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

Mass General Brigham

Status: Terminated

Conditions: Spinal Cord Injuries

Treatments: Other: AIH - Intermittent Hypoxia - hypoxia air mixture; Other: SHAM - Intermittent Room Air - room air mixture; Device: TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task Practice

Study type: Interventional

Funder types: Other

Identifiers

NCT04854057

2020P003328

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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3 participants in 2 patient groups

Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First

Experimental group

Description:

Round 1 1st Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 1 2nd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Round 1 3rd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Washout (1 month) Round 2 1st Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 2 2nd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM. Round 2 3rd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH.

Treatment:

Other: AIH - Intermittent Hypoxia - hypoxia air mixture

Other: SHAM - Intermittent Room Air - room air mixture

Device: TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task Practice

Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First

Experimental group

Description:

Round 1 1st Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 1 2nd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM. Round 1 3rd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH. Washout (1 month) Round 2 1st Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 2 2nd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Round 2 3rd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).

Treatment:

Other: AIH - Intermittent Hypoxia - hypoxia air mixture

Other: SHAM - Intermittent Room Air - room air mixture

Device: TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task Practice