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Behavioural Intervention

dSHAM + Walking + dAIH for Spinal Cord Injury

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
18 to 70 years old
Spinal cord injury (SCI) at or below C3 (phrenic sparing) and above L5 with at least motor function preserved below the neurologic level
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-session 10 (up to two weeks)
Awards & highlights

Study Summary

This trial will help researchers understand if short, controlled episodes of low oxygen can help improve movement and leg strength for people who have recently suffered a spinal cord injury.

Who is the study for?
This trial is for adults aged 18-70 with a spinal cord injury between C3 (but sparing the phrenic nerve) and L5, who still have some motor function. They must be stable medically, 2-12 months post-injury, able to perform certain walking and mobility tests, and not pregnant or suffering from severe illnesses or pain.Check my eligibility
What is being tested?
The study is testing whether mild breathing treatments with low oxygen levels can improve walking ability and leg strength in people who've had a spinal cord injury. Participants will receive daily sessions of either this treatment (dAIH) or a sham procedure (dSHAM).See study design
What are the potential side effects?
Potential side effects may include discomfort due to low oxygen such as headache or shortness of breath during the hypoxia treatment. There's also a risk of increased blood pressure or heart rate changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must be between 18 and 70 years old.
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You have a spinal cord injury above the lower back with some movement still working below the injury.
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Your spinal injury is not getting worse.
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You have a spinal cord injury that is classified as AIS grade A-D.
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You were injured 2 to 12 months ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-session 10 (up to two weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-session 10 (up to two weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in walking recovery, assessed by 10 meter walk test (10MWT)
Change in walking recovery, assessed by 6 minute walk test (6MWT)
Change in walking recovery, assessed by timed up-and-go (TUG) test
Secondary outcome measures
Autonomic dysreflexia incidence rate
Change in pain severity
Change in spasticity
+1 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Non-ambulatory - dAIHExperimental Treatment1 Intervention
Non-ambulatory subjects will be randomly assigned to receive 10 sessions of daily acute intermittent hypoxia (dAIH) 10 treatment visits at a frequency of 5 days each week for 2 weeks.
Group II: Ambulatory-WalkExperimental Treatment1 Intervention
Ambulatory subjects will be randomly assigned to 10 sessions of walking practice only for 5 consecutive sessions/week x 2 weeks.
Group III: Ambulatory - dAIH+WalkExperimental Treatment2 Interventions
Ambulatory subjects will be randomly assigned to receive 10 sessions of daily acute intermittent hypoxia (dAIH) coupled with 60 minutes of walking practice at a frequency of 5 days each week for 2 weeks.
Group IV: Non-ambulatory - dSHAMPlacebo Group1 Intervention
Non-ambulatory subjects will be randomly assigned to receive 10 sessions of daily room air (dSHAM) 10 treatment visits at a frequency of 5 days each week for 2 weeks.
Group V: Ambulatory - dSHAM+WalkPlacebo Group2 Interventions
Ambulatory subjects will be randomly assigned to receive 10 sessions of daily room air (dSHAM) coupled with 60 minutes of walking practice at a frequency of 5 days each week for 2 weeks.

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor
133 Previous Clinical Trials
10,898 Total Patients Enrolled
United States Department of DefenseFED
855 Previous Clinical Trials
225,321 Total Patients Enrolled
Randy Trumbower, PT, PhDPrincipal Investigator - Harvard Medical School (HMS and HSDM)
Spaulding Rehabilitation Hospital
2 Previous Clinical Trials
63 Total Patients Enrolled

Media Library

Daily Acute Intermittent Hypoxia (dAIH) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT02632422 — N/A
Spinal Cord Injury Research Study Groups: Non-ambulatory - dAIH, Non-ambulatory - dSHAM, Ambulatory - dAIH+Walk, Ambulatory - dSHAM+Walk, Ambulatory-Walk
Spinal Cord Injury Clinical Trial 2023: Daily Acute Intermittent Hypoxia (dAIH) Highlights & Side Effects. Trial Name: NCT02632422 — N/A
Daily Acute Intermittent Hypoxia (dAIH) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02632422 — N/A
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT02632422 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Maine
What site did they apply to?
Spaulding Rehabilitation Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I want to walk.
PatientReceived 1 prior treatment
Recent research and studies
~13 spots leftby Mar 2025