Intermittent Hypoxia Elicits Prolonged Restoration of Motor Function in Human SCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-11-30

Brief Summary

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The goal of the study is to determine whether repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) will improve limb function after spinal cord injury. This idea stems from animal studies on respiration, in which investigators have shown that mild intermittent hypoxia improves breathing in spinally injured rats. These studies have shown that intermittent hypoxia induces spinal plasticity, strengthening neural connections and motor neuron function within the spinal cord. Exposure to mild intermittent hypoxia triggers a cascade of events, including increased production of key proteins and increased sensitivity of spinal cord circuitry necessary for improved breathing.

The ultimate goal of this research is to assess the potential of mild intermittent hypoxia as a therapeutic approach to stimulate recovery of limb function in human patients.

Detailed Description

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: The goal of the study is to determine whether repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) will improve limb function after spinal cord injury. This idea stems from animal studies on respiration, in which investigators have shown that mild intermittent hypoxia improves breathing in spinally injured rats. These studies have shown that intermittent hypoxia induces spinal plasticity, strengthening neural connections and motor neuron function within the spinal cord. Exposure to mild intermittent hypoxia triggers a cascade of events, including increased production of key proteins and increased sensitivity of spinal cord circuitry necessary for improved breathing.

The investigators initially hypothesize that daily exposure to intermittent hypoxia for 7 consecutive days will improve limb function in rats and in humans with chronic spinal injuries. First, the investigators will compare limb function in spinally-injured rats which receive mild intermittent hypoxia treatment with rats that did not. The investigators will measure grip strength and locomotor abilities in both groups before treatment and for several months after treatment. The investigators will also examine the spinal cords of these rats to look for the key proteins, which are indicators of spinal plasticity. The investigators will use this information to guide the treatment protocols when the investigators compare limb function in spinal-injured persons with and without intermittent hypoxia treatment.

The second hypothesis is that combining intermittent hypoxia with locomotor training will further improve limb function after spinal injury. To test this idea, the investigators will compare limb function in spinally-injured rats which have received combined intermittent hypoxia and treadmill training with rats which only received intermittent hypoxia or locomotor training alone. The investigators will examine key proteins in the spinal cords of these rats to determine whether the combination of hypoxia and training further alters these indicators of plasticity. The investigators will also compare limb function in spinally-injured humans who receive both intermittent hypoxia and locomotor treadmill training with those who receive either treatment alone.

The ultimate goal of this research is to assess the potential of mild intermittent hypoxia as a therapeutic approach to stimulate recovery of limb function in human patients.

Conditions

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Spinal Cord Injury

Keywords

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spinal cord injury walking low oxygen air strength

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low oxygen

Group Type EXPERIMENTAL

Acute intermittent hypoxia

Intervention Type OTHER

30 minutes of intermittent breathing low oxygen followed by walking on a body-weight support treadmill

Room Air

Group Type SHAM_COMPARATOR

Room air

Intervention Type OTHER

30 minutes of breathing room air followed by walking on a body-weight support treadmill

Interventions

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Acute intermittent hypoxia

30 minutes of intermittent breathing low oxygen followed by walking on a body-weight support treadmill

Intervention Type OTHER

Room air

30 minutes of breathing room air followed by walking on a body-weight support treadmill

Intervention Type OTHER

Other Intervention Names

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breathing low oxygen breathing room air

Eligibility Criteria

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Inclusion Criteria

* medical clearance to participate
* lesion below C5 and above T12 with non-progressive etiology
* classified as motor-incomplete
* injury greater than 12 months
* ambulatory with minimal assistance

Exclusion Criteria

* Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of cardiac or pulmonary complications)
* Pregnant women because of the unknown affects of AIH on pregnant women and fetus
* History of seizures, brain injury, and/or epilepsy
* Diagnosed with obstructive sleep apnea
* Undergoing concurrent physical therapy
* Any contraindications to EMG testing procedures (skin sensitivity)
* Any contraindications to passive movement of the limbs (e.g., joint immobility, hemodynamic instability)
* Score of \< 24 on Mini-Mental Exam

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Randy D. Trumbower

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Randy D Trumbower, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Shepherd Center

Atlanta, Georgia, United States

Site Status

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Hayes HB, Jayaraman A, Herrmann M, Mitchell GS, Rymer WZ, Trumbower RD. Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Neurology. 2014 Jan 14;82(2):104-13. doi: 10.1212/01.WNL.0000437416.34298.43. Epub 2013 Nov 27.

Reference Type DERIVED

PMID: 24285617 (View on PubMed)

Other Identifiers

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W81XWH-10-1-0832

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00035986a

Identifier Type: -

Identifier Source: org_study_id

Intermittent Hypoxia Elicits Prolonged Restoration of Motor Function in Human SCI

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Low oxygen

Acute intermittent hypoxia

Room Air

Room air

Interventions

Acute intermittent hypoxia

Room air

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Shirley Ryan AbilityLab

Shepherd Center, Atlanta GA

Northwestern University

University of Wisconsin, Madison

University of Saskatchewan

Emory University

Responsible Party

Randy D. Trumbower

Principal Investigators

Randy D Trumbower, PT, PhD

Locations

Shepherd Center

Rehabilitation Institute of Chicago

Countries

References

Hayes HB, Jayaraman A, Herrmann M, Mitchell GS, Rymer WZ, Trumbower RD. Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Neurology. 2014 Jan 14;82(2):104-13. doi: 10.1212/01.WNL.0000437416.34298.43. Epub 2013 Nov 27.

Related Links

Other Identifiers

W81XWH-10-1-0832

IRB00035986a