Clinical trial

The Effects of Intermittent Hypoxia on Leg Function in Human Spinal Cord Injury (Caffeine Substudy)

Name

2017P001940b

Description

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.

Trial arms

Trial start

2019-01-01

Estimated PCD

2021-03-19

Trial end

2022-02-19

Status

Completed

Phase

Early phase I

Treatment

Caffeine

Subjects will ingest capsules containing caffeine (up to 6mg/kg). Experiments will begin 30min after consumption to approximately coincide with peak plasma concentrations.Throughout the 30min wait time and experimentation, blood pressure and heart rate will be monitored.

Arms:

Caffeine/AIH, Caffeine/SHAM

Other names:

caffeine anhydrous

AIH

Participants will breathe intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of FIO2 (fraction of inspired oxygen) = 0.10±0.02 (hypoxia). Throughout experimentation, blood pressure and heart rate will be monitored.

Arms:

Caffeine/AIH, Placebo/AIH

Other names:

Acute intermittent hypoxia

Placebo

This is a placebo counterpart to the caffeine drug. Subjects will ingest capsules containing dextrose. Experiments will begin 30min after consumption to mimic the caffeine drug protocol. Throughout experimentation, blood oxygenation, blood pressure and heart rate will be monitored.

Arms:

Placebo/AIH

SHAM

This is a placebo counterpart to breathing intermittent low oxygen. Participants will breathe intermittent room air via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of FIO2 (fraction of inspired oxygen) = 0.21±0.02 (normoxia). Throughout experimentation, blood pressure and heart rate will be monitored.

Arms:

Caffeine/SHAM

Size

Primary endpoint

10 Meter Walk Time

Baseline, after intervention (day 5), and at follow-ups (one week and two weeks)

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Balanced design', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}

Updated at

2023-12-13

1 organization

1 product

1 indication

Organization

Spaulding Rehabilitation Hospital

Product

Caffeine

Indication

Spinal Cord Injuries