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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 18 to 70 years of age - medically stable with medical clearance from study physician to participate - SCI at or below C2 (phrenic sparing) and at or above L2 with at least some sensory or motor function preserved below the neurologic level - non-progressive etiology of spinal injury - American Spinal Injury Association (ASIA) scores of C-D at initial screen - ambulatory (able to complete the 10-meter walk test without support from another person) - chronic injury (define as > 12 months post-injury) to avoid potential for spontaneous neurological plasticity and recovery

Exclusion Criteria

  • severe concurrent illness or pain, including unhealed decubiti, severe neuropathic or chronic pain syndrome, severe infection (e.g., urinary tract), hypertension, cardiovascular disease, pulmonary disease, severe osteoporosis, active heterotopic ossification in the lower extremities, severe systemic inflammation - < 24 on Mini-Mental Exam - severe recurrent autonomic dysreflexia - history of severe cardiovascular/pulmonary complications including hypertension (systolic blood pressure > 150 mmHg) - pregnancy because of unknown effects of AIH or tSTIM on a fetus (individuals of childbearing potential will not otherwise be excluded) - botulinum toxin injections in lower extremity muscles within the prior three months - history of tendon or nerve transfer surgery in the lower extremity - untreated severe sleep-disordered breathing characterized by uncontrolled hypoxia and sleep fractionation that may impact the outcome of this study. - active implanted devices (e.g., intrathecal baclofen pump) - receiving concurrent electrical stimulation - motor threshold evoked by transcutaneous spinal stimulation >200 mA

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM) 		Acute Intermittent Hypoxia will be used as a pretreatment before walking training paired with transcutaneous spinal cord stimulation.
  • Other: Daily acute intermittent hypoxia
    Each participant will be exposed to 8 sessions of daily acute intermittent hypoxia via air generators over the span of two weeks. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes which include intervals of 1.5 minute hypoxia (FIO2=0.10±0.02, i.e. 10% O2) and 1 minute normoxia (FIO2=0.21±0.02).
  • Other: Walking + tSTIM
    Individuals will participate in 45 minutes of gait training while having transcutaneous spinal cord stimulation. Stimulation intensity will be 80% involuntary motor threshold.
Sham Comparator
Sham + WALKtSTIM 		Sham acute intermittent hypoxia will be used as a pretreatment before walking training paired with transcutaneous spinal cord stimulation.
  • Other: Room air (SHAM)
    Each participant will be exposed to 8 sessions of daily room air via air generators over the span of two weeks. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes of 1.5 minute normoxia (FIO2=0.21±0.02).
  • Other: Walking + tSTIM
    Individuals will participate in 45 minutes of gait training while having transcutaneous spinal cord stimulation. Stimulation intensity will be 80% involuntary motor threshold.
Sham Comparator
AIH + Walking Training with sham transcutaneous spinal stimulation (WALKtSHAM) 		Acute Intermittent Hypoxia will be used as a pretreatment before walking training paired with sham transcutaneous spinal cord stimulation.
  • Other: Daily acute intermittent hypoxia
    Each participant will be exposed to 8 sessions of daily acute intermittent hypoxia via air generators over the span of two weeks. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes which include intervals of 1.5 minute hypoxia (FIO2=0.10±0.02, i.e. 10% O2) and 1 minute normoxia (FIO2=0.21±0.02).
  • Other: Walking + Sham transcutaneous spinal stimulation (tSHAM)
    Individuals will participate in 45 minutes of gait training while having SHAM transcutaneous spinal cord stimulation. The stimulation will briefly increase to 80% involuntary motor threshold and then brought down to 0 within 30 seconds.

Recruiting Locations

Shirley Ryan AbilityLab
Chicago, Illinois 60611
Contact:
Shreya Aalla, BS
312-238-7323
saalla@sralab.org

Spaulding Rehabilitation Hospital
Cambridge, Massachusetts 02138
Contact:
Noah C Piazza, BS
617-952-6822
npiazza2@mgb.org

More Details

NCT ID
NCT05563103
Status
Recruiting
Sponsor
Spaulding Rehabilitation Hospital

Study Contact

William M. Muter, BS
617-952-6953
wmuter@partners.org

Detailed Description

The goal of the study is to determine whether repeatedly breathing mild bouts of low oxygen for brief periods (termed acute intermittent hypoxia (AIH)) combined with transcutaneous spinal cord stimulation (tSTIM) improves recovery of walking and strength after spinal cord injury. This idea stems from animal studies on respiration, in which investigators showed that mild AIH improves breathing in rats with spinal injuries as well as studies involving spinal cord stimulation. These studies showed that AIH induces plasticity, strengthening neural connections by increasing the production of key proteins and improving the sensitivity of spinal cord circuitry. Additional studies have shown that tSTIM may enhance function and strength for people with spinal cord injuries. The ultimate goal of this research is to assess if combining AIH and tSTIM with walking training can enhance individuals walking training greater than just AIH or tSTIM. By using low oxygen as a pre-treatment to tSTIM during walking training, functional independence and quality of life for servicemen and civilians may improve.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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