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A Multicenter Clinical Trial to Evaluate the Effectiveness of Intermittent Hypoxia Therapy in Individual With Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03433599
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Monica Perez, University of Miami

Brief Summary:
The overall objective of this project is to investigate the effectiveness of daily acute intermittent hypoxia therapy (dAIH), coupled with massed practice training, to improve upper-extremity function in individuals with chronic incomplete cervical spinal cord injury (SCI).

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Daily Acute Intermittent Hypoxia Other: Normal Room Air Other: Training by Research Staff Other: Training with an Exoskeleton Rapael glove Other: No training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Multi-Center Clinical Trial to Evaluate the Effectiveness of Intermittent Hypoxia Therapy in Individuals With Spinal Cord Injury
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dAIH + Rapael Glove
Participants will receive daily acute Intermittent Hypoxia (dAIH) and training with an Exoskeleton Rapael glove.
Other: Daily Acute Intermittent Hypoxia
Participants will be fitted with a mask that will be placed over mouth and nose. Tubing will be attached to the front of the mask. The session will last approximately 30-45 minutes with 60-90 seconds of lower oxygen (tubing attached, 9-10% oxygen level), alternating with 60-90 sec of normal room air (no tubing attached).

Other: Training with an Exoskeleton Rapael glove
These training sessions will last approximately 45 minutes, with additional time for set up of the device. During these sessions, the participant will be asked to complete a variety of activities related to arm, pinch, and grip function. The activities will be made more or less difficult based on the ability of the participant to successfully complete the activity.

Active Comparator: dAIH + training by research staff
Participants will receive daily acute Intermittent Hypoxia (dAIH) and training by research staff.
Other: Daily Acute Intermittent Hypoxia
Participants will be fitted with a mask that will be placed over mouth and nose. Tubing will be attached to the front of the mask. The session will last approximately 30-45 minutes with 60-90 seconds of lower oxygen (tubing attached, 9-10% oxygen level), alternating with 60-90 sec of normal room air (no tubing attached).

Other: Training by Research Staff
Training sessions will last for approximately 45 minutes, with additional time for set up. During these sessions, participants will be asked to complete a variety of tasks related to general arm/hand movement, pinch, and grip. The number of repetitions will be monitored and adjust the difficulty to ensure appropriate task difficulty.

Active Comparator: dAIH
Participants will receive daily acute Intermittent Hypoxia (dAIH) and no training.
Other: Daily Acute Intermittent Hypoxia
Participants will be fitted with a mask that will be placed over mouth and nose. Tubing will be attached to the front of the mask. The session will last approximately 30-45 minutes with 60-90 seconds of lower oxygen (tubing attached, 9-10% oxygen level), alternating with 60-90 sec of normal room air (no tubing attached).

Other: No training
The participants will not be receiving any training.

Sham Comparator: Room Air + Rapael Glove
Participants will receive normal room air and training with an Exoskeleton Rapael glove.
Other: Normal Room Air
Participants will be fitted with a mask that will be placed over mouth and nose. Tubing will be attached to the front of the mask. The session will last approximately 30-45 minutes with 60-90 seconds of normal room air (with tubing attached to the mask) and 60-90 sec of normal room air (without the tubing attached to the mask).

Other: Training with an Exoskeleton Rapael glove
These training sessions will last approximately 45 minutes, with additional time for set up of the device. During these sessions, the participant will be asked to complete a variety of activities related to arm, pinch, and grip function. The activities will be made more or less difficult based on the ability of the participant to successfully complete the activity.

Sham Comparator: Room Air + training by staff
Participants will receive normal room air and training by research staff.
Other: Normal Room Air
Participants will be fitted with a mask that will be placed over mouth and nose. Tubing will be attached to the front of the mask. The session will last approximately 30-45 minutes with 60-90 seconds of normal room air (with tubing attached to the mask) and 60-90 sec of normal room air (without the tubing attached to the mask).

Other: Training by Research Staff
Training sessions will last for approximately 45 minutes, with additional time for set up. During these sessions, participants will be asked to complete a variety of tasks related to general arm/hand movement, pinch, and grip. The number of repetitions will be monitored and adjust the difficulty to ensure appropriate task difficulty.

Sham Comparator: Room air
Participants will receive normal room air and no training.
Other: Normal Room Air
Participants will be fitted with a mask that will be placed over mouth and nose. Tubing will be attached to the front of the mask. The session will last approximately 30-45 minutes with 60-90 seconds of normal room air (with tubing attached to the mask) and 60-90 sec of normal room air (without the tubing attached to the mask).

Other: No training
The participants will not be receiving any training.




Primary Outcome Measures :
  1. Change in grip Strength [ Time Frame: baseline, 1st week, 2nd week, 4th week, 8th week, and 12th week. ]
    Grip strength will be measured using a hand-held dynamometer, with an average force ( measured in Kdynes) taken over the course of three trials. A rest break is provided between trials. Strength testing will be completed bilaterally.

  2. Change in coordination/ dexterity [ Time Frame: baseline, 1st week, 2nd week, 4th week, 8th week, and 12th week. ]
    9-Hole Peg Test is a standardized assessment of coordination/ dexterity. It is one of the most frequently utilized outcome measures. This test will be completed bilaterally, if possible. the total time in seconds is recorded.


Secondary Outcome Measures :
  1. Change in pinch strength [ Time Frame: baseline, 1st week, 2nd week, 4th week, 8th week, and 12th week. ]
    Pinch strength will be assessed using a digital pinch gauge (unit of Force= Newton). The minimum value of zero will be assigned when a participant cannot actively squeeze the pinch meter between the thumb and index finger. The mean value of total of 3 trials will be assessed, with a rest break provided between trials.

  2. Change in elbow strength [ Time Frame: baseline, 1st week, 2nd week, 4th week, 8th week, and 12th week. ]
    Isometric elbow strength will be measured using a dynamometer ( measured in Kdynes). A total of three trials will be taken on each side, with a rest break between trials. The average of the three trials will be recorded.

  3. Change in manual dexterity [ Time Frame: baseline, 1st week, 2nd week, 4th week, 8th week, and 12th week. ]
    Box and Blocks test evaluates manual dexterity, and focuses on the amount of times (count/seconds) an individual can successfully translate 1-inch blocks from one side of a box to another, within a 60 second time point.

  4. Change in impairment measure [ Time Frame: baseline, 1st week, 2nd week, 4th week, 8th week, and 12th week. ]
    The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) is a clinical impairment measure used to evaluate sensory and motor hand function in individuals with cervical spinal cord injuries. Specifically, it evaluates the domains of sensation, strength, quality of different grip patterns and the ability to complete a variety of functional tasks.

  5. Change of functional limitations [ Time Frame: baseline, 1st week, 2nd week, 4th week, 8th week, and 12th week. ]
    The Capabilities of Upper Extremity Questionnaire (CUE-Q) is a 32-item questionnaire that assesses the difficulty in performing certain motions or activities with the upper extremities. This questionnaire was designed to assess the functional limitations in individuals with spinal cord injury, and is recommended for use in individuals with chronic (>6 months) spinal cord injury.

  6. Change in muscle strength [ Time Frame: baseline, 1st week, 2nd week, 4th week, 8th week, and 12th week. ]
    Isometric manual muscle testing will be completed for major muscle groups of the upper extremity, with the participant in either a supine or seated position.

  7. Change in resistance [ Time Frame: baseline, 1st week, 2nd week, 4th week, 8th week, and 12th week. ]

    Spasticity will be assessed through the use of the Modified Ashworth Scale. This scale allows for characterization of increases in muscle tone, from a slight increase in tone to complete limb rigidity.

    0 = No increase in muscle tone

    1 = Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension

    1+ = Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM) 2 = More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 = Considerable increase in muscle tone passive, movement difficult 4 = Affected part(s) rigid in flexion or extension




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • History of motor incomplete spinal cord injury (AISA C and D) at or below C3, and at or above T1 from a non-progressive etiology.
  • Between the ages of 18 - 70 years.
  • At least 6 months since onset of spinal cord injury.
  • Ability to close and open at least one hand without assistance, without significant use of tenodesis.
  • Ability to understand and the willingness to sign an informed consent.
  • Not currently (>2 weeks) taking any medications for spasticity management.
  • At least a 10% change in isometric elbow strength above baseline, after a single bout of Acute Intermittent Hypoxia (AIH), during screening (described below in detail).

Exclusion Criteria:

  • Diagnosed with any of the following medical conditions: congestive heart failure, cardiac arrhythmias, uncontrolled hypertension, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, emphysema, severe asthma, previous myocardial infraction, or known carotid/intracerebral artery stenosis.
  • Women who are currently pregnant/nursing or planning on becoming pregnant.
  • individuals with a tracheostomy or who utilize mechanical ventilation.
  • Individuals who are currently enrolled in another interventional research study or in therapy. A medical clearance will be required if patients are taking any other investigational agents.
  • Individuals who have an intrathecal baclofen pump or currently taking anti-spasticity medications. These medications include: Baclofen (Lioresal), Clonazepam (Klonopin), Dantrolene (Dantrium), Diazepam (Valium), or Trizanidine (Zanaflex). Subjects will be allowed to participate in the study if they agree to wean off of these medications.
  • Documented obstructive sleep apnea.
  • Orthopedic injuries or surgeries that would impact an individual's ability to use the upper extremity.
  • Traumatic brain injury or other neurological conditions.

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): NCT03433599


Contacts
Contact: Kiara Melendez, BS, MPH 3052439301 kcm26@med.miami.edu
Contact: Francisco Benavides, MD 3055757000 ext 3179 FBenavides@med.miami.edu

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Kiara Melendez, BS, MPH    305-243-9301    kcm26@med.miami.edu   
Contact: Francisco Benavides, MD    3055757000 ext 3179    FBenavides@med.miami.edu   
Principal Investigator: Monica A Perez, PhD         
Sponsors and Collaborators
University of Miami
U.S. Department of Education
Investigators
Principal Investigator: Monica A Perez, PhD Univerisity of Miami

Responsible Party: Monica Perez, Nursing Director, University of Miami
ClinicalTrials.gov Identifier: NCT03433599     History of Changes
Other Study ID Numbers: 20171139
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Monica Perez, University of Miami:
Intermittent Hypoxia
Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Hypoxia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Signs and Symptoms, Respiratory
Signs and Symptoms