What side effects are associated with this type of intervention?

Common treatments for spinal cord injury that aim to stimulate neuroplasticity and enhance motor learning, such as repetitive acute intermittent hypoxia (AIH), transcutaneous electrical nerve stimulation (TENS), percutaneous electrical nerve stimulation (PENS), and spinal cord stimulation (SCS), have various side effects. AIH is generally well-tolerated but may cause mild discomfort or transient hypoxia-related symptoms. TENS and PENS can lead to skin irritation, discomfort at the electrode site, and, rarely, muscle twitching or pain. SCS may cause surgical complications, infection, lead migration, and hardware malfunction. Overall, these treatments are considered relatively safe, but patients should be monitored for any adverse effects.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments that directly align with the concept of Repetitive Acute Intermittent Hypoxia (RAIH) for spinal cord injury. Current FDA-approved treatments for SCI primarily focus on managing symptoms and preventing further damage. These include medications like corticosteroids to reduce inflammation and surgical interventions to stabilize the spine. Research is ongoing in the field of neuroplasticity and motor learning, but no treatments similar to RAIH have received FDA approval yet.

What other types of research exist?

Promising novel alternatives to Repetitive Acute Intermittent Hypoxia for spinal cord injury patients include: 1) Mesenchymal stem cell therapy, which has shown potential in secreting neurotrophic factors and promoting neuroplasticity. 2) Antisense oligonucleotide therapy, particularly for genetic forms of neurodegenerative diseases, which can modulate gene expression and improve motor function. 3) High-dose methylcobalamin, which has demonstrated neuroprotective effects and potential in enhancing motor neuron function. 4) VEGF (Vascular Endothelial Growth Factor) delivery, which has been shown to protect motoneurons and promote motor recovery in animal models. These therapies represent cutting-edge approaches that could offer significant benefits for SCI patients.

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The Effect of Acute Intermittent Hypoxia on Motor Learning

N/A

Waitlist Available

Research Sponsored by University of Colorado, Boulder

Eligibility Criteria Checklist

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

Must have

18 to 70 years old (the latter to reduce likelihood of heart disease)

AIS A-D at initial screen, or other non-traumatic spinal cord injury disorders (e.g. multiple sclerosis, ALS, tumors, acute transverse myelitis, etc.)

Must not have

Depression or manic disorders

Untreated painful musculoskeletal dysfunction, fracture or pressure sore

Timeline

Screening 3 weeks

Treatment Varies

Follow Up we will measure tms before the start of 5 consecutive days of aih treatment. we will measure tms within 24 hours of the final aih treatment.

Summary

This trial is testing if short bursts of low oxygen can help people with long-term, partial spinal cord injuries improve their ability to learn and perform movements.

Who is the study for?

This trial is for adults aged 18-70 with chronic, incomplete spinal cord injury (iSCI) at least one year post-injury. Participants must be medically stable with a doctor's clearance and able to take a step independently or with devices. Excluded are those with severe illnesses, heart or lung issues, ongoing physical therapy, untreated fractures or sores, metal head implants/pacemakers, recent concussions, pregnancy plans, seizures/epilepsy.

What is being tested?

The study investigates the effects of acute intermittent hypoxia (AIH), which involves brief periods of low oxygen levels on motor learning in people with iSCI. It compares AIH against a sham procedure to determine if it can improve movement control.

What are the potential side effects?

Potential side effects may include discomfort from wearing the hypoxia mask and risks associated with low oxygen such as headaches or dizziness. The exact side effects will depend on individual responses to hypoxia.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 70 years old.

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I have a spinal cord injury or disorder like MS, ALS, or a spinal tumor.

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I can walk at least one step on my own, with or without help from devices.

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My spinal cord injury is between my neck and lower back but I can still move.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with depression or a manic disorder.

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I have untreated painful bone or muscle issues, fractures, or pressure sores.

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I have had repeated episodes of sudden high blood pressure.

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I have had heart or lung problems in the past.

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I am experiencing severe illness or pain.

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I have a history of seizures or epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ we will measure asymmetry before the start of 5 consecutive days of aih treatment as baseline. we will measure asymmetry within 24 hours after the final aih treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~we will measure asymmetry before the start of 5 consecutive days of aih treatment as baseline. we will measure asymmetry within 24 hours after the final aih treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and we will measure asymmetry before the start of 5 consecutive days of aih treatment as baseline. we will measure asymmetry within 24 hours after the final aih treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Metabolic Power

Change in Step Length Asymmetry

Change in Step Time Asymmetry

+1 more

Secondary study objectives

Change Muscle Surface Electromyography

Change in Leg Kinematics

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Repetitive Acute Intermittent HypoxiaExperimental Treatment1 Intervention

5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals

Group II: SHAM Acute Intermittent HypoxiaPlacebo Group1 Intervention

5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for spinal cord injury (SCI) that focus on stimulating neuroplasticity and enhancing motor learning include repetitive acute intermittent hypoxia (AIH) and spinal cord stimulation. AIH involves exposing patients to short periods of low oxygen levels, which can promote neuroplasticity by increasing the production of growth factors and enhancing synaptic connections. This can lead to improved motor function and recovery. Spinal cord stimulation, on the other hand, uses electrical impulses to activate neural circuits below the level of injury, facilitating motor function and potentially improving voluntary movement. These treatments are crucial for SCI patients as they offer potential pathways to regain lost functions and improve quality of life by harnessing the body's ability to adapt and reorganize neural pathways.

Hyperbaric oxygen therapy of spinal cord injury.