RECRUITING

AIH for Spinal Cord Repair

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Contusive cervical spinal cord injury (cSCI) impairs upper limb function (reach-and-grasp) which limits daily-life activities and thus decreases the quality of life. Promoting neuroplasticity may support upper limb recovery after SCI. Repetitive exposure to acute intermittent hypoxia (rAIH) combined with motor training promotes recovery of motor function after SCI; however, the overall effects of rAIH/training are limited. The investigators will use an adult rat model of long-term contusive cSCI to study novel approaches to enhance the effect of rAIH/training on forelimb function and study the neuronal substrate underlying the effects. The findings will be used to direct the development of more effective rAIH/training approaches for people with contusive, functionally incomplete, cSCI. Because deficits in upper limb function are a major problem after stroke, amyotrophic lateral sclerosis, multiple sclerosis, and other motor disorders, this work may also be relevant for patients with other types of central nervous system (CNS) lesions.

Official Title

Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair

Quick Facts

Study Start:2020-02-25
Study Completion:2025-02-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03780829

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.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and females Veterans between 18-85 years
  2. * Chronic cSCI (1 yr of injury)
  3. * Cervical injury at C8 or above
  4. * Sensory function: impaired (score of 1) but not absent (score of 0) or intact (score of 2) innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) sensory scores
  5. * Motor function: Able to grasp small objects with one hand and able to perform a visible precision grasp between the index finger and thumb
  6. * Motor scores ISNCSCI: 1 to 4 but not 5 on finger flexors and finger abductors on the hand tested.
  7. * These criteria were selected to ensure that hand impairment will not interfere with the ability to perform training and proposed tests
  8. * Male and females (18-80 years)
  9. * Right handed
  10. * Able to complete precision and power grips
  1. * Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
  2. * Any debilitating disease prior to the SCI that caused exercise intolerance
  3. * Premorbid, ongoing major depression or psychosis, altered cognitive status
  4. * History of head injury or stroke
  5. * Metal plate in skull
  6. * History of seizures
  7. * Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs
  8. * chlorpromazine
  9. * clozapine
  10. * or tricyclic antidepressants
  11. * Pregnant females
  12. * Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease as spinal stenosis, spina bifida or herniated cervical disk
  13. * AIH Exclusion Criteria (in addition to the above listed exclusion criteria):
  14. * resting heart rate \> 120 bpm
  15. * resting systolic blood pressure \>180 mmHg
  16. * resting diastolic blood pressure \>100 mmHg
  17. * self-reported history of unstable angina or myocardial infarction within the previous month
  18. * resting SpO2 \> or equal to 95%
  19. * cardiopulmonary complications such as COPD
  20. * Same as for SCI individuals

Contacts and Locations

Study Contact

Martin Oudega, PhD
CONTACT
(305) 575-7000
moudega@sralab.org
Monica A Perez, PhD
CONTACT
(312) 238-2886
mperez04@sralab.org

Principal Investigator

Martin Oudega, PhD
PRINCIPAL_INVESTIGATOR
Edward Hines Jr. VA Hospital, Hines, IL

Study Locations (Sites)

Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Martin Oudega, PhD, PRINCIPAL_INVESTIGATOR, Edward Hines Jr. VA Hospital, Hines, IL

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 Registration Dates

Study Start Date2020-02-25
Study Completion Date2025-02-10

Study Record Updates

Study Start Date2020-02-25
Study Completion Date2025-02-10

Terms related to this study

Keywords Provided by Researchers

  • spinal cord injury
  • hypoxia
  • plasticity

Additional Relevant MeSH Terms

  • SCI