Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair

Who is this study for? Patients with Cervical Spinal Cord Injury
Status: Recruiting
Location: See location...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

Contusive cervical spinal cord injury (cSCI) impairs upper limb function (reach-and-grasp) which limits daily-life activities and thus decreases the quality of life. Promoting neuroplasticity may support upper limb recovery after SCI. Repetitive exposure to acute intermittent hypoxia (rAIH) combined with motor training promotes recovery of motor function after SCI; however, the overall effects of rAIH/training are limited. The investigators will use an adult rat model of long-term contusive cSCI to study novel approaches to enhance the effect of rAIH/training on forelimb function and study the neuronal substrate underlying the effects. The findings will be used to direct the development of more effective rAIH/training approaches for people with contusive, functionally incomplete, cSCI. Because deficits in upper limb function are a major problem after stroke, amyotrophic lateral sclerosis, multiple sclerosis, and other motor disorders, this work may also be relevant for patients with other types of central nervous system (CNS) lesions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
View:

• Male and females Veterans between 18-85 years

• Chronic cSCI (1 yr of injury)

• Cervical injury at C8 or above

• Sensory function: impaired (score of 1) but not absent (score of 0) or intact (score of 2) innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) sensory scores

• Motor function: Able to grasp small objects with one hand and able to perform a visible precision grasp between the index finger and thumb

• Motor scores ISNCSCI: 1 to 4 but not 5 on finger flexors and finger abductors on the hand tested.

⁃ These criteria were selected to ensure that hand impairment will not interfere with the ability to perform training and proposed tests

• Male and females (18-80 years)

• Right handed

• Able to complete precision and power grips

Locations
United States
Illinois
Edward Hines Jr. VA Hospital, Hines, IL
RECRUITING
Hines
Contact Information
Primary
Martin Oudega, PhD
moudega@sralab.org
(305) 575-7000
Backup
Monica A Perez, PhD
mperez04@sralab.org
(312) 238-2886
Time Frame
Start Date: 2020-02-25
Estimated Completion Date: 2026-02-05
Participants
Target number of participants: 90
Treatments
Experimental: hypoxia plus training
combined hypoxia treatment with exercise training
Sham_comparator: sham hypoxia plus training
combined sham hypoxia treatment with exercise training
Experimental: hypoxia plus training plus NMDA agonist
combined hypoxia treatment with exercise training and with NMDA agonist treatment
Placebo_comparator: hypoxia plus training plus sham NMDA agonist
combined hypoxia treatment with exercise training and with sham NMDA agonist treatment
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov