Effects of Acute Intermittent Hypoxia on Neuroplasticity in MS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShirley Ryan AbilityLab

About this trial

This study seeks to explore changes in the neural pathways and arm function following a breathing intervention in the multiple sclerosis (MS) population. The breathing intervention, known as Acute Intermittent Hypoxia (AIH), involves breathing brief bouts of low levels of oxygen. Research has found AIH to be a safe and effective intervention resulting in increased ankle strength in people with MS. Here, the study examines arm and hand function before and after AIH. In order to better understand the brain and spinal cord response to AIH, the investigators will measure muscle response, and signals sent from the brain to the arm muscles before and after AIH.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of relapsing-remitting MS according to the McDonald criteria, over 5 years ago

Relapse free for at least 6 months

Expanded Disability Status Scale (EDSS) ≤7

Index finger abduction strength <5 according to Medical Research Council Scale, or 9-Hole Peg Test score >20 seconds in at least one hand

Disqualifiers

Another diagnosis (e.g., peripheral neuropathies or orthopedic) affecting upper limb function

Mini-Mental State Examination (MMSE) score <24

Modified Ashworth Scale score >3 on elbow joint

Uncontrolled hypertension or hypotension (outside 140/90 and 85/55 mmHg)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Acute Intermittent Hypoxia

    Other intervention

    During AIH, the participant will be equipped with a non-rebreathing face mask, and provided with the AIH intervention. The AIH intervention involves alternating breathing cycles. One cycle involves breathing air with lower oxygen concentration (9-10% oxygen) for 30 and 90 seconds, followed by breathing normal room air (21% oxygen) for a similar duration. This cycle is repeated 15 times in one session. Blood oxygen and heart rate are monitored throughout.

  • Sham Acute Intermittent Hypoxia

    Other intervention

    During Sham AIH, the participant will be equipped with a non-rebreathing face mask, and provided with the AIH intervention. The Sham AIH intervention involves alternating breathing cycles. One cycle involves breathing air closely resembling room air (\~21% oxygen) for 30 and 90 seconds, followed by breathing normal room air (21% oxygen) for a similar duration. This cycle is repeated 15 times in one session. Blood oxygen and heart rate are monitored throughout.

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: AIH firstExperimental treatment 2 interventions
Group B: Sham FirstExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Motor Evoked Potentials (MEPs) in First Dorsal Interosseous (FDI)

The MEPs will be elicited by Transcranial Magnetic Stimulation (TMS), a procedure that uses magnetic fields to stimulate nerve cells in the brain.

Time frame
Immediately before, immediately after, and 60 minutes after the intervention.
2

Changes in Spinal Reflex Threshold

Spinal reflect threshold will be measured by calculating the average change in threshold length recorded from the biceps tendon's indentation. A linear motor will be used to impose precise tendon indentations of the biceps brachii.

Time frame
Immediately before the intervention and immediately after the intervention.
3

Threshold For Detecting Passive Joint Movement

An assisted movement with enhanced sensation (AMES) will be used to rotate the participant's joint. The difference between the reference and matching joint angles is used to measure joint position sense. The investigators will present three target positions, and subjects will perform ipsilateral matching for each target 5 times.

Time frame
Immediately before the intervention and immediately after the intervention.
4

Accuracy of Direction Estimation of Passive Joint Movement

An AMES will be used to rotate the participant's joint. The difference between the reference and matching joint angles is used to measure joint position sense. The investigators will present three target positions, and subjects will perform ipsilateral matching for each target 5 times.

Time frame
Immediately before the intervention and immediately after the intervention.

Secondary outcomes

1

Grip Strength

The participant will squeeze a calibrated dynamometer to measure grip strength.

Time frame
Immediately before the intervention and immediately after the intervention.
2

Pinch Strength

The participant will pinch a calibrated pinch gauge to measure pinch strength.

Time frame
Immediately before the intervention and immediately after the intervention.
3

Index Finger Abduction Force

Index finger abduction force will be measured using a load cell. We will also record surface EMG activity from the FDI muscle.

Time frame
Immediately before the intervention and immediately after the intervention.
4

Nine-Hole Peg Test

A dexterity measurement involving placing 9 pegs in corresponding holes. Time to complete is measured.

Time frame
Immediately before the intervention and immediately after the intervention.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shirley Ryan AbilityLab

Lead sponsor

National Multiple Sclerosis Society

Collaborator