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

NCT04854057 | Terminated Results FDA Device

• 1 other identifier: 2020P003328
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

hypoxia; spinal cord injury; rehabilitation; function; low oxygen

Outcome Measures

Primary Outcomes (3)

• Change in Upper Extremity Function

  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.

  Once each intervention week (days 5, 10, and 15), and once at follow-up (week 8)

• Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand

  Change in upper extremity strength compared to baseline assessed using dynamometers to measure grip forces.

  Once each intervention week (days 5, 10, and 15), and once at followup (week 8)

• Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand

  Change in upper extremity strength compared to baseline assessed using dynamometers to measure grip forces.

  Once each intervention week (days 5, 10, and 15), and once at followup (week 8)

Study Arms (2)

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

EXPERIMENTAL

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.

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

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).

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

Interventions

AIH - Intermittent Hypoxia - hypoxia air mixture OTHER

Participants will breathe intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FIO2)=0.10±0.02 (hypoxia). Participants will receive treatment 4 times per week.

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

SHAM - Intermittent Room Air - room air mixture OTHER

Participants will breathe intermittent room air via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FIO2)=0.21±0.02 (normoxia). Participants will receive treatment 4 times per week.

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

TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task Practice DEVICE

Participants will receive transcutaneous electrical stimulation to the cervical spinal cord using the TESCoN device developed by SpineX, Inc. Training will consist of progressive functional task practice for upper extremity motor training. A total of 24 treatment sessions, which will last 45 minutes per session, will be completed in 3 weeks (4 days/week) per crossover arm.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (4)

• Trumbower RD, Hayes HB, Mitchell GS, Wolf SL, Stahl VA. Effects of acute intermittent hypoxia on hand use after spinal cord trauma: A preliminary study. Neurology. 2017 Oct 31;89(18):1904-1907. doi: 10.1212/WNL.0000000000004596. Epub 2017 Sep 29.

  PMID: 28972191 BACKGROUND

• Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.

  PMID: 29877852 BACKGROUND

• Hoffman L, Field-Fote E. Effects of practice combined with somatosensory or motor stimulation on hand function in persons with spinal cord injury. Top Spinal Cord Inj Rehabil. 2013 Fall;19(4):288-99. doi: 10.1310/sci1904-288.

  PMID: 24244094 BACKGROUND

• Gad P, Lee S, Terrafranca N, Zhong H, Turner A, Gerasimenko Y, Edgerton VR. Non-Invasive Activation of Cervical Spinal Networks after Severe Paralysis. J Neurotrauma. 2018 Sep 15;35(18):2145-2158. doi: 10.1089/neu.2017.5461.

  PMID: 29649928 BACKGROUND

Related Links

• INSPIRE Lab - dedicated to inspire persons with paralysis to move again

MeSH Terms

Conditions

Spinal Cord Injuries; Hypoxia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Randy Trumbower
• Organization: Spaulding Rehabilitation

randy.trumbower@mgh.harvard.edu

6179526822

Study Officials

• Randy Trumbower, PT, PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 22, 2021
• Study Start: March 3, 2021
• Primary Completion: October 22, 2021
• Study Completion: October 22, 2021
• Last Updated: January 10, 2024
• Results First Posted: January 10, 2024

Record last verified: 2024-01

Locations

US (1)