds to walk 25 feet.

Written informed consent obtained

Exclusion Criteria

I plan to start Baclofen or Tizanidine during the study.

Patients with known allergy to gadolinium MRI contrast agent

I have a known liver condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Remote Ischemic Conditioning (RIC) with 4 cycles daily to test its effect on preventing disability progression in PPMS

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments like the Timed 25-foot walk and MRI measures

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Remote Ischemic Conditioning

Trial Overview

The trial is testing Remote Ischemic Conditioning (RIC), a non-drug treatment involving repeated cycles of transient limb ischemia. The goal is to see if it can prevent worsening walking ability in PPMS patients by promoting remyelination in the nervous system.

How Is the Trial Designed?

Group I: RIC Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) has shown promise in reducing fatigue in individuals with multiple sclerosis, particularly in a randomized trial where significant fatigue reduction was observed in the active treatment group compared to sham (p=0.02).

The study involved two phases: the first with 15 participants receiving open-label tDCS showing modest fatigue reduction, and the second with 27 participants in a randomized trial demonstrating a more substantial effect, suggesting that tDCS could be a viable treatment option for managing MS-related fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remotely supervised transcranial direct current stimulation for the treatment of fatigue in multiple sclerosis: Results from a randomized, sham-controlled trial. Charvet, LE., Dobbs, B., Shaw, MT., et al.[2019]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06171334

NCT06171334 | Remote Ischemic Conditioning in PPMS

This important study was the first phase III trial to find a "protective" effect for RIC in neurological disease, and highlights the timeliness and potential ...

2.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2018.00475/epub

Remote Ischemic Preconditioning in MS

In support, the wide ranging neuroprotective effects of ReIP have been demonstrated in various rodent models of non-ischemic injury, such as optic nerve ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10114536/

Effect of Remote Ischemic Conditioning on Heart Rate ...

RIC was well tolerated and improved the heart rate response to walking in people with MS. Further studies on RIC in the management of MS are needed.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2405580825002717

Research progress on remote ischemic conditioning for ...

Clinical studies have confirmed that remote ischemic conditioning improves neurological recovery, reduces infarct volume, and enhances prognosis. However, the ...

5.

ahajournals.org

ahajournals.org/doi/10.1161/STROKEAHA.123.043279

Remote Ischemic Conditioning: Challenges and ...

One trial investigating RIC in 1776 patients with moderate ischemic stroke found an improvement in 90-day neurological outcomes if RIC was ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12234291/

Evaluating the safety and feasibility of remote ischemic ...

Remote Ischemic Conditioning (RIC) has shown potential in addressing these pathways by improving cerebral blood flow, reducing oxidative stress, ...

7.

systematicreviewsjournal.biomedcentral.com

systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-024-02725-8

Remote ischaemic conditioning for neurological disorders—a ...

RIC was found to be safe, with no significant neurological deterioration by day 7 in either group, as measured by NIHSS and GCS. Whilst this was ...