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

Primary Purpose

Spinal Cord Injuries

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

AIH - Intermittent Hypoxia - hypoxia air mixture

SHAM - Intermittent Room Air - room air mixture

TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task Practice

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring hypoxia, spinal cord injury, rehabilitation, function, low oxygen

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

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

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

Arm Description

Intervention: AIH - Intermittent Hypoxia - hypoxia air mixture Dosage: 10% oxygen Frequency: 1.5 minutes bouts of low oxygen with 1.0 minute intervals of room air Duration: 38 minutes TESS + Functional Task Practice Duration: 45 minutes

Intervention: SHAM - Intermittent Room Air - room air mixture Dosage: 21% oxygen Frequency: 1.5 minutes bouts of room air with 1.0 minute intervals also of room air Duration: 38 minutes TESS + Functional Task Practice Duration: 45 minutes

Outcomes

Primary Outcome Measures

Change in upper extremity function

Change in upper extremity function performance metrics after treatment assessed using the Graded Redefined Assessment of Strength, Sensation and Prehension test (GRASSP).

Change in upper extremity strength

Change in upper extremity strength after treatment assessed using dynamometers to measure pinch and grip forces.

Secondary Outcome Measures

Superiority of combined AIH + TESS Therapy vs. TESS alone to improve upper extremity function

Superiority as demonstrated by statistically significant difference in the improvement of subjects' upper extremity function between the AIH and SHAM treatment arms assessed using the Graded Redefined Assessment of Strength, Sensation and Prehension test (GRASSP).

Superiority of combined AIH + TESS Therapy vs. TESS alone to improve upper extremity strength

Superiority as demonstrated by statistically significant difference in the improvement of subjects' upper extremity strength between the AIH and SHAM treatment arms assessed using dynamometers to measure pinch and grip forces.

Full Information

NCT ID

NCT04854057

First Posted

April 14, 2021

Last Updated

April 13, 2023

Sponsor

Spaulding Rehabilitation Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04854057

Brief Title

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

Official Title

Combinatorial Treatment of Acute Intermittent Hypoxia and Transcutaneous Electrical Spinal Cord Stimulation to Improve Hand Function in People With Cervical Spinal Cord Injury

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Terminated

Why Stopped

No funding or personnel for project. We are unable to meet the recruitment goals for this clinical study.

Study Start Date

March 3, 2021 (Actual)

Primary Completion Date

October 22, 2021 (Actual)

Study Completion Date

October 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Spaulding Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Description

Arm Title

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

Arm Type

Sham Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

AIH - Intermittent Hypoxia - hypoxia air mixture

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

SHAM - Intermittent Room Air - room air mixture

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task Practice

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in upper extremity function

Description

Change in upper extremity function performance metrics after treatment assessed using the Graded Redefined Assessment of Strength, Sensation and Prehension test (GRASSP).

Time Frame

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

Title

Change in upper extremity strength

Description

Change in upper extremity strength after treatment assessed using dynamometers to measure pinch and grip forces.

Time Frame

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

Secondary Outcome Measure Information:

Title

Superiority of combined AIH + TESS Therapy vs. TESS alone to improve upper extremity function

Description

Time Frame

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

Title

Superiority of combined AIH + TESS Therapy vs. TESS alone to improve upper extremity strength

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Randy Trumbower, PT, PhD

Organizational Affiliation

Harvard Medical School (HMS and HSDM)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Spaulding Rehabilitation Hospital

City

Cambridge

State/Province

Massachusetts

ZIP/Postal Code

02138

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28972191

Citation

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.

Results Reference

background

PubMed Identifier

29877852

Citation

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.

Results Reference

background

PubMed Identifier

24244094

Citation

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.

Results Reference

background

PubMed Identifier

29649928

Citation

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.

Results Reference

background

Links:

URL

https://www.inspire-lab.org/

Description

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

Learn more about this trial

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

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