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
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
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?
| Maine | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Spaulding Rehabilitation Hospital | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Cutler MJ, Swift NM, Keller DM, Wasmund WL, Smith ML. Hypoxia-mediated prolonged elevation of sympathetic nerve activity after periods of intermittent hypoxic apnea. J Appl Physiol (1985). 2004 Feb;96(2):754-61. Epub 2003 Oct 10.
- Dale-Nagle EA, Hoffman MS, MacFarlane PM, Mitchell GS. Multiple pathways to long-lasting phrenic motor facilitation. Adv Exp Med Biol. 2010;669:225-30. doi: 10.1007/978-1-4419-5692-7_45.
- Gad P, Hastings S, Zhong H, Seth G, Kandhari S, Edgerton VR. Transcutaneous Spinal Neuromodulation Reorganizes Neural Networks in Patients with Cerebral Palsy. Neurotherapeutics. 2021 Jul;18(3):1953-1962. doi: 10.1007/s13311-021-01087-6. Epub 2021 Jul 9.
- Hayes, H. B., A. Jayaraman, M. Herrmann, G. S. Mitchell, W. Z. Rymer, and R. D. Trumbower. 2013. “Daily Intermittent Hypoxia Enhances Walking After Chronic Spinal Cord Injury: A Randomized Trial”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/01.wnl.0000437416.34298.43.
- Trumbower, Randy D., Arun Jayaraman, Gordon S. Mitchell, and William Z. Rymer. 2011. “Exposure to Acute Intermittent Hypoxia Augments Somatic Motor Function in Humans with Incomplete Spinal Cord Injury”. Neurorehabilitation and Neural Repair. SAGE Publications. doi:10.1177/1545968311412055.
- Tan, Andrew Q., Won Joon Sohn, Avantika Naidu, and Randy D. Trumbower. 2021. “Daily Acute Intermittent Hypoxia Combined with Walking Practice Enhances Walking Performance but Not Intralimb Motor Coordination in Persons with Chronic Incomplete Spinal Cord Injury”. Experimental Neurology. Elsevier BV. doi:10.1016/j.expneurol.2021.113669.
- Estes S, Zarkou A, Hope JM, Suri C, Field-Fote EC. Combined Transcutaneous Spinal Stimulation and Locomotor Training to Improve Walking Function and Reduce Spasticity in Subacute Spinal Cord Injury: A Randomized Study of Clinical Feasibility and Efficacy. J Clin Med. 2021 Mar 11;10(6). pii: 1167. doi: 10.3390/jcm10061167.
- Estes S, Zarkou A, Hope JM, Suri C, Field-Fote EC. Combined Transcutaneous Spinal Stimulation and Locomotor Training to Improve Walking Function and Reduce Spasticity in Subacute Spinal Cord Injury: A Randomized Study of Clinical Feasibility and Efficacy. J Clin Med. 2021 Mar 11;10(6):1167. doi: 10.3390/jcm10061167.
- Cutler MJ, Swift NM, Keller DM, Wasmund WL, Smith ML. Hypoxia-mediated prolonged elevation of sympathetic nerve activity after periods of intermittent hypoxic apnea. J Appl Physiol (1985). 2004 Feb;96(2):754-61. doi: 10.1152/japplphysiol.00506.2003. Epub 2003 Oct 10.
- Randy Trumbower, PT, PhD 2022. "Combination Therapy to Improve SCI Recovery.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05563103.
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