Who is sponsoring NCT04854057?

NCT04854057 is sponsored by Spaulding Rehabilitation Hospital.

What drugs are being tested in NCT04854057?

Interventions in NCT04854057: AIH - Intermittent Hypoxia - hypoxia air mixture, SHAM - Intermittent Room Air - room air mixture, TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task Practice.

What condition does NCT04854057 study?

NCT04854057 studies Spinal Cord Injuries.

Is NCT04854057 still recruiting?

NCT04854057 is currently terminated. Last updated 10 January 2024.

Are results published for NCT04854057?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-01-10 · How we verify

NCT04854057

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated NA Results posted Last updated 10 January 2024

What this trial tests

NA trial testing AIH - Intermittent Hypoxia - hypoxia air mixture in Spinal Cord Injuries in 3 participants. Terminated before completion.

Timeline

3 March 2021

Primary endpoint
22 October 2021

22 October 2021

Quick facts

Lead sponsor	Spaulding Rehabilitation Hospital
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	3
Start date	3 March 2021
Primary completion	22 October 2021
Estimated completion	22 October 2021
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

Spinal Cord Injuries — all drugs for Spinal Cord Injuries →

Sponsor

Spaulding Rehabilitation Hospital

Who can join

Adults 18 to 65, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Upper Extremity Function Primary · 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.

Round 1 Day 5

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	-2	-2 – -2
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	6	-1 – 13

Round 1Day 10

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	5	5 – 5
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	7	-1 – 15

Round 1 Day 15

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	6	6 – 6
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	7	-3 – 17

Round 1 Week 8

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	8	8 – 8
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	-0.5	-5 – 4

Round 2 Day 5

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	-1	-1 – -1
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	11.5	6 – 17

Round 2 Day 10

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	1	1 – 1
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	18	18 – 18

Round 2 Day 15

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	-2	-2 – -2
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	17	17 – 17

Round 2 Week 8

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	0	0 – 0
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	16	16 – 16

Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand Primary · 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.

Round 1 Day 5

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	-.47	-.47 – -.47
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	1.65	0 – 3.30

Round 1 Day 10

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	-.63	-.63 – -.63
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	1.63	-0.33 – 3.60

Round 1 Day 15

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	-.33	-.33 – -.33
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	2.63	-0.17 – 5.43

Round 1 Week 8

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	.10	.10 – .10
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	3.13	0.40 – 5.87

Round 2 Day 5

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	-.13	-.13 – -.13
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	0.68	0.00 – 1.37

Round 2 Day 10

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	.63	.63 – .63
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	1.53	1.53 – 1.53

Round 2 Day 15

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	.47	.47 – .47
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	-0.43	-0.43 – -0.43

Round 2 Week 8

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	.50	.50 – .50
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	-0.10	-0.10 – -0.10

Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand Primary · 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.

Round 1 Day 5

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	0	0 – 0
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	0.98	0 – 1.97

Round 1 Day 10

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	0	0 – 0
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	0.30	0.00 – 0.60

Round 1 Day 15

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	.17	.17 – .17
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	0.77	0.00 – 1.53

Round 1 Week 8

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	0	0 – 0
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	2.35	0.00 – 4.70

Round 2 Day 5

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	0	0 – 0
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	-2.28	-4.57 – 0.00

Round 2 Day 10

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	0	0 – 0
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	0.27	0.27 – 0.27

Round 2 Day 15

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	.17	.17 – .17
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	2.40	2.40 – 2.40

Round 2 Week 8

Group	Value	95% CI
Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	0	0 – 0
Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First	1.37	1.37 – 1.37

Adverse events — posted to ClinicalTrials.gov

Time frame: 199 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round 1

Serious: 0/1 (0%)

Deaths: 0/1

Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round 2

Serious: 0/1 (0%)

Deaths: 0/1

Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round1

Serious: 0/2 (0%)

Deaths: 0/2

Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round2

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (1 terms — click to expand)

Reaction	System	Intermittent Hypoxia (AIH)…	Intermittent Hypoxia (AIH)…	Intermittent Room Air (SHA…	Intermittent Room Air (SHA…
Pressure ulcer	Skin and subcutaneous tissue disorders	—	—	—	—

Data from ClinicalTrials.gov NCT04854057 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Combining Therapeutic Strategies to Treat the Injured Spinal Cord: A Translational Perspective.
Sherman BC, Schmidt Read M, Hoh DJ, Guest JD, et al · · 2025 · cited 2× · PMID 40929022 · DOI 10.1177/08977151251371710

Verify or expand the search:

Other recruiting trials for Spinal Cord Injuries

Currently open trials in the same condition.

NCT07109804 — Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury · NA · recruiting
NCT07472985 — Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial · NA · recruiting
NCT07210411 — Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury · NA · recruiting
NCT07488793 — Remote Ischemic Conditioning for PwSCI · NA · recruiting
NCT07536386 — Self-balancing Personal Exoskeleton for SCI (WIP) · NA · recruiting

Other Spaulding Rehabilitation Hospital trials

Trials by the same sponsor.

NCT04940403 — BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors: · NA · not yet recruiting
NCT06193317 — Effects of taVNS on Fibromyalgia Pain · NA · not yet recruiting
NCT07483320 — Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy · NA · not yet recruiting
NCT06797154 — A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors · NA · recruiting
NCT06826781 — Evaluating Q-Collar Effects on Brain Blood Flow Control During Exercise · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04854057 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Spaulding Rehabilitation Hospital
Last refreshed: 10 January 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04854057.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04854057

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Spinal Cord Injuries

Other Spaulding Rehabilitation Hospital trials

Verify against primary sources