Effects of Caffeine and Intermittent Hypoxia on Leg Function in Human Spinal Cord Injury

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) is a safe and effective treatment strategy to promote meaningful functional recovery in persons with chronic spinal cord injury (SCI). The goal of the study is to understand how caffeine may augment the effects of intermittent hypoxia on motor function and spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences) following SCI.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Spaulding Rehabilitation Hospital
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Caffeine

Criteria

Inclusion Criteria:

• age 18 and 75 years (the latter to reduce likelihood of heart disease)

• medical clearance to participate

• lesion at or below C2 and above L5 with non-progressive etiology

• classified as motor-incomplete with visible volitional leg movement

• injury greater than 6 months

• ability to advance one step overground without human assistance

Exclusion Criteria:

• Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of pulmonary complications)

• Pregnant women because of the unknown affects of AIH on pregnant women and fetus

• History of seizures, brain injury, and/or epilepsy

• Undergoing concurrent physical therapy

• Diabetes

• Cirrhosis

• Caffeine and/or NSAID allergies or intolerances