AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM) for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal Cord InjuryDaily acute intermittent hypoxia - Other
Eligibility
18 - 70
All Sexes
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Study Summary

This trial will test if a combination of treatments can improve walking for people with chronic spinal cord injury.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Through study completion, an average of 12 weeks

Week 12
Change in bladder dysfunction, assessed by the Neurogenic Bladder Symptom Score (NBSS)
Intestines
Change in lower extremity strength, assessed by American Spinal Injury Association Impairment Scale (AIS) lower extremity motor scores (LEMS)
Change in pain severity, assessed by the Numeric Pain Rating Scale (NPRS)
Change in physical assistance needed, assessed by Walking Index for Spinal Cord Injury (WISCI) II
Muscle Spasticity
Self-Help Devices
Gait, Unsteady
Gait, Unsteady
Gait, Unsteady
Gait, Unsteady
Week 4
Autonomic Dysreflexia
Change in cognitive function, assessed by the California Verbal Learning Test (CVLT)
Hypertensive disease

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM)
1 of 3
Sham + WALKtSTIM
1 of 3
AIH + Walking Training with sham transcutaneous spinal stimulation (WALKtSHAM)
1 of 3

Experimental Treatment

Non-Treatment Group

60 Total Participants · 3 Treatment Groups

Primary Treatment: AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM) · Has Placebo Group · N/A

AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM)Experimental Group · 2 Interventions: Daily acute intermittent hypoxia, Walking + tSTIM · Intervention Types: Other, Other
Sham + WALKtSTIMShamComparator Group · 2 Interventions: Room air (SHAM), Walking + tSTIM · Intervention Types: Other, Other
AIH + Walking Training with sham transcutaneous spinal stimulation (WALKtSHAM)ShamComparator Group · 2 Interventions: Daily acute intermittent hypoxia, Walking + Sham transcutaneous spinal stimulation (tSHAM) · Intervention Types: Other, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 12 weeks

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor
125 Previous Clinical Trials
10,486 Total Patients Enrolled
United States Department of DefenseFED
777 Previous Clinical Trials
202,437 Total Patients Enrolled
Shirley Ryan AbilityLabOTHER
173 Previous Clinical Trials
13,642 Total Patients Enrolled
Randy Trumbower, PT, PhDPrincipal InvestigatorHarvard Medical School (HMS and HSDM)
2 Previous Clinical Trials
135 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years of age.
You have spinal cord injury at or below C2 (phrenic sparing) and at or above L2 with at least some sensory or motor function preserved below the neurologic level.
You have an ASIA score of C-D at initial screen.
You have a chronic injury (defined as > 12 months post-injury).
You are able to walk a distance of 10 meters without assistance from another person.

Who else is applying?

What state do they live in?
Maine100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Spaulding Rehabilitation Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References