Health TrialsbyHealthPanel

Combination Therapy to Improve SCI Recovery.

ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSpaulding Rehabilitation Hospital

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Daily acute intermittent hypoxia

    Other intervention

    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).

  • Room air (SHAM)

    Other intervention

    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).

  • Walking + tSTIM

    Other intervention

    Individuals will participate in 45 minutes of gait training while having transcutaneous spinal cord stimulation. Stimulation intensity will be 80% involuntary motor threshold.

  • Walking + Sham transcutaneous spinal stimulation (tSHAM)

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM)Experimental treatment 2 interventions
Group B: Sham + WALKtSTIMSham comparator 2 interventions
Group C: AIH + Walking Training with sham transcutaneous spinal stimulation (WALKtSHAM)Sham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in walking recovery, assessed by 10 meter walk test (10MWT)

Participants walk ten meters without assistance at their fastest, but safest speed with a minimum of 1-minute of rest between two trials. Average speed across the up to three 10MWT trials will be used for analysis. Change is the difference between the post-treatment assessment 2 and pre-treatment baseline.

Time frame
Through study completion, an average of 12 weeks
2

Rate of change in walking recovery, assessed by 10 meter walk test (10MWT)

Participants walk ten meters without assistance at their fastest, but safest speed with a minimum of 1-minute of rest between two trials. Average speed across the up to three 10MWT trials will be used for analysis. Rate of change is the number of treatment sessions required to achieve an increase in 10MWT speed of at least the minimal clinically important difference (0.06 m/s) as compared to pre-treatment baseline.

Time frame
Through study completion, an average of 12 weeks

Secondary outcomes

1

Change in walking recovery, assessed by 6 minute walk test (6MWT)

Participants perform the 6MWT at their fastest, most comfortable walking speed sustainable for 6 minutes. Distances will be recorded at 2 and 6 minutes. The test will be based upon the participant's ability to finish each assessment without human assistance. Change is the difference between the post-treatment assessment 2 and pre-treatment baseline.

Time frame
Through study completion, an average of 12 weeks
2

Change in walking recovery, assessed by timed up-and-go (TUG) test

The TUG test is used to assess the dynamic balance of an individual. It measures the amount of time (recorded in seconds) it takes for the individual to rise from a standard arm chair, walk a distance of 3 meters and return to the initial position resting against the back of the chair. Participants will perform up to three trials of the TUG test. Average speed across TUG trials will be used for analysis. Change is the difference between the post-treatment assessment 2 and pre-treatment baseline.

Time frame
Through study completion, an average of 12 weeks
3

Change in pain severity, assessed by the Numeric Pain Rating Scale (NPRS)

Participants will report their pain level using the Numeric Pain Rating Scale. The scale is from 0 to 10; 0 being no pain and 10 being extreme pain. Change is the difference between the post-treatment assessment 2 and pre-treatment baseline.

Time frame
Through study completion, an average of 12 weeks
4

Change in cognitive function, assessed by the California Verbal Learning Test (CVLT)

The CVLT is a brief, individually administered battery to measure cognitive decline or improvement and assesses verbal learning and memory for older adolescents and adults. Change is the difference between the post-treatment assessment 2 and pre-treatment baseline.

Time frame
Through treatment completion, an average of 4 weeks

Other outcomes

1

Change in lower extremity strength, assessed by American Spinal Injury Association Impairment Scale (AIS) lower extremity motor scores (LEMS)

The LEMS uses ASIA key muscles in both the lower extremities, with a total possible score of 50 (maximum score of 5 for each muscle group). Change is the difference between the post-treatment assessment 2 and pre-treatment baseline.

Time frame
Through study completion, an average of 12 weeks
2

Change in spasticity, assessed by the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS)

The study team will quantify the total lower extremity spasticity score using the cumulative sum of 3 SCATS subscales: clonus (0=no spasticity; 3=severe), flexor (0=no spasticity; 3=severe), and extensor (0=no spasticity; 3=severe). Change is the difference between the post-treatment assessment 2 and pre-treatment baseline.

Time frame
Through study completion, an average of 12 weeks
3

Change in bowel dysfunction, assessed by the Neurogenic Bowel Dysfunction Score (NBDS) v2.1

This questionnaire is a symptom-based score for neurogenic bowel dysfunction. Change is the difference between the post-treatment assessment 2 and pre-treatment baseline.

Time frame
Through study completion, an average of 12 weeks
4

Change in bladder dysfunction, assessed by the Neurogenic Bladder Symptom Score (NBSS)

This questionnaire is a symptom-based score for neurogenic bladder dysfunction. Change is the difference between the post-treatment assessment 2 and pre-treatment baseline.

Time frame
Through study completion, an average of 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spaulding Rehabilitation Hospital

Lead sponsor

United States Department of Defense

Collaborator

Shirley Ryan AbilityLab

Collaborator

Source ClinicalTrials.gov
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