Combination Therapy to Improve SCI Recovery.

Description

The purpose of this study is to determine how combining bouts of low oxygen, transcutaneous spinal cord stimulation, and walking training may improve walking function for people with chronic spinal cord injury.

Conditions

Spinal Cord Injuries

Study Overview

Study Details

Study overview

The purpose of this study is to determine how combining bouts of low oxygen, transcutaneous spinal cord stimulation, and walking training may improve walking function for people with chronic spinal cord injury.

Breathing Low Oxygen to Enhance Spinal Stimulation Training and Functional Recovery in Persons With Chronic SCI: The BO2ST Trial

Combination Therapy to Improve SCI Recovery.

Condition
Spinal Cord Injuries
Intervention / Treatment

-

Contacts and Locations

Chicago

Shirley Ryan AbilityLab, Chicago, Illinois, United States, 60611

Cambridge

Spaulding Rehabilitation Hospital, Cambridge, Massachusetts, United States, 02138

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18 to 70 years of age
  • * medically stable with medical clearance from study physician to participate
  • * SCI at or below C2 (phrenic sparing) and at or above L2 with at least some sensory or motor function preserved below the neurologic level
  • * non-progressive etiology of spinal injury
  • * American Spinal Injury Association (ASIA) scores of C-D at initial screen
  • * ambulatory (able to complete the 10-meter walk test without support from another person)
  • * chronic injury (define as \> 12 months post-injury) to avoid potential for spontaneous neurological plasticity and recovery
  • * severe concurrent illness or pain, including unhealed decubiti, severe neuropathic or chronic pain syndrome, severe infection (e.g., urinary tract), hypertension, cardiovascular disease, pulmonary disease, severe osteoporosis, active heterotopic ossification in the lower extremities, severe systemic inflammation
  • * \< 24 on Mini-Mental Exam
  • * severe recurrent autonomic dysreflexia
  • * history of severe cardiovascular/pulmonary complications including hypertension (systolic blood pressure \> 150 mmHg)
  • * pregnancy because of unknown effects of AIH or tSTIM on a fetus (individuals of childbearing potential will not otherwise be excluded)
  • * botulinum toxin injections in lower extremity muscles within the prior three months
  • * history of tendon or nerve transfer surgery in the lower extremity
  • * untreated severe sleep-disordered breathing characterized by uncontrolled hypoxia and sleep fractionation that may impact the outcome of this study.
  • * active implanted devices (e.g., intrathecal baclofen pump)
  • * receiving concurrent electrical stimulation
  • * motor threshold evoked by transcutaneous spinal stimulation \>200 mA

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Spaulding Rehabilitation Hospital,

Randy Trumbower, PT, PhD, PRINCIPAL_INVESTIGATOR, Harvard Medical School (HMS and HSDM)

Study Record Dates

2026-12