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Trial record 54 of 56 for:    stem cell Spinal Cord Injury AND cells

Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High Intensity Training on Upper Limb Function in Individuals With Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03643770
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Zev Rymer, Shirley Ryan AbilityLab

Tracking Information
First Submitted Date  ICMJE March 12, 2018
First Posted Date  ICMJE August 23, 2018
Last Update Posted Date November 29, 2018
Actual Study Start Date  ICMJE November 16, 2018
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
GRASSP [ Time Frame: 4 weeks ]
Graded Redefined Assessment of Strength, Sensation and Prehension
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03643770 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
  • 9-hole peg test [ Time Frame: 4 weeks ]
    coordination
  • grip strength [ Time Frame: 4 weeks ]
    hand strength
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High Intensity Training on Upper Limb Function in Individuals With Spinal Cord Injury
Official Title  ICMJE Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High Intensity Training on Upper Limb Function in Individuals With Spinal Cord Injury
Brief Summary

Currently, there are a variety of approaches utilized in attempts to improve upper extremity function, including: traditional therapy, neuroprostheses, botulinum toxin injections, or surgical interventions. In addition, regenerative and restorative therapies, such as: epidural stimulation, functional electrical stimulation, and stem cell therapies, show promise in animal models, but are not ready for clinical translation. Subsequently, there is a clear need to develop new strategies that can stimulate spinal plasticity and strengthen existing synaptic connections in order to maximize the benefits of training paradigms.

This study proposes the examine the effects of Acute Intermittent Hypoxia (AIH) in combination with upper extremity training, over the course of a month, to evaluate changes in upper extremity function, dexterity, and ability to complete activities of daily living. The use of acute intermittent hypoxia (AIH) has been demonstrated, through human and animal studies, to be an effective way of increasing spinal motor excitability and strengthening residual synaptic connectivity. AIH utilizes short duration (<2 min) exposures to reduced oxygen levels (~10% inspired oxygen), with alternating exposures to air with normal oxygen levels (~21% inspired oxygen).

Previous publications demonstrate that AIH is a safe and effective intervention to modify motor function in individual with chronic incomplete spinal cord injuries. The use of AIH has been shown to influence the activation in musculature, within 60-120 minutes of administration. In addition, when coupling AIH with overground gait training, an increase in functional endurance, as evaluated through the 6 minute walk test, and gait speed, as evaluated through the 10 meter walk test, were demonstrated. In addition, the use of hypoxic training has been studied in healthy individuals and athletes; however, literature examining the effect of a single bout of AIH on performance is limited.

Detailed Description

This study proposes the examine the effects of Acute Intermittent Hypoxia (AIH) in combination with upper extremity training, over the course of a month, to evaluate changes in upper extremity function, dexterity, and ability to complete activities of daily living. The use of acute intermittent hypoxia (AIH) has been demonstrated, through human and animal studies, to be an effective way of increasing spinal motor excitability and strengthening residual synaptic connectivity. AIH utilizes short duration (<2 min) exposures to reduced oxygen levels (~10% inspired oxygen), with alternating exposures to air with normal oxygen levels (~21% inspired oxygen).

Previous publications demonstrate that AIH is a safe and effective intervention to modify motor function in individual with chronic incomplete spinal cord injuries. The use of AIH has been shown to influence the activation in musculature, within 60-120 minutes of administration. In addition, when coupling AIH with overground gait training, an increase in functional endurance, as evaluated through the 6 minute walk test, and gait speed, as evaluated through the 10 meter walk test, were demonstrated. In addition, the use of hypoxic training has been studied in healthy individuals and athletes; however, literature examining the effect of a single bout of AIH on performance is limited.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
4 randomized groups: Acute Intermittent Hypoxia (AIH) treatment, AIH in combination with upper extremity training, Sham AIH therapy in combination with upper extremity training and Sham AIH therapy
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE Combination Product: Upper extremity training/Armeo Spring
Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs.
Study Arms  ICMJE
  • No Intervention: Acute Intermittent Hypoxia (AIH) treatment
    The mask will first provide a normoxic air (room air) mixture (FiO2 = 0.21) via the mask. The mask is designed to couple with a universal mask circuit connecting to the air mixture system. The purpose of the mask will be to minimize room air entrainment.
  • Active Comparator: AIH in combination with upper extremity training
    The mask will first provide a normoxic air (room air) mixture (FiO2 = 0.21) via the mask. The mask is designed to couple with a universal mask circuit connecting to the air mixture system. The purpose of the mask will be to minimize room air entrainment. In addition to this upper extremity training will be given using an upper-limb robotic rehabilitation device.
    Intervention: Combination Product: Upper extremity training/Armeo Spring
  • Active Comparator: Sham AIH therapy in combination with upper extremity training
    Sham hypoxia followed by upper extremity training will be given using an upper-limb robotic rehabilitation device (Armeo Spring®, Hocoma AG, Switzerland). Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs.
    Intervention: Combination Product: Upper extremity training/Armeo Spring
  • No Intervention: Sham AIH therapy
    Sham hypoxia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 21, 2018)
92
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • History of a non-progressive spinal cord injury, inclusive of levels of C3-T1.
  • Etiology of spinal cord injury is non-progressive in nature
  • Be able to demonstrate some hand muscle activation,
  • At least 1 year post injury
  • Ability to open and close at least one hand without assistance
  • At least a 10% increase in isometric elbow flexion force above baseline, after a single bout of Acute Intermittent Hypoxia (AIH), during first screening visit
  • Participants do NOT have to stop taking antispasticity medications to participate in the study.
  • Must be tested for anemia with a value of at least 10g/dl (for both men and women).
  • Patients will be recommended to their primary care physician to correct anemia if low levels are detected
  • Blood pressure must fall within this range- high: 160/110mmHg low: 85/55 mmHg
  • Must be asymptomatic (no dizziness, lightheadedness, etc)

Exclusion Criteria:

  • Medical conditions, including: 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 or planning on becoming pregnant
  • Current tracheostomy placement
  • Utilization of mechanical ventilator for breathing
  • Current diagnosis of obstructive sleep apnea
  • Orthopedic injuries or surgeries that would limit participation
  • Concurrent participation in another research study or therapy services
  • Comorbid traumatic brain injury or other neurologic injuries that would impact cognition
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sneha Solanki, MSc 312-238-3647 ssolanki02@sralab.org
Contact: Zev Rymer, MD zrymer@sralab.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03643770
Other Study ID Numbers  ICMJE STU 00206035
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zev Rymer, Shirley Ryan AbilityLab
Study Sponsor  ICMJE Shirley Ryan AbilityLab
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shirley Ryan AbilityLab
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP