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

45 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Remote Ischemic Conditioning for Multiple Sclerosis?

Remote ischemic conditioning (RIC) has been shown to improve cardiovascular responses to exercise in healthy individuals, suggesting potential benefits for people with multiple sclerosis, although its specific effects in MS patients are not yet known. ^{1 2 3 4 5}

How is Remote Ischemic Conditioning different from other treatments for multiple sclerosis?

Remote Ischemic Conditioning (RIC) is unique because it involves exposing parts of the body to short periods of restricted blood flow followed by reperfusion (restoration of blood flow), which is different from typical MS treatments that often focus on medication or physical therapy. This approach aims to improve cardiovascular responses, which is not a common target in standard MS therapies. ^{1 2 4 5 6}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: RIC Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Findings from Research

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Telerehabilitation for persons with multiple sclerosis. A Cochrane review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Telerehabilitation benefits patients with multiple sclerosis in an urban setting. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Home-based physical telerehabilitation in patients with multiple sclerosis: a pilot study. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Effect of Remote Ischemic Conditioning on Heart Rate Responses to Walking in People with Multiple Sclerosis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Delivering Transcranial Direct Current Stimulation Away From Clinic: Remotely Supervised tDCS. [2020]

6. England 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. [2019]