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Trial record 1 of 1 for:    NCT02323698
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Effects of Caffeine and Low Oxygen Therapy on Leg Function in Human Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02323698
Recruitment Status : Recruiting
First Posted : December 23, 2014
Last Update Posted : December 4, 2017
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Foundation Wings For Life
Information provided by (Responsible Party):
Randy Trumbower, PT, PhD, Harvard Medical School

Brief 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Dietary Supplement: Caffeine Other: AIH Dietary Supplement: Placebo Phase 1 Phase 2

Detailed Description:

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 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. Saliva samples will be collected before and after the breathing intervention using a standard passive drool protocol to assess caffeine concentrations within the body. The subject will be asked to collect saliva in their mouth and drool into a vial.

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Intermittent Hypoxia on Leg Function in Human Spinal Cord Injury (Caffeine Substudy)
Study Start Date : October 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Caffeine/AIH
Subjects with chronic, motor-incomplete SCI receive Caffeine and AIH
Dietary Supplement: Caffeine
Subjects will ingest capsules containing caffeine (up to 6mg/kg). Experiments will begin 60min after consumption to approximately coincide with peak plasma concentrations.Throughout the 60min wait time and experimentation, blood pressure and heart rate will be monitored.

Other: AIH
Participants will breath 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) = 0.09±0.02 (hypoxia).
Other Name: Acute intermittent hypoxia

Active Comparator: Placebo/AIH
Subjects with chronic, motor-incomplete SCI receive Placebo and AIH
Other: AIH
Participants will breath 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) = 0.09±0.02 (hypoxia).
Other Name: Acute intermittent hypoxia

Dietary Supplement: Placebo
This is a placebo counterpart to the caffeine drug. Subjects will ingest capsules containing dextrose. Experiments will begin 60min after consumption to mimic the caffeine drug protocol.Throughout the 60min wait time and experimentation, blood pressure and heart rate will be monitored.




Primary Outcome Measures :
  1. Change in overground walking speed [ Time Frame: Baseline, immediately after intervention (day 1 and day 5), and at follow-ups (one week and two weeks) ]
    Speed will be assessed by the time required to walk 10 meters (10MWT).


Secondary Outcome Measures :
  1. Change in muscle strength [ Time Frame: Baseline, immediately after intervention (day 1 and day 5), and at follow-ups (one week and two weeks) ]
    Ankle strength will be assessed by the maximum isometric plantar flexion torque produced by the ankle and measured by a 6 degrees-of-freedom (DOF) load cell.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323698


Contacts
Contact: Randy D Trumbower, PT, PhD (617) 952-6951 randy.trumbower@mgh.harvard.edu
Contact: Lorna Brown, DPT (617) 952-6950 labtrumbower@gmail.com

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Randy D Trumbower, PT, PhD    617-952-6951    randy.trumbower@mgh.harvard.edu   
Contact: Lorna Brown, DPT    (617) 952-6950    labtrumbower@gmail.com   
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Foundation Wings For Life
Investigators
Principal Investigator: Randy D Trumbower, PT, PhD Harvard Medical School

Responsible Party: Randy Trumbower, PT, PhD, Assistant Professor, Harvard Medical School
ClinicalTrials.gov Identifier: NCT02323698     History of Changes
Other Study ID Numbers: 2017P001940b
1R01HD081274 ( U.S. NIH Grant/Contract )
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017

Keywords provided by Randy Trumbower, PT, PhD, Harvard Medical School:
acute intermittent hypoxia
incomplete spinal cord injury

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents