Multiple Sclerosis
Conditions
Keywords
Acute Intermittent Hypoxia
Brief summary
This study will look at the safety, tolerability and feasibility of a non-invasive treatment called Acute Intermittent Hypoxia (AIH) in people with Multiple Sclerosis (MS) at different stages of the disease course.
Detailed description
AIH is a treatment where people breathe reduced amounts of oxygen (10% oxygen) for a short period of time alternating with normal oxygen levels (21%) through a facemask that is attached to an oxygen tank with 10% 02. Participants will undergo 6 AIH treatment sessions over 3-4 weeks. AIH will be administered to 3 unique groups of people: 1) People with advanced MS disability who are no longer ambulatory, 2) People who experienced a disabling relapse within the past 4 weeks and 3) People with non-active, progressive MS who retain some ambulatory ability. There will be one baseline and two post-treatment assessments (1 and 5 weeks following the last AIH session).
Interventions
Hypoxia (10% O2) will be administered via a non-rebreather face mask connected to an oxygen tank supplying the 10% O2. Each session will involve 15 cycles of hypoxia, each lasting 90 seconds, interspersed with 60 second cycles of normoxia. The total duration of each session will be approximately 37 minutes. An inline oxygen analyzer will allow recording of the percentage of oxygen being delivered. A fingertip pulse-oximeter will be worn throughout to ensure that oxygen saturation (SpO2) falls to a nadir between 80 - 87% during hypoxic episodes and heart rate monitoring will be performed. Blood pressure will be checked prior to and following each session (within 5 minutes of treatment cessation).
Sponsors
University of Saskatchewan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot interventional study where the investigational drug product is 10% oxygen delivered intermittently. (No Objection Letter File # from Health Canada HC6-024-c292683)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Group 1: * People with a confirmed diagnosis of MS and advanced disability level (Expanded Disability Status Scale (EDSS) \>6.5 and \<9) * Without relapse for at least 90 days prior * Older than age 18 Group 2: * People with a confirmed diagnosis of relapsing remitting MS * Acute disabling relapse onset within the past 4 weeks. A disabling relapse will be defined as at least 1.0-point increase on the EDSS. * Older than age 18 Group 3: * People with a confirmed diagnosis of MS that is non-active and progressive (Primary or Secondary Progressive MS). Non-active will be defined as without MS relapse, new/enlarging or enhancing MRI lesions within the past 1 year. * EDSS \<=6.5 * Older than age 18
Exclusion criteria
* Pregnancy * Any of the following documented respiratory disorders: obstructive sleep apnea, chronic obstructive pulmonary disease, uncontrolled asthma, hypoxic pulmonary disease, respiratory infection in the previous 3 months * Ischemic cardiac disease * Cardiac arrhythmia * Severe hypertension (\>160/100) * Seizure disorders * Medically unstable in another capacity * Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 < 78%, Heart rate < 50 beats per minute (bpm) or > 160 bpm | During the six AIH treatment session in weeks 1-4 | Number of episodes of each outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Worsening on a verbal response 9-Item subjective symptom checklist | During the six AIH treatment sessions in weeks 1-4 | Symptom checklist to be administered during AIH treatments. Includes the following: Chest pain, shortness of breath, lightheadedness, neck pain, dizziness, arm pain (left side for cardiac symptoms), sweatiness/feeling warm, sensory changes and increased weakness. |
| Functional testing 1: Nine-Hole Peg test | Baseline, 1- and 5- weeks after the final AIH treatment session | A test of hand function and dexterity |
| Functional testing 2: Symbol Digit Modalities Test | Baseline, 1- and 5- weeks after the final AIH treatment session | A cognitive test of processing speed |
| Functional testing 3: Timed 25-Foot walk test | Baseline, 1- and 5- weeks after the final AIH treatment session | A test of gait |
| Patient Reported Symptom Outcomes 1: Multiple Sclerosis Impact Scale (MSIS-29) | Baseline, 1- and 5- weeks after the final AIH treatment session | An assessment of how MS impacts a person's function |
| Patient Reported Symptom Outcomes 2: Modified Fatigue Impact Scale | Baseline, 1- and 5- weeks after the final AIH treatment session | An assessment of how fatigue impacts a person's function |
| Transcranial Magnetic Stimulation (TMS) | Baseline, 1- and 5- weeks after the final AIH treatment session | TMS uses a magnetic coil placed over the scalp to stimulate cortical neurons on the surface of the brain to elicit a motor evoked potential (MEP). The amount of stimulator output required to obtain a MEP is an indicator of the level of excitability of the neurons; lower threshold indicating greater excitability AIH may decrease inhibition and increase excitation; mechanisms necessary when recovering from neurological injuries. |
Contacts
CONTACTKatherine B Knox, MD, FRPC
CONTACTSarah Donkers, PhD
Outcome results
None listed