Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Timing and Dosage of Acute Intermittent Hypoxia in Persons With SCI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774043
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Milap Sandhu, Shirley Ryan AbilityLab

Brief Summary:
This study will utilize short duration and mild levels of reduced oxygen (hypoxia) to induce spinal plasticity while evaluating the appropriate timing schedule for this intervention, as well as, the effects of superimposing sessions of a therapy, in individuals with chronic incomplete SCI. Our aim is to establish the time-course of outcome improvement and decay following a single session or multiple sessions of AIH therapy.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Acute Intermittent Hypoxia Other: Sham Acute Intermittent Hypoxia Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Timing and Dosage Parameters of Acute Intermittent Hypoxia in Individuals With Spinal Cord Injury.
Study Start Date : May 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single session of Acute Intermittent Hypoxia (AIH) Other: Acute Intermittent Hypoxia
Patients will breath 9%-11% oxigen for 1.5 minutes interspersed with 1.5 minutes of 21% oxigen (normoxia), 15 times for a total of 45 minutes.

Placebo Comparator: Single session of Sham Acute Intermittent Hypoxia (Sham AIH) Other: Sham Acute Intermittent Hypoxia
Patients will breath 21% oxigen for 1.5 minutes interspersed with 1.5 minutes of room air, 15 times for a total of 45 minutes.

Experimental: Two successive sessions of AIH Other: Acute Intermittent Hypoxia
Patients will breath 9%-11% oxigen for 1.5 minutes interspersed with 1.5 minutes of 21% oxigen (normoxia), 15 times for a total of 45 minutes.

Placebo Comparator: Two successive sessions of Sham AIH Other: Sham Acute Intermittent Hypoxia
Patients will breath 21% oxigen for 1.5 minutes interspersed with 1.5 minutes of room air, 15 times for a total of 45 minutes.




Primary Outcome Measures :
  1. Change in grip strength [ Time Frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours ]
    A dynamometer measures maximum gross grasp (kglb) averaged over three attempts with each hand. The minimum possible value of zero kg lb will be assigned when the participant cannot actively flex the fingers or grasp the dynamometer. Standard position includes the participant in a supported sitting position, with shoulder in adducted and in neutral rotation and the elbow flexed at 90 degrees. The forearm should be in neutral rotation. The arm should not be supported by an arm rest or research personnel.

  2. Pinch Strength [ Time Frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours ]
    A pinch gauge measures maximum pinch force (kglb) averaged over three attempts with each hand. The minimum possible value of zero kg will be assigned when the participant cannot actively squeeze the pinch meter between the thumb and index finger. Standard position includes the participant in a supported sitting position, with shoulder in adducted and in neutral rotation and the elbow flexed at 90 degrees. The gauge will be placed between the thumb and lateral surface of the index finger (lateral pinch).

  3. 9 Hole Peg Test [ Time Frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours ]
    A measure of finger dexterity involving the placement of pegs from a container to holes on a board, and subsequent removal, as quickly as possible. The total number of seconds until task completion is recorded, as measured by when the participant touches the first peg to when the last peg is placed back into the container.

  4. Box and Blocks test [ Time Frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours ]
    A measure of manual dexterity that requires repeatedly moving 1-inch blocks from one side of a box to another in 60 seconds



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Spinal cord lesion at level of C3 to T1
  2. Individuals with a history of incomplete spinal cord injury, classified as ASIA C or D
  3. Individuals must be at least 6 months status post injury
  4. Individuals must be between the ages of 18-70 years inclusive, male or female
  5. Spinal cord injury must be secondary to a non-progressive etiology
  6. Individuals must be medically stable.
  7. Able to comply with protocol/study requirements
  8. Not currently (>2 weeks) taking any medications for spasticity management.

Exclusion Criteria:

  1. Recent change in the use of narcotic, anti-inflammatory or pain medication
  2. Unstable medical conditions or any other clinical observation that may affect the candidate's performance, health, safety or the ability to participate in the study, as determined by the treating therapist
  3. History of sleep apnea
  4. Active participation in another movement research study or therapy program
  5. Anti-spasticity drug injection less than 3 months, prior to beginning treatment
  6. Musculoskeletal pain that interferes with participation in study
  7. Women who are currently, may be or planning on becoming pregnant

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): NCT03774043


Contacts
Layout table for location contacts
Contact: Milap Sandhu, PT, PhD 3122386529 m-sandhu@northwestern.edu
Contact: Sofia Anastasopoulos sanastasop@ric.org

Locations
Layout table for location information
United States, Illinois
Rehabilitation Institute of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Milap S Sandhu, PT, PhD    312-238-6529    m-sandhu@northwestern.edu   
Sponsors and Collaborators
Shirley Ryan AbilityLab

Layout table for additonal information
Responsible Party: Milap Sandhu, Principal Investigator, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT03774043     History of Changes
Other Study ID Numbers: STU00202027
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Hypoxia
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Signs and Symptoms, Respiratory
Signs and Symptoms