SetPoint System for Relapsing-Remitting Multiple Sclerosis

The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study

Recruiting N/A Interventional Study
Relapsing Remitting Multiple Sclerosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
22 – 60
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
SetPoint Medical Corporation · Industry
Who this trial is looking for

This trial is looking for adults with relapsing-remitting multiple sclerosis (RRMS) to test a new device. Participants will have a small device placed under their skin in a procedure to see if it helps with their condition.

Are You a Good Fit for This Trial?
Must be taking Disease-modifying therapy

You may be able to join if

  • I am between 22 and 60 years old.
  • I have been diagnosed with relapsing-remitting multiple sclerosis.
  • I have had MS for no more than 15 years.
  • I have certain vision test results that meet the trial's requirements.
  • I have not had a relapse in the past year.
  • I am currently on stable MS treatment.
  • I have a disability score of 2.5 to 6.5.

You may not be able to join if

  • I have other eye diseases that may affect my vision tests.
  • I have severe nearsightedness (myopia).
  • I have other serious neurological disorders.
  • I had optic neuritis in the last 6 months.
  • I received steroid treatment for MS symptoms in the last month.
  • My body mass index (BMI) is over 40.
  • I am allergic to MRI contrast agents or cannot have an MRI.
  • I am not a candidate for surgery.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial
The MS pilot study will assess the safety and investigate the remyelinating effects of the SetPoint System (study device) in adult patients diagnosed with relapsing-remitting multiple sclerosis (RRMS). The SetPoint System is intended for adjunctive use with standard of care therapy for RRMS. The study device contains a miniaturized stimulator (implant) that is surgically placed under general anest…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age 22-60 years at informed consent. * Diagnosis of RRMS by revised 2017 McDonald criteria. * MS disease duration does not exceed 15 years from date of diagnosis at the time of informed consent * Latency delay \>116 milliseconds on baseline full-field transient pattern reversa…
Contacts

Amy Derosier

aderosier@setpointmedical.com

CONTACT

Paula Timm

ptimm@setpointmedical.com

CONTACT