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Low Oxygen Therapy for Spinal Cord Injury (BO2ST-II Trial)

N/A
Waitlist Available
Led By Randy Trumbower, PT, PhD
Research Sponsored by Spaulding Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Spinal Cord Injury (SCI) at or below C1 and at or above L2 with at least some sensory or motor function preserved below the neurologic level
Non-progressive etiology of spinal injury
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 14 weeks
Awards & highlights

Summary

This trial aims to see if a combination of low oxygen exposure, spinal cord stimulation, and walking exercises can help improve walking ability in individuals with chronic spinal cord injuries of varying ages.

Who is the study for?
This trial is for people aged 18-80 with chronic spinal cord injury who can walk a little without help. They should have some feeling or movement below the injury and be medically stable. It's not for those with severe pain, illness, heart or lung problems, pregnant women, or anyone using certain other treatments.
What is being tested?
The study tests if low oxygen therapy (acute intermittent hypoxia), transcutaneous spinal cord stimulation (tSTIM), and walking training together can improve walking in people with long-term spinal injuries across different ages.
What are the potential side effects?
Potential side effects may include discomfort from the stimulation device, breathing difficulties due to low oxygen levels during therapy sessions, and general fatigue from physical training.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a spinal cord injury between C1 and L2 but can still feel or move below the injury.
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My spinal injury is not getting worse.
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I am between 18 and 80 years old.
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I can walk 10 meters on my own without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe illness or pain, such as unhealed wounds, extreme nerve pain, serious infections, high blood pressure, heart or lung disease, very weak bones, bone growth in my legs, or intense inflammation.
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My mental function score is below 24.
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I am currently undergoing electrical stimulation therapy.
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I experience severe and frequent sudden high blood pressure due to my spinal cord injury.
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I have severe heart or lung problems, including high blood pressure over 150.
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I have had surgery to move tendons or nerves in my leg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in walking recovery, assessed by 10 meter walk test (10MWT)
Rate of change in walking recovery, assessed by 10 meter walk test (10MWT)
Secondary study objectives
Autonomic dysreflexia incidence rate
Change in bladder dysfunction, assessed by the Neurogenic Bladder Symptom Score (NBSS)
Change in bowel dysfunction, assessed by the Neurogenic Bowel Dysfunction Score (NBDS) v2.1
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM)Experimental Treatment2 Interventions
Acute Intermittent Hypoxia will be used as a pretreatment before walking training paired with transcutaneous spinal cord stimulation.
Group II: Sham + WALKtSTIMPlacebo Group1 Intervention
Sham acute intermittent hypoxia will be used as a pretreatment before walking training paired with transcutaneous spinal cord stimulation.

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor
137 Previous Clinical Trials
10,957 Total Patients Enrolled
United States Department of DefenseFED
891 Previous Clinical Trials
332,418 Total Patients Enrolled
Brooks RehabilitationOTHER
14 Previous Clinical Trials
1,743 Total Patients Enrolled
~40 spots leftby Sep 2027
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