Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05183113
Other study ID # SP0051925
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 20, 2019
Est. completion date July 30, 2023

Study information

Verified date September 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study uses Magnetic Resonance Imaging to image the brain and spinal cord before and after an Intermittent Hypoxia intervention. Acquiring these scans in patients with chronic cervical spinal cord injury and uninjured controls will enable characterization of changes in neurovascular physiology caused by this promising new therapy.


Description:

Acute intermittent hypoxia (AIH) is an emerging, safe technique for facilitating neural plasticity in individuals with chronic spinal cord injury (SCI), demonstrating significant transient improvements in respiratory function, plantar flexion, locomotor function, and hand dexterity and strength. Although these studies observe some degree of success eliciting plasticity, we lack a framework for systematic optimization of the AIH protocol for individual patients. Better understanding of what physiological mechanisms drive AIH-induced neural plasticity in humans will directly inform the development of AIH as an effective treatment option in chronic SCI. This study applies magnetic resonance imaging (MRI) to test how AIH influences vascular and neural properties of the brain and spinal cord. Individuals with SCI and uninjured participants will be recruited to undergo two MRI scan sessions on one day. In between these scan sessions, participants will undergo a single 30-minute session of AIH. In each scan session, functional MRI will assess AIH-induced changes in neural activation patterns during motor tasks (unilateral isometric hand grasping tasks) and vascular reactivity to breath hold tasks (transient hypocapnia to induce vasodilation). Additional structural scans will be acquired to aid in image analysis.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date July 30, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: All participants must meet the following inclusion criteria: - Between the ages of 18-60 years - Safe to be scanned using MRI - Able to communicate in English - Ability to sign informed consent In addition, the participants recruited with SCI must meet the following criteria: - History of a traumatic spinal cord injury, inclusive of levels C2-T1 - At least 6 months since onset of spinal cord injury - Cause of the spinal cord injury was non-progressive - Ability to complete and comply with information within the informed consent - Ability to close and open at least one hand without assistance Exclusion Criteria: - MRI contraindications as indicated on MRI safety screening form - Subjects with pacemakers, cochlear (in the ear) implants, or aneurysm clips or subjects who have worked with metal - Women who are currently pregnant, nursing, or planning on becoming pregnant - Individuals with severe claustrophobia - Subjects unwilling or unable to give written informed consent in English - Prisoners - Frequent smokers (greater than 5 cigarettes per day) - Blood pressure greater than 160/110 or less than 85/55. - Individuals who report headaches, feeling dizzy or light-headed, or have heart palpitations on the day of the study. - Diagnosis of any of the following comorbid conditions: congestive heart failure, cardiac arrhythmias, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, emphysema, severe asthma, previous myocardial infraction or known carotid/intracerebral artery stenosis, presence of active deep venous thrombosis, or cancer. - Individuals who utilize mechanical ventilation or have a tracheostomy - Individuals who utilize an intrathecal baclofen pump - Orthopedic injury affecting upper extremities - Currently participating in any other hypoxia related study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Acute Intermittent Hypoxia
Participants will wear a non-rebreathing face mask and alternate between breathing 9% O2 gas mixture for up to 1 minute, or until the target SpO2 of 85 percent is reached, and normal room air (21 percent O2) until 2 minutes are complete. This cycle will be repeated 15 times, resulting in a 30-minute protocol.

Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Northwestern University Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

References & Publications (5)

Golder FJ, Mitchell GS. Spinal synaptic enhancement with acute intermittent hypoxia improves respiratory function after chronic cervical spinal cord injury. J Neurosci. 2005 Mar 16;25(11):2925-32. doi: 10.1523/JNEUROSCI.0148-05.2005. — View Citation

Hayes HB, Jayaraman A, Herrmann M, Mitchell GS, Rymer WZ, Trumbower RD. Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Neurology. 2014 Jan 14;82(2):104-13. doi: 10.1212/01.WNL.0000437416.34298.43. Epub 2013 Nov 27. — View Citation

Li Y, Lucas-Osma AM, Black S, Bandet MV, Stephens MJ, Vavrek R, Sanelli L, Fenrich KK, Di Narzo AF, Dracheva S, Winship IR, Fouad K, Bennett DJ. Pericytes impair capillary blood flow and motor function after chronic spinal cord injury. Nat Med. 2017 Jun;23(6):733-741. doi: 10.1038/nm.4331. Epub 2017 May 1. — View Citation

Trumbower RD, Hayes HB, Mitchell GS, Wolf SL, Stahl VA. Effects of acute intermittent hypoxia on hand use after spinal cord trauma: A preliminary study. Neurology. 2017 Oct 31;89(18):1904-1907. doi: 10.1212/WNL.0000000000004596. Epub 2017 Sep 29. — View Citation

Trumbower RD, Jayaraman A, Mitchell GS, Rymer WZ. Exposure to acute intermittent hypoxia augments somatic motor function in humans with incomplete spinal cord injury. Neurorehabil Neural Repair. 2012 Feb;26(2):163-72. doi: 10.1177/1545968311412055. Epub 2011 Aug 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary BOLD fMRI activation in motor cortex during isometric hand grip tasks Assess AIH-induced changes in %BOLD activation within the left and right motor cortices during unilateral isometric hand grasping tasks targeting submaximal force levels with real-time feedback. Immediately before and ~ 1-hour after AIH on the same day
Primary BOLD fMRI vascular reactivity to a breath-hold task Measurements of breath-hold induced vasodilation (vascular reactivity, in units of %BOLD/mmHg end-tidal CO2) acquired via functional MRI in the brain and spinal cord. Immediately before and ~ 1-hour after AIH on the same day
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06321172 - Muscle and Bone Changes After 6 Months of FES Cycling N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05484557 - Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury N/A
Suspended NCT05542238 - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury N/A
Recruiting NCT05503316 - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System N/A
Not yet recruiting NCT05506657 - Early Intervention to Promote Return to Work for People With Spinal Cord Injury N/A
Recruiting NCT04105114 - Transformation of Paralysis to Stepping Early Phase 1
Recruiting NCT03680872 - Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System N/A
Completed NCT04221373 - Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation N/A
Completed NCT00116337 - Spinal Cord Stimulation to Restore Cough N/A
Completed NCT03898700 - Coaching for Caregivers of Children With Spinal Cord Injury N/A
Recruiting NCT04881565 - Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES) N/A
Recruiting NCT04883463 - Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury N/A
Active, not recruiting NCT04864262 - Photovoice for Spinal Cord Injury to Prevent Falls N/A
Recruiting NCT04007380 - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI N/A
Active, not recruiting NCT04544761 - Resilience in Persons Following Spinal Cord Injury
Terminated NCT03170557 - Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation N/A
Completed NCT03220451 - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients N/A
Recruiting NCT04811235 - Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial N/A
Recruiting NCT04736849 - Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury N/A