Pairing Intermittent Hypoxia and Transcutaneous Electrical Spinal Cord Stimulation to Promote Arm Use After Cervical SCI

Not Applicable

Terminated

Brief Summary: The purpose of this study is to test the efficacy of mild breathing bouts of low oxygen (intermittent hypoxia) combined with transcutaneous electrical spinal cord stimulation on restoring hand function in persons with chronic incomplete spinal cord injury.

Detailed Description: The goal of this study is to determine the effectiveness of repeatedly breathing mild bouts of low oxygen for brief periods (termed acute intermittent hypoxia (AIH)) combined with non-invasive transcutaneous electrical spinal cord stimulation (TESS) on restoring hand function in persons with chronic incomplete SCI.

The fundamental hypothesis guiding this proposal is that daily AIH+TESS engage excitatory and inhibitory pathways, which converge on a common plasticity-promoting cascade that induces greater recovery of hand function than either one alone.

Both treatments appear to enhance motor function in persons with cervical SCI. Despite their independent effects on promoting functional benefits, it is not yet know if they may promote greater functional benefits when combined. To be effective as a long-term rehabilitation strategy, it is essential to determine the efficacy of combined protocols of recurring AIH+TESS.

Recruitment & Eligibility

Inclusion Criteria

18 to 65 years old
medically stable with medical clearance from physician to participate
SCI at or below C3 and at or above C7
non-progressive etiology of spinal injury
American Spinal Injury Association Impairment Scale (AIS) C-D at initial screen
at least 1 year post-injury (chronic)
difficulty independently performing hand functions in activities of daily living

Exclusion Criteria

dependence on ventilation support
implanted stimulator (e.g. diaphragm pacing by phrenic nerve stimulation, vagus nerve stimulator, pacemaker, cochlear implant, epidural stimulator, baclofen pump, etc.)
spinal cord injury related complications including unhealed pressure sore, severe neuropathic or chronic pain syndrome, history of frequent autonomic dysreflexia, infection (e.g. urinary tract), cardiovascular disease (e.g. deep vein thrombosis), pulmonary disease, heterotopic ossification in the upper extremities, severe osteoporosis, unhealed fracture, contracture of the upper extremity joints
received botulinum toxin injections in upper extremity muscles in the prior 6 months
history of tendon or nerve transfer surgery in the upper extremity
history of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.) or peripheral nerve injury in the upper extremity
history of concomitant diseases that would prevent full participation in intensive exercise therapy, such as uncontrolled hypertension, rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.), pulmonary disease, active cancer, chronic contagious disease, etc.
anticoagulation medication
pregnancy
history of allergic reaction or any skin reaction to use of adhesive electrodes

Primary Outcome Measures

Name	Time	Method
Change in Upper Extremity Function	Once each intervention week (days 5, 10, and 15), and once at follow-up (week 8)	Change compared to baseline in upper extremity function performance metrics after treatment assessed using the Graded Redefined Assessment of Strength, Sensation and Prehension test (GRASSP v2). Range: -188 to 188. Higher values represent a better outcome.
Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand	Once each intervention week (days 5, 10, and 15), and once at followup (week 8)	Change in upper extremity strength compared to baseline assessed using dynamometers to measure grip forces.
Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand	Once each intervention week (days 5, 10, and 15), and once at followup (week 8)	Change in upper extremity strength compared to baseline assessed using dynamometers to measure grip forces.

Secondary Outcome Measures

Name	Time	Method

Locations (1): Spaulding Rehabilitation Hospital
🇺🇸
Cambridge, Massachusetts, United States
Spaulding Rehabilitation Hospital
🇺🇸Cambridge, Massachusetts, United States