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Combination Therapy for Spinal Cord Injury (BO2ST Trial)
N/A
Recruiting
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
18 to 70 years of age
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
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 12 weeks
Summary
This trial will test if a combination of treatments can improve walking for people with chronic spinal cord injury.
Who is the study for?
This trial is for adults aged 18-70 with chronic spinal cord injury (SCI) that's non-progressive and occurred over a year ago. Participants must be able to walk 10 meters without help, have some preserved sensory or motor function below the injury level, and score C-D on the ASIA scale. Pregnant individuals, those with active implants like baclofen pumps, recent botulinum toxin injections in legs, severe concurrent illnesses or certain surgeries are excluded.
What is being tested?
The study tests if combining low oxygen levels (acute intermittent hypoxia), transcutaneous spinal stimulation (tSTIM), and walking training can improve walking in people with chronic SCI. It compares this combination therapy against sham interventions plus walking to see which is more effective.
What are the potential side effects?
Potential side effects may include discomfort from the stimulation device, breathing difficulties due to low oxygen sessions, muscle fatigue from walking exercises, and possible skin irritation at the stimulation site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
Select...
My spinal cord injury is between my neck and upper back, but I can still feel or move parts of my body below the injury.
Select...
My spinal injury is not getting worse.
Select...
I have some feeling or movement below my spinal cord injury.
Select...
My spinal injury is not getting worse.
Select...
I can walk 10 meters on my own without help.
Select...
I am between 18 and 70 years old.
Select...
My spinal cord injury is between my neck and upper back, but I can still feel or move parts of my body below the injury.
Select...
My spinal injury is not getting worse.
Select...
I can walk 10 meters without help.
Select...
My injury occurred over a year ago, minimizing chances of natural recovery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe illness or pain that would interfere with the study.
Select...
My mental function test score is below 24.
Select...
I experience severe and repeated episodes of autonomic dysreflexia.
Select...
I have had serious heart or lung problems, including high blood pressure over 150.
Select...
I have had botulinum toxin injections in my leg muscles in the last 6 months.
Select...
I have had surgery to move tendons or nerves in my leg.
Select...
I am currently undergoing electrical stimulation therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Gait, Unsteady
Gait, Unsteady
Secondary study objectives
Autonomic Dysreflexia
Change in cognitive function, assessed by the California Verbal Learning Test (CVLT)
Change in pain severity, assessed by the Numeric Pain Rating Scale (NPRS)
+3 moreOther study objectives
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
Change in lower extremity strength, assessed by American Spinal Injury Association Impairment Scale (AIS) lower extremity motor scores (LEMS)
+3 moreTrial Design
3Treatment 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: AIH + Walking Training with sham transcutaneous spinal stimulation (WALKtSHAM)Placebo Group2 Interventions
Acute Intermittent Hypoxia will be used as a pretreatment before walking training paired with sham transcutaneous spinal cord stimulation.
Group III: Sham + WALKtSTIMPlacebo Group2 Interventions
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
139 Previous Clinical Trials
11,028 Total Patients Enrolled
United States Department of DefenseFED
917 Previous Clinical Trials
334,639 Total Patients Enrolled
Shirley Ryan AbilityLabOTHER
208 Previous Clinical Trials
17,865 Total Patients Enrolled
Randy Trumbower, PT, PhDPrincipal InvestigatorHarvard Medical School (HMS and HSDM)
3 Previous Clinical Trials
188 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience severe and repeated episodes of autonomic dysreflexia.I do not have severe illness or pain that would interfere with the study.I have had serious heart or lung problems, including high blood pressure over 150.I have severe sleep problems that haven't been treated.I can walk 10 meters on my own without help.You have experienced a brain or spinal cord injury more than a year ago, so that any natural recovery has already occurred.I have had botulinum toxin injections in my leg muscles in the last 6 months.I have had surgery to move tendons or nerves in my leg.My doctor has approved my participation in this study.You have an ASIA score of C-D at initial screen.My mental function test score is below 24.I am currently undergoing electrical stimulation therapy.You have a severe spinal cord injury with a specific level of impairment.My spinal injury is not getting worse.I am between 18 and 70 years old.My spinal injury is not getting worse.I am between 18 and 70 years old.I have some feeling or movement below my spinal cord injury.My spinal cord injury is between my neck and upper back, but I can still feel or move parts of my body below the injury.My doctor has approved my participation in this study.I can walk 10 meters without help.My spinal injury is not getting worse.My injury occurred over a year ago, minimizing chances of natural recovery.You have had a brain or nerve injury for more than a year to avoid the possibility of unexpected healing.My spinal cord injury is between my neck and upper back, but I can still feel or move parts of my body below the injury.
Research Study Groups:
This trial has the following groups:- Group 1: AIH + Walking Training with sham transcutaneous spinal stimulation (WALKtSHAM)
- Group 2: AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM)
- Group 3: Sham + WALKtSTIM
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT05563103 — N/A