NCT01272336

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

2.7 years

First QC Date

January 4, 2011

Last Update Submit

January 23, 2016

Conditions

Spinal Cord Injury

Keywords

spinal cord injury, low oxygen, strength, motor control

Outcome Measures

Primary Outcomes (1)

  • Hand grasp

    1 week

Secondary Outcomes (1)

  • Grip strength

    1 week

Study Arms (2)

AIH/Sham

ACTIVE COMPARATOR

Subjects with chronic, motor-incomplete SCI receive AIH and then SHAM

Drug: Acute Intermittent Hypoxia (AIH)Other: SHAM-Intermittent Room Air

Sham/AIH

ACTIVE COMPARATOR

Subjects with chronic, motor-incomplete SCI receive SHAM and then AIH

Drug: Acute Intermittent Hypoxia (AIH)Other: SHAM-Intermittent Room Air

Interventions

Acute Intermittent Hypoxia (AIH)DRUG

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.

Also known as: Hypoxia air mixture
AIH/ShamSham/AIH
SHAM-Intermittent Room AirOTHER

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.

Also known as: Room air mixture
AIH/ShamSham/AIH

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 and 65 years
  • medical clearance to participate
  • lesion below the 5th cervical spinous process (C5) and above the first thoracic spinous process (T1) with non-progressive etiology
  • classified as motor-incomplete injury greater than 12 months
  • independent breathing

You may not qualify if:

  • 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 acute intermittent hypoxia on pregnant women and fetus
  • Concomitant acquired brain injury
  • 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
  • Score of \< 24 on Mini-Mental Exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory Center for Rehabilitation Medicine

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • Trumbower RD, Hayes HB, Mitchell GS, Wolf SL, Stahl VA. Effects of acute intermittent hypoxia on hand use after spinal cord trauma: A preliminary study. Neurology. 2017 Oct 31;89(18):1904-1907. doi: 10.1212/WNL.0000000000004596. Epub 2017 Sep 29.

    PMID: 28972191DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Randy D Trumbower, PT, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 7, 2011

Study Start

December 1, 2010

Primary Completion

August 1, 2013

Study Completion

October 1, 2015

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

US(1)