Spinal Cord InjuriesNCT04854057

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

A study testing AIH - Intermittent Hypoxia - hypoxia air mixture and TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task Practice in people with Spinal Cord Injuries, run by Spaulding Rehabilitation Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Spinal Cord Injuries
What is being tested?: AIH - Intermittent Hypoxia - hypoxia air mixture and TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task Practice
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3 participants
Where: 1 siteUnited States
Study dates: 3 Mar 2021to 22 Oct 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, 02138

Other trials in United States

About this study

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

Read the 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.

Conditions: Spinal Cord Injuries
Being tested: AIH - Intermittent Hypoxia - hypoxia air mixture, SHAM - Intermittent Room Air - room air mixture, TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task Practice
Keywords: hypoxia, spinal cord injury, rehabilitation, function, low oxygen
Medical subject headings: Spinal Cord Injuries, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AIH - Intermittent Hypoxia - hypoxia air mixtureOther
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.
SHAM - Intermittent Room Air - room air mixtureOther
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.
TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task PracticeDevice
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.

Study groups in NCT04854057
Study group	Role	What they receive
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. Receives: 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). Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 202122 Oct 2021

First posted22 Apr 2021
Study start3 Mar 2021
Primary completion22 Oct 2021
Study completion22 Oct 2021

Why it stopped: No funding or personnel for project. We are unable to meet the recruitment goals for this pilot study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04854057
Sponsor's protocol ID: 2020P003328
Status last verified: Jan 2024
First submitted: 14 Apr 2021
Last updated: 10 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

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.
PubMed 28972191
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.
PubMed 29877852
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.
PubMed 24244094
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.
PubMed 29649928

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04854057
Acronym / sponsor ID: 2020P003328
Conditions: Spinal Cord Injuries
Keywords: hypoxia, spinal cord injury, rehabilitation, function, low oxygen
Study type: Interventional
Recruitment status: TerminatedReason stopped: No funding or personnel for project. We are unable to meet the recruitment goals for this pilot study.
Enrolment: 3 participants (actual)
Lead sponsor: Spaulding Rehabilitation HospitalUniversity, hospital or other
Study start: 3 Mar 2021 (actual)
Primary completion: 22 Oct 2021 (actual)
Study completion: 22 Oct 2021 (actual)
First posted: 22 Apr 2021 (actual)
Results: Posted 10 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	Experimental	Other: AIH - Intermittent Hypoxia - hypoxia air mixture, Other: SHAM - Intermittent Room Air - room air mixture, Device: TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task PracticeRound 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.
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	Experimental	Other: AIH - Intermittent Hypoxia - hypoxia air mixture, Other: SHAM - Intermittent Room Air - room air mixture, Device: TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task PracticeRound 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).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AIH - Intermittent Hypoxia - hypoxia air mixtureParticipants 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.	Other	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 mixtureParticipants 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.	Other	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 PracticeParticipants 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.	Device	Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First, Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First

Primary outcome

Change in Upper Extremity Function
Time frame: 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
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 10 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	1	1
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	2	1

Primary outcome: Change in Upper Extremity Function

Time frame: Once each intervention week (days 5, 10, and 15), and once at follow-up (week 8). Mean (Full Range). Unit: score on a scale

Measure	Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First n = 1	Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First n = 2
Round 1 Day 5	-2 (-2 to -2)	6 (-1 to 13)
Round 1Day 10	5 (5 to 5)	7 (-1 to 15)
Round 1 Day 15	6 (6 to 6)	7 (-3 to 17)
Round 1 Week 8	8 (8 to 8)	-0.5 (-5 to 4)
Round 2 Day 5	-1 (-1 to -1)	11.5 (6 to 17)
Round 2 Day 10	1 (1 to 1)	18 (18 to 18)
Round 2 Day 15	-2 (-2 to -2)	17 (17 to 17)
Round 2 Week 8	0 (0 to 0)	16 (16 to 16)

Population analysed: 1 subject from SHAM+TESS First group dropped out after round 2 day 5.

Primary outcome: Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand

Time frame: Once each intervention week (days 5, 10, and 15), and once at followup (week 8). Mean (Full Range). Unit: kg

Measure	Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First n = 1	Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First n = 2
Round 1 Day 5	-.47 (-.47 to -.47)	1.65 (0 to 3.30)
Round 1 Day 10	-.63 (-.63 to -.63)	1.63 (-0.33 to 3.60)
Round 1 Day 15	-.33 (-.33 to -.33)	2.63 (-0.17 to 5.43)
Round 1 Week 8	.10 (.10 to .10)	3.13 (0.40 to 5.87)
Round 2 Day 5	-.13 (-.13 to -.13)	0.68 (0.00 to 1.37)
Round 2 Day 10	.63 (.63 to .63)	1.53 (1.53 to 1.53)
Round 2 Day 15	.47 (.47 to .47)	-0.43 (-0.43 to -0.43)
Round 2 Week 8	.50 (.50 to .50)	-0.10 (-0.10 to -0.10)

Population analysed: 1 subject from SHAM+TESS First group dropped out after round 2 day 5.

Primary outcome: Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand

Time frame: Once each intervention week (days 5, 10, and 15), and once at followup (week 8). Mean (Full Range). Unit: kg

Measure	Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First n = 1	Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First n = 2
Round 1 Day 5	0 (0 to 0)	0.98 (0 to 1.97)
Round 1 Day 10	0 (0 to 0)	0.30 (0.00 to 0.60)
Round 1 Day 15	.17 (.17 to .17)	0.77 (0.00 to 1.53)
Round 1 Week 8	0 (0 to 0)	2.35 (0.00 to 4.70)
Round 2 Day 5	0 (0 to 0)	-2.28 (-4.57 to 0.00)
Round 2 Day 10	0 (0 to 0)	0.27 (0.27 to 0.27)
Round 2 Day 15	.17 (.17 to .17)	2.40 (2.40 to 2.40)
Round 2 Week 8	0 (0 to 0)	1.37 (1.37 to 1.37)

Population analysed: 1 subject from SHAM+TESS First group dropped out after round 2 day 5.

Adverse events

Time frame: 199 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round 1	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round 2	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round1	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round2	0 of 2 (0%)	1 of 2 (50%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28972191Trumbower 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.
Background: PubMed 29877852Inanici 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.
Background: PubMed 24244094Hoffman 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.
Background: PubMed 29649928Gad 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.
INSPIRE Lab - dedicated to inspire persons with paralysis to move againLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Randy Trumbower, PT, PhD principal investigator

Harvard Medical School (HMS and HSDM)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Upper Extremity Function (time frame: Once each intervention week (days 5, 10, and 15), and once at follow-up (week 8)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04854057, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.