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Study Effects of Intermittent Hypoxia on Restoring Hand Function Following SCI

NCT01272336 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2016-01-26

No results posted yet for this study

Summary

The goal of the study is to examine the effects of repeated breathing episodes of mild intermittent hypoxia (reduced oxygen) training on hand strength and grasping ability following cervical spinal injury, and to determine whether these changes result in improved hand function. If so, such changes may indicate hypoxia-induced spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences), which could result in improvements in hand use for persons with spinal cord injury (SCI).

Conditions

  • Spinal Cord Injury

Interventions

DRUG

Acute Intermittent Hypoxia (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=0.09±0.02 (hypoxia) air for 15 minutes.Participants will receive treatment for up to seven visits.

OTHER

SHAM-Intermittent Room Air

This is a sham intervention to the AIH intervention. Participants will breath 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=0.21±0.02 (normoxia). Participants will receive treatment for up to seven visits.

Sponsors & Collaborators

  • University of Saskatchewan

    collaborator OTHER

  • University of Wisconsin, Madison

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • Randy D Trumbower, PT, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-08-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01272336 on ClinicalTrials.gov