60 Participants Needed

Combination Therapy for Spinal Cord Injury

(BO2ST Trial)

Recruiting at 1 trial location
RT
WM
NP
Arun Jayaraman, PT, PhD profile photo
Overseen ByArun Jayaraman, PT, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Spaulding Rehabilitation Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an active implanted device or are receiving electrical stimulation, you may not be eligible to participate.

Is the combination therapy for spinal cord injury safe for humans?

The combination therapy involving intermittent hypoxia and walking training has been studied in humans with spinal cord injuries, and safety measures such as monitoring pain, spasticity, sleep behavior, cognition, and blood pressure were included in the trials. Repetitive intermittent hypoxia is considered a potentially safe therapeutic alternative for improving walking function in individuals with incomplete spinal cord injuries.12345

How is the treatment for spinal cord injury using daily acute intermittent hypoxia and walking with tSTIM different from other treatments?

This treatment is unique because it combines brief episodes of low-oxygen breathing (acute intermittent hypoxia) with transcutaneous spinal stimulation and walking training to enhance walking recovery in people with spinal cord injuries. This combination aims to promote neuroplasticity (the brain's ability to reorganize itself) and improve walking function more effectively than either treatment alone.24567

What data supports the effectiveness of the treatment Combination Therapy for Spinal Cord Injury?

Research shows that brief episodes of low oxygen breathing, known as acute intermittent hypoxia (AIH), can enhance walking recovery in people with spinal cord injuries by promoting changes in the spinal cord that improve walking speed and endurance. Combining AIH with walking therapy and transcutaneous spinal stimulation (tSTIM) may lead to faster and more lasting improvements in walking ability.24567

Who Is on the Research Team?

RT

Randy Trumbower, PT, PhD

Principal Investigator

Harvard Medical School (HMS and HSDM)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.
My doctor has approved my participation in this study.
See 12 more

Exclusion 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.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a combination of acute intermittent hypoxia, transcutaneous spinal cord stimulation, and walking training to improve walking function

12 weeks
Regular visits for treatment sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Daily acute intermittent hypoxia
  • Room air (SHAM)
  • Walking + Sham transcutaneous spinal stimulation (tSHAM)
  • Walking + tSTIM
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM)Experimental Treatment2 Interventions
Group II: AIH + Walking Training with sham transcutaneous spinal stimulation (WALKtSHAM)Placebo Group2 Interventions
Group III: Sham + WALKtSTIMPlacebo Group2 Interventions

Daily acute intermittent hypoxia is already approved in United States for the following indications:

🇺🇸
Approved in United States as Acute Intermittent Hypoxia for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials
143
Recruited
11,200+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Shirley Ryan AbilityLab

Collaborator

Trials
212
Recruited
17,900+

Published Research Related to This Trial

Daily acute intermittent hypoxia (dAIH) significantly improved walking speed and endurance in individuals with chronic incomplete spinal cord injury, as shown by measurable improvements in the 10-Meter and 6-Minute Walk Tests after just one day of treatment.
Combining dAIH with overground walking further enhanced these benefits, indicating that this combination therapy could be a more effective approach for improving mobility in this population.
Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial.Hayes, HB., Jayaraman, A., Herrmann, M., et al.[2022]
Acute intermittent hypoxia (AIH) is a safe and effective therapy that can enhance strength, walking speed, endurance, and dynamic balance in individuals with chronic, incomplete spinal cord injury (SCI).
AIH shows promise for promoting walking recovery through neuroplasticity mechanisms, but more research is needed to determine its effectiveness across larger groups and to identify optimal treatment protocols.
Acute intermittent hypoxia as a potential adjuvant to improve walking following spinal cord injury: evidence, challenges, and future directions.Tan, AQ., Barth, S., Trumbower, RD.[2022]
A clinical trial is being conducted with 60 participants who have chronic spinal cord injuries to test the combined effects of therapeutic acute intermittent hypoxia (tAIH) and transcutaneous spinal stimulation (WALKtSTIM) on walking recovery, hypothesizing that this combination will lead to faster and more lasting improvements than either treatment alone.
The study will assess various outcomes related to walking ability, endurance, and balance, while also monitoring safety measures such as pain and spasticity, highlighting the need for effective combinatorial treatments for individuals with spinal cord injuries.
A Research Protocol to Study the Priming Effects of Breathing Low Oxygen on Enhancing Training-Related Gains in Walking Function for Persons With Spinal Cord Injury: The BO2ST Trial.Muter, WM., Mansson, L., Tuthill, C., et al.[2023]

Citations

Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. [2022]
Acute intermittent hypoxia as a potential adjuvant to improve walking following spinal cord injury: evidence, challenges, and future directions. [2022]
A Research Protocol to Study the Priming Effects of Breathing Low Oxygen on Enhancing Training-Related Gains in Walking Function for Persons With Spinal Cord Injury: The BO2ST Trial. [2023]
Repetitive Intermittent Hypoxia and Locomotor Training Enhances Walking Function in Incomplete Spinal Cord Injury Subjects: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial. [2022]
Daily acute intermittent hypoxia to improve walking function in persons with subacute spinal cord injury: a randomized clinical trial study protocol. [2020]
Prolonged acute intermittent hypoxia improves forelimb reach-to-grasp function in a rat model of chronic cervical spinal cord injury. [2021]
Therapeutic acute intermittent hypoxia: A translational roadmap for spinal cord injury and neuromuscular disease. [2023]
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