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Spasticity in SCI Following Acute Intermittent Hypoxia

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07583498
Enrollment
10
Registered
2026-05-13
Start date
2026-03-17
Completion date
2028-03-01
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries (SCI)

Keywords

Hypoxia, Spasticity, Reflex

Brief summary

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.

Detailed description

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.

Interventions

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

Sponsors

Zev Rymer
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in reflex indentation thresholdDay 1 of InterventionSimilar 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

MeasureTime frameDescription
Change in Modified Ashworth Scale - ElbowDay 1 of interventionThe 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
Grip StrengthDay 1 of interventionUsing a handheld dynamometer, maximum grip strength of participants will be measured

Countries

United States

Contacts

CONTACTWilliam Z Rymer, MD, PhD
w-rymer@northwestern.edu312-238-3919
CONTACTAlexander Barry, MS
abarry@sralab.org312-238-1435
PRINCIPAL_INVESTIGATORWilliam Z Rymer, MD, PhD

Shirley Ryan AbilityLab

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026