Last reviewed · How we verify
NCT04043715
Comparison of Transcutaneous and Epidural Spinal Stimulation for Improving Function
NA trial testing Transcutaneous spinal stimulation in Spinal Cord Injuries. Withdrawn.
31 October 2022
Quick facts
| Lead sponsor | University of Washington |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 August 2019 |
| Primary completion | 31 October 2022 |
| Estimated completion | 31 October 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Transcutaneous spinal stimulation
- Epidural spinal stimulation
Conditions studied
- Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
- Spinal Cord Diseases — all drugs for Spinal Cord Diseases →
- Central Nervous System Diseases — all drugs for Central Nervous System Diseases →
- Nervous System Diseases — all drugs for Nervous System Diseases →
Sponsor
University of Washington
Who can join
Adults 21 to 70, any sex, with Spinal Cord Injuries or Spinal Cord Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Incomplete spinal cord injuries (SCI) are the most frequent neurologic category, comprising 66.7% of all SCI cases. People with incomplete SCI may retain some ability to move the legs and therefore the capacity to regain walking. Studies that show functional improvement in locomotion via electrical stimulation of lumbosacral circuits suggest that the underlying mechanisms are neuromodulation of lumbosacral spinal cord automaticity and sensory feedback. Both epidural and transcutaneous spinal stimulation are demonstrating exciting potential to improve limb function for people after chronic SCI. Available treatment options for SCI are less than satisfactory and most often do not achieve full restoration of function. Recent experimental results suggest an exciting new approach of using electrical spinal stimulation to enable users to regain control of their weak or paralyzed muscles. Using surgically-implanted electrodes, epidural stimulation results in remarkable improvements of lower extremity function as well as autonomic functions such as bladder function and sexual function. In addition to epidural stimulation, over only the last few years a novel strategy of skin surface electrical spinal stimulation has also demonstrated exciting potential for improving walking function. Using a high-frequency stimulation pulse, current can pass through the skin without discomfort and activate the spinal cord; this results in patterned stepping movements for people without SCI and improved lower extremity function following SCI. This study will directly compare skin-surface transcutaneous stimulation with implanted epidural stimulation for improving lower extremity function.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Neurosensory Prosthetics: An Integral Neuromodulation Part of Bioelectronic Device.
Ezeokafor I, Upadhya A, Shetty S. · · 2021 · cited 6× · PMID 34867141 · DOI 10.3389/fnins.2021.671767
Verify or expand the search:
- PubMed search for NCT04043715
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Transcutaneous spinal stimulation
Trials testing the same drug.
- NCT04243044 — Influence of Transcutaneous Spinal Stimulation Intensity on Spasticity After SCI · NA · completed
- NCT03509558 — Transcutaneous Spinal Stimulation and Exercise for Locomotion · NA · recruiting
- NCT03184792 — Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury · NA · completed
- NCT03240601 — Spinal Cord Stimulation to Augment Activity Based Therapy · NA · completed
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 University of Washington trials
Trials by the same sponsor.
- NCT07430852 — Inherited and Environmental Risks Acting on Body Weight · NA · not yet recruiting
- NCT07466498 — Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Canc · Phase 2 · not yet recruiting
- NCT06422299 — Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Youn · NA · not yet recruiting
- NCT07322341 — SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer · Phase 2 · not yet recruiting
- NCT07332351 — Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04043715 (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 University of Washington
- Last refreshed: 26 April 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/NCT04043715.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing