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Behavioural Intervention

AIH First for Multiple Sclerosis

N/A

Waitlist Available

Led By Milap Sandhu, Pt, PhD

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Relapse free for at least 1 year

Motor Functional System Scale (FSS) between 2-4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and following each 5-day intervention block

Awards & highlights

Study Summary

This trial aims to study a new treatment for people with multiple sclerosis (MS) involving breathing low levels of oxygen for short periods. This treatment is called Acute Intermittent Hypoxia (

Who is the study for?

This trial is for people with multiple sclerosis (MS) who are interested in a novel intervention that involves breathing low levels of oxygen intermittently, similar to the air on a tall mountain. The study will explore how this affects brain activation and ankle strength.Check my eligibility

What is being tested?

The study is testing Acute Intermittent Hypoxia (AIH), where participants breathe short bursts of low-oxygen air. It compares AIH's effects on brain function and muscle strength against a sham procedure (a fake treatment that mimics AIH without using actual low oxygen).See study design

What are the potential side effects?

While not explicitly listed, side effects may include discomfort from breathing low levels of oxygen such as dizziness or lightheadedness, similar to what might be experienced at high altitudes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been free from cancer relapse for at least 1 year.

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My motor function is moderately impaired.

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My disability level is moderate to severe but I can still walk.

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I am between 18 and 75 years old.

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I have been diagnosed with a relapsing form of multiple sclerosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and following each 5-day intervention block

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and following each 5-day intervention block

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and following each 5-day intervention block for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ankle Plantarflexion Strength

Secondary outcome measures

Task fMRI

Other outcome measures

12-Item Multiple Sclerosis walk scale (MSWS-12)

Resting-State fMRI

Six-Minute Walk test

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sham FirstExperimental Treatment2 Interventions

Participants in the Sham First arm will undergo 5 days of Sham-Acute Intermittent Hypoxia Interventions. Following the 5 Days of Sham-AIH, after a 2-week washout period, this group will then undergo 5 days of AIH Interventions. The procedures are identical to Sham-AIH but with 9-10% oxygen for the first breath cycle

Group II: AIH FirstExperimental Treatment2 Interventions

Participants in the AIH First arm will undergo 5 days of Acute Intermittent Hypoxia Interventions. Following the 5 Days of AIH, after a 2-week washout period, this group will then undergo 5 days of Sham AIH Interventions. The procedures are identical to AIH but with 21% oxygen for both breath cycles

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityOTHER

1,585 Previous Clinical Trials

917,210 Total Patients Enrolled

6 Trials studying Multiple Sclerosis

394 Patients Enrolled for Multiple Sclerosis

Shirley Ryan AbilityLabLead Sponsor

192 Previous Clinical Trials

14,864 Total Patients Enrolled

4 Trials studying Multiple Sclerosis

322 Patients Enrolled for Multiple Sclerosis

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,964 Previous Clinical Trials

2,674,709 Total Patients Enrolled

18 Trials studying Multiple Sclerosis

1,787 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria to participate in this medical research study?

"Individuals eligible for participation in this research must have a diagnosis of multiple sclerosis and be between the ages of 18 and 75. The study aims to enroll a total of 21 participants."

Answered by AI

Are individuals older than 25 years eligible for participation in this research study?

"To be considered for this research study, applicants must fall within the age range of 18 to 75. It is noteworthy that there are a total of 68 trials designated for individuals under 18 years old and an additional 476 trials catering to those above the age of 65."

Answered by AI

Are there any ongoing efforts to enroll participants in this current medical study?

"The information provided on clinicaltrials.gov states that this particular trial is currently not accepting new participants. Initially posted on March 1st, 2024, the last update was made on February 22nd, 2024. While recruitment for this study is paused, there are a total of 679 other trials actively seeking candidates at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intermittent Hypoxia in Persons With Multiple Sclerosis

Milap Sandhu 2024. "Intermittent Hypoxia in Persons With Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06276634.

All > Primary Progressive Multiple Sclerosis