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Phase 2 N=12 Randomized Quadruple-blind Treatment

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

Spinal Cord Injuries

Bottom Line

View on ClinicalTrials.gov: NCT02323698 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: 10 Meter Walk Time — -5.0; -4.9; -4.6; -5.5 Seconds

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Caffeine (Drug); AIH (Other); Placebo (Other); SHAM (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Spaulding Rehabilitation Hospital
Primary completion
Mar 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
10 Meter Walk Time		 -5.0; -4.9; -4.6; -5.5; -1.7; 0.9 —
SECONDARY
6 Minute Walk Test		 24.1; 17.1; 6.2; 23.7; 15.7; 9.2 —

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02323698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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