Combination Therapy for Spinal Cord Injury

(BO2ST Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Randy Trumbower, PT, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Spaulding Rehabilitation Hospital

Must not be taking: Botulinum toxin

Disqualifiers: Severe illness, Hypertension, Pregnancy, others

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

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. ^{1 2 3 4 5}

Research Team

Randy Trumbower, PT, PhD

Principal Investigator

Harvard Medical School (HMS and HSDM)

Eligibility Criteria

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.

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.

Trial Timeline

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

Treatment Details

Interventions

• Daily acute intermittent hypoxia (Other)
• Room air (SHAM) (Other)
• Walking + Sham transcutaneous spinal stimulation (tSHAM) (Other)
• Walking + tSTIM (Other)

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.

Participant Groups

Group I: AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM) Experimental Treatment 2 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 Group 2 Interventions

Acute Intermittent Hypoxia will be used as a pretreatment before walking training paired with sham transcutaneous spinal cord stimulation.

Group III: Sham + WALKtSTIM Placebo Group 2 Interventions

Sham acute intermittent hypoxia will be used as a pretreatment before walking training paired with transcutaneous spinal cord stimulation.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Spaulding Rehabilitation Hospital Cambridge, MA

Shirley Ryan AbilityLab Chicago, IL

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Patients Recruited

11,200+

United States Department of Defense

Collaborator

Trials

940

Patients Recruited

339,000+

Shirley Ryan AbilityLab

Collaborator

Trials

212

Patients Recruited

17,900+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Hayes, HB., Jayaraman, A., Herrmann, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive Intermittent Hypoxia and Locomotor Training Enhances Walking Function in Incomplete Spinal Cord Injury Subjects: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial. Navarrete-Opazo, A., Alcayaga, J., Sepúlveda, O., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily acute intermittent hypoxia to improve walking function in persons with subacute spinal cord injury: a randomized clinical trial study protocol. Naidu, A., Peters, DM., Tan, AQ., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged acute intermittent hypoxia improves forelimb reach-to-grasp function in a rat model of chronic cervical spinal cord injury. Arnold, BM., Toosi, BM., Caine, S., et al.[2021]

Therapeutic acute intermittent hypoxia (tAIH) shows promise in improving both respiratory and non-respiratory motor functions in individuals with neuromuscular disorders, particularly those with chronic spinal cord injuries, as highlighted in recent workshops aimed at clinical translation.

Key recommendations for advancing tAIH include enhancing our understanding of its mechanisms, optimizing treatment protocols, identifying effective combinatorial therapies, and ensuring long-term safety, which are essential for its potential routine clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic acute intermittent hypoxia: A translational roadmap for spinal cord injury and neuromuscular disease. Vose, AK., Welch, JF., Nair, J., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Acute intermittent hypoxia as a potential adjuvant to improve walking following spinal cord injury: evidence, challenges, and future directions. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. United States pubmed.ncbi.nlm.nih.gov

Repetitive Intermittent Hypoxia and Locomotor Training Enhances Walking Function in Incomplete Spinal Cord Injury Subjects: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Daily acute intermittent hypoxia to improve walking function in persons with subacute spinal cord injury: a randomized clinical trial study protocol. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Prolonged acute intermittent hypoxia improves forelimb reach-to-grasp function in a rat model of chronic cervical spinal cord injury. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Therapeutic acute intermittent hypoxia: A translational roadmap for spinal cord injury and neuromuscular disease. [2023]