Effects of Caffeine and Intermittent Hypoxia on Leg Function in Human Spinal Cord Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 2/2/2019 |
| Start Date: | October 2014 |
| End Date: | May 2020 |
| Contact: | Randy D Trumbower, PT, PhD |
| Email: | randy.trumbower@mgh.harvard.edu |
| Phone: | (617) 952-6951 |
The Effects of Intermittent Hypoxia on Leg Function in Human Spinal Cord Injury (Caffeine Substudy)
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.
(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.
The investigators will examine the effects of acute intermittent hypoxia (AIH) as a possible
therapeutic intervention to promote functionally useful motor recovery. In this sub-study,
the investigators will assess changes in leg motor function in response to repetitive AIH
with and without caffeine.
Participants will receive caffeine+AIH, placebo+AIH, caffine+SHAM in a randomized order.
Before each intervention round, subjects will be asked to avoid caffeine-containing
substances for 48 hrs (> 5* half-life of ~7 hrs) prior to arrival to control for baseline
plasma levels of caffeine. Subjects will then ingest capsules containing either placebo
(dextrose) or caffeine (up to 6mg/kg). Capsules will be prepared by Johnson Compounding &
Wellness. Blood samples will be collected before and after the breathing intervention to
assess caffeine concentrations within the body.
During and after each intervention, both the rate and extent of magnitude changes in
voluntary and involuntary muscle response behaviors important for walking will be compared
between interventions within participants. Repeated measurements will be collected on all
subjects that participate in the multiple interventions.
therapeutic intervention to promote functionally useful motor recovery. In this sub-study,
the investigators will assess changes in leg motor function in response to repetitive AIH
with and without caffeine.
Participants will receive caffeine+AIH, placebo+AIH, caffine+SHAM in a randomized order.
Before each intervention round, subjects will be asked to avoid caffeine-containing
substances for 48 hrs (> 5* half-life of ~7 hrs) prior to arrival to control for baseline
plasma levels of caffeine. Subjects will then ingest capsules containing either placebo
(dextrose) or caffeine (up to 6mg/kg). Capsules will be prepared by Johnson Compounding &
Wellness. Blood samples will be collected before and after the breathing intervention to
assess caffeine concentrations within the body.
During and after each intervention, both the rate and extent of magnitude changes in
voluntary and involuntary muscle response behaviors important for walking will be compared
between interventions within participants. Repeated measurements will be collected on all
subjects that participate in the multiple interventions.
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 T12 with non-progressive etiology
- classified as motor-incomplete with visible volitional leg movement
- injury greater than 1 year
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
We found this trial at
1
site
1575 Cambridge Street
Cambridge, Massachusetts 02138
Cambridge, Massachusetts 02138
Phone: 617-952-6951
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