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Trial record 12 of 25 for:    spinal cord injury AND NICHD

Effects of Caffeine and Intermittent Hypoxia 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 : January 31, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Randy Trumbower, PT, PhD, Spaulding Rehabilitation Hospital

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 Drug: Caffeine Other: AIH Other: Placebo Other: SHAM 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, 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Balanced design
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 then AIH
Drug: 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 Name: caffeine anhydrous

Other: 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).
Other Name: Acute intermittent hypoxia

Active Comparator: Placebo/AIH
Subjects with chronic, motor-incomplete SCI receive Placebo then AIH
Other: 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).
Other Name: Acute intermittent hypoxia

Other: 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.

Active Comparator: Caffeine/SHAM
Subjects with chronic, motor-incomplete SCI receive Caffeine then SHAM
Drug: 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 Name: caffeine anhydrous

Other: 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).




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



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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
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Contact: Randy D Trumbower, PT, PhD (617) 952-6951 randy.trumbower@mgh.harvard.edu
Contact: Stella Barth, BA (617) 952-6822 SBARTH@PARTNERS.ORG

Locations
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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: Stella Barth, BA    (617) 952-6822    SBARTH@PARTNERS.ORG   
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Randy D Trumbower, PT, PhD Harvard Medical School

Additional Information:
Publications:
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Responsible Party: Randy Trumbower, PT, PhD, Assistant Professor, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02323698     History of Changes
Other Study ID Numbers: 2017P001940b
5R01HD081274 ( U.S. NIH Grant/Contract )
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Randy Trumbower, PT, PhD, Spaulding Rehabilitation Hospital:
hypoxia
spinal cord injury
rehabilitation
strength
walk
function
low oxygen

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Trauma, Nervous System
Hypoxia
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
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