Impact of Intermittent Hypoxia and Prednisolone on Motor Performance in Persons With SCI

November 21, 2018 updated by: Zev Rymer, Shirley Ryan AbilityLab
The objective of this study is to examine the effects of mild acute intermittent hypoxia (AIH) in combination with an anti-inflammatory drug (i.e. prednisolone) on motor performance in persons with spinal cord injury (SCI).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Spinal cord lesion at the level of C4 or below.
  • Incomplete spinal cord injury ASIA (American Spinal Injury Association) Impairment Scale classification C or D. ASIA C or D classification requires that individuals have detectable motor function below the level of spinal injury and have preserved sensation of the sacral segments S4-S5 (anal sphincter).
  • Age between 18 and 65 years.
  • Medically stable with medical clearance to participate.
  • SCI due to non-progressive etiology.
  • More than 6 months since initial SCI. We plan to choose subjects greater that six months post-injury, to ensure minimal confounding effects of spontaneous neurological recovery during the experiments. This will mean that changes in motor performance are due to the interventions associated with the research study.
  • Subjects must have active and passive ROM at the ankle from 10 degrees dorsiflexion to 30 degrees plantar flexion, 0 to 120 degrees of knee flexion, 90 degrees of hip flexion, and 10 degrees of hip extension in order to be positioned correctly for motor performance testing.
  • Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  • Presence of severe medical illness, including cardiac disease, uncontrolled high blood pressure, restrictive or obstructive pulmonary disease, significant osteoporosis or history of fracture following SCI, or history of lower limb peripheral nerve injury.
  • Individuals with uncontrolled diabetes mellitus, unhealed decubitus ulcers, active heterotopic ossification, rheumatologic disease or inflammatory arthritis, presence of a deep venous thrombosis, cancer, or active infection will be excluded, as these conditions can cause systemic inflammation independent of spinal cord injury.
  • Patients may not be receiving any other investigational agents.
  • Individuals with tracheostomy, asthma, or recent or current pulmonary infection will be excluded.
  • Women who are pregnant or nursing will be excluded, as the potential effects of intermittent hypoxia on pregnant women and fetus are unknown.
  • Subjects will also be excluded if they are currently taking NSAIDs, steroids, or disease-modifying anti-rheumatic drugs (DMARDs). Participation is allowed if the subject and his/her physician agree to suspend all NSAIDs for a minimum of a 14-day washout period prior to study evaluation and for the duration of the study. Individuals taking oral steroids, DMARDs will be excluded from the study due to the potential risks of abruptly discontinuing these agents.
  • Individuals will be excluded if they have a history of severe adverse reaction or allergic response to prednisolone in the past, history of stomach or intestinal ulcers, bleeding problems, chronic kidney disease, drink more than 3 alcoholic beverages per day, or are currently taking blood thinners. Excluding these individuals will limit the potential for having an adverse reaction to the anti-inflammatory administered in the study.
  • Individuals receiving intrathecal baclofen will be excluded. Individuals prescribed medications other than intrathecal baclofen for alleviation of spastic motor behaviors will be excluded unless both the subject and his/her physician agree to cease all such medications for a 14-day minimum washout period prior to participation and for the duration of the study.
  • Individuals will be excluded if they are taking antifungal ointments, estradiols or estrogens, rifampin, phenytoin, barbiturates or bupropion as these drugs can potential interact with prednisolone. See "concomitant medications" section below.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prednisolone + Acute Intermittent Hypoxia
Other: Prednisolone + Acute Intermittent Hypoxia
Administration of oral prednisolone followed by 15, 60-second bouts of mild hypoxia
Placebo Comparator: Placebo + Acute Intermittent Hypoxia
Other: Placebo + Acute Intermittent Hypoxia
Administration of oral matching placebo followed by 15, 60-second bouts of mild hypoxia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Isometric Ankle Plantar Flexion strength
Time Frame: 60 minutes
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shirley Ryan AbilityLab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU00103487

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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