RECRUITING

Combination Therapy to Improve SCI Recovery.

Conditions

Spinal Cord Injuries Walk Rehabilitation Strength Movement Spinal cord injury low oxygen electrical stimulation walking training

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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

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.

Official Title

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

Quick Facts

Study Start:2023-01-17

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05563103

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 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

William M. Muter, BS

CONTACT

617-952-6953

wmuter@partners.org

Randy Trumbower, PT, PhD

CONTACT

randy.trumbower@mgh.harvard.edu

Principal Investigator

Randy Trumbower, PT, PhD

PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Study Locations (Sites)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611

United States

Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, 02138

United States

Collaborators and Investigators

Sponsor: Spaulding Rehabilitation Hospital

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

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 Date2023-01-17

Study Completion Date2026-12

Study Record Updates

Study Start Date2023-01-17

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Walk
Rehabilitation
Strength
Movement
Spinal cord injury
low oxygen
electrical stimulation
walking training

Additional Relevant MeSH Terms

Spinal Cord Injuries