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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 12 weeks
Awards & highlights
BO2ST Trial 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.Check my eligibility
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.See study design
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.
BO2ST Trial 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.
BO2ST Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Gait, Unsteady
Gait, Unsteady
Secondary outcome measures
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 outcome measures
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 moreBO2ST Trial 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
135 Previous Clinical Trials
10,995 Total Patients Enrolled
United States Department of DefenseFED
863 Previous Clinical Trials
227,572 Total Patients Enrolled
Shirley Ryan AbilityLabOTHER
193 Previous Clinical Trials
16,825 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible to contribute data for this clinical research?
"This clinical trial is seeking 60 applicants with spinal cord injuries, who are aged between 18 and 70. In addition to this criterion, they must be medically stable as judged by the study physician, have an SCI at or below C2 (with phrenic nerve sparing) and above L2 with preserved motor/sensory function beneath the neurological level; their injury cannot be of a progressive etiology, ASIA scores must range from C-D at initial screening appointments and it needs to have been chronic for more than 12 months in order to rule out any chance of spontaneous plasticity recovery; lastly patients need to demonstrate ambulatory"
Answered by AI
Is eligibility for this research study limited to adults only?
"Based on the criteria stipulated, this clinical trial is open to individuals between 18 and 70 years of age. Additionally, there are 37 studies dedicated solely for those under 18 while 308 separate trials focus exclusively on elderly participants over 65."
Answered by AI
What is the ultimate goal of this research endeavor?
"This clinical trial, which is set to be completed over 12 weeks, will assess recovery in walking ability through the 10 Meter Walk Test (10MWT). Secondary outcomes include change observed in 6 Minute Walk Test performance (6MWT), systemic hypertension incidence rate and cognitive function shifts measured by California Verbal Learning Tests (CVLT)."
Answered by AI
Are new participants being accepted into this research endeavor?
"According to information posted on clinicaltrials.gov, this medical trial is not actively seeking participants at the current moment. The study was first launched October 1st 2022 and last modified September 28th of that same year. Nevertheless, 354 other studies are now recruiting patients for their respective trials."
Answered by AI
Who else is applying?
What state do they live in?
California
Maine
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Spaulding Rehabilitation Hospital
Shirley Ryan AbilityLab
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
0
Why did patients apply to this trial?
I just really wabt to walk. I am always interested in improving my motor function and working to get better. This seems like a great chance to provide myself that opportunity.
PatientReceived 2+ prior treatments
I have been slowly recovering mobility but am not able to walk independently. I want to regain my independence and the ability to walk again. I have researched the e-stim trials and want to give it a go, I believe it can help me!
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Where am I be staying? How long does screening take? How long do visits take? Would lodging be my responsibility? Would I need to stay in the area for the duration of the trial?
PatientReceived no prior treatments
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