NCT07583498

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
22mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Mar 2028

Study Start

First participant enrolled

March 17, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 23, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

April 23, 2026

Last Update Submit

May 7, 2026

Conditions

Spinal Cord Injuries (SCI)

Keywords

HypoxiaSpasticityReflex

Outcome Measures

Primary Outcomes (1)

  • Change in reflex indentation threshold

    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

    Day 1 of Intervention

Secondary Outcomes (2)

  • Change in Modified Ashworth Scale - Elbow

    Day 1 of intervention

  • Grip Strength

    Day 1 of intervention

Study Arms (1)

AIH intervention

EXPERIMENTAL

In this Arm, participants will receive the Acute Intermittent Hypoxia Intervention. In this AIH, participants will breath alternating bouts of lowered oxygen and room air (approximately 60 seconds of each) for around 30 minutes.

Device: Acute Intermittent Hypoxia (AIH)

Interventions

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

AIH intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord InjuriesHypoxiaMuscle Spasticity

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic Manifestations

Study Officials

  • William Z Rymer, MD, PhD

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William Z Rymer, MD, PhD

CONTACT

312-238-3919w-rymer@northwestern.edu

Alexander Barry, MS

CONTACT

312-238-1435abarry@sralab.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director Single Motor Unit Lab

Study Record Dates

First Submitted

April 23, 2026

First Posted

May 13, 2026

Study Start

March 17, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Upon request, we will provide de-identified study data to researchers. The ICF and Protocol will be uploaded upon completion of study procedures

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
At conclusion of the study, for up to 3 years following study closure
Access Criteria
The study team will provide de-identified files with study data upon specific request.

Locations

US(1)