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NCT Number: NCT07583498

Spasticity in SCI Following Acute Intermittent Hypoxia

This study aims to observe the effects of administration of a breathing intervention (Acute Intermittent Hypoxia (AIH)) on spasticity (tightness) in individuals with incomplete Spinal Cord Injury. It is hypothesized that hypoxia will decrease the reflex threshold of the biceps brachii, indicating an increase in spasticity following the AIH.

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Key information

Conditions

Spinal Cord Injuries (SCI) Central Nervous System Diseases Hypoxia Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Alexander Barry, MS

CONTACT

[email protected]

312-238-1435

William z Rymer, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

In the case of incomplete traumatic spinal cord injury, it is know now that muscular strength improves quickly after AIH administration, and this Increase in voluntary strength lasts from three to six hours. The Increase in strength, coupled with demonstrated improvements in spinal cord neural plasticity, makes AIH administration a potentially valuable new therapeutic intervention. AIH initially acts by releasing serotonin in the central nervous system, enhancing persistent sodium uptake (via the motor neuron soma) and activating voltage-gated calcium channels in motor neuron dendrites. There are also other effects of serotonin on motor neuron excitable channels. One potential complication of hypoxia is linked to the changes in motor neuron excitability in humans with SCI.

These issues may be relevant to our potential work on the Therapeutic efficacy of AIH in persons with incomplete spinal cord injury. In other words, if individuals are highly spastic, it may indicate that their neuronal receptor sites are inaccessible, and increasing spinal cord serotonin levels may not be beneficial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18
  • Non-progressive spinal Cord injury at least 6 months prior
  • Level of injury between C1-C8
  • ISNCSCI ASIA classification C or D
  • Measurable Spasticity

Exclusion criteria

  • Pre-existing hypoxic pulmonary disease
  • Positive Covid-Pneumonia diagnosis within 1 year of visit
  • Uncontrolled hypertension >140/90 mmHg
  • Individuals who are currently pregnant/nursing or planning on becoming pregnant
  • Individuals with a tracheostomy or who utilize mechanical ventilation
  • A botulinum toxin injection to upper extremity musculature within the past 3 months
  • Currently taking Baclofen
  • Congestive Heart Failure
  • Cardiac arrhythmias
  • Uncontrolled diabetes mellitus
  • Chronic obstructive pulmonary disease
  • Emphysema
  • Severe Asthma
  • Previous myocardial infarction
  • Carotid/intracerebral artery stenosis
  • Orthopedic injuries or surgeries that impact the ability to use the upper extremity
  • History of Epilepsy

Treatment and study plan

Acute Intermittent Hypoxia (AIH)

Device

This intervention involves breathing lowered levels of oxygen for 60 seconds, alternating with 60 seconds of room air breathing. Participants will be monitored and observed during the entire session for any changes in vital signs

Primary outcomes

  1. Change in reflex indentation threshold

    Time frame: Day 1 of Intervention

    Similar to a tendon tap that a doctor may perform, this study uses an automated tendon tapper to measure the level of indentation needed to elicit a reflex in the bicep muscle. The aim is to observe any changes in reflex threshold following the AIH intervention

Secondary outcomes

  1. Change in Modified Ashworth Scale - Elbow

    Time frame: Day 1 of intervention

    The modified Ashworth scale is a measure of Spasticity, performed by a trained administrator. This test involves rapidly rotating the participant's arm and feeling the spastic muscle response. This assessment is scored from 0 to 4, with 0 indicating no spasticity, and 4 indicating a fully contracted limb

  2. Grip Strength

    Time frame: Day 1 of intervention

    Using a handheld dynamometer, maximum grip strength of participants will be measured

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Barry, MS

CONTACT

[email protected]

312-238-1435

William Z Rymer, MD, PhD

CONTACT

[email protected]

312-238-3919

Sponsors and collaborators

Lead sponsor

Zev Rymer

Other

Registry information

Official study title

Does the Administration of Acute Intermittent Hypoxia in Persons With Chronic Spinal Cord Injury Make Spasticity Worse?

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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