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NCT04243044
Influence of Transcutaneous Spinal Stimulation Intensity on Spasticity After SCI
NA trial testing Transcutaneous spinal stimulation in Spinal Cord Injuries in 21 participants. Completed in 1 December 2023.
1 December 2023
Quick facts
| Lead sponsor | Shepherd Center, Atlanta GA |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 8 April 2022 |
| Primary completion | 1 December 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Transcutaneous spinal stimulation
Conditions studied
- Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
Sponsor
Shepherd Center, Atlanta GA
Who can join
16 and older, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Transcutaneous spinal stimulation (TSS) is a form of electrical stimulation delivered over the skin of the spine that may be valuable for reducing spasticity without the side effects of antispasticity medications. The intensity of stimulation, or dose, that promotes the best response is not known. Understanding the response to different intensities of stimulation and how they affect spasticity will help guide rehabilitation for persons with SCI. Therefore, this study aims to identify the effects of TSS as a non-drug intervention for spasticity management.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Optimizing transcutaneous spinal stimulation: excitability of evoked spinal reflexes is dependent on electrode montage.
Thatcher KL, Nielsen KE, Sandler EB, Daliet OJ, et al · · 2025 · cited 3× · PMID 39762915 · DOI 10.1186/s12984-024-01524-5 -
Transcutaneous Spinal Stimulation Modulates Spinal Reflex Circuit Excitability in Persons with Spinal Cord Injury.
Sandler EB, Iddings JA, Minassian K, Field-Fote EC. · · 2025 · cited 1× · PMID 41007758 · DOI 10.3390/biomedicines13092195 -
Immediate Effects of Transcutaneous Spinal Stimulation on Stretch-Induced Spasticity in Persons with Spinal Cord Injury.
Sandler EB, Iddings JA, Field-Fote EC. · · 2025 · PMID 41300207 · DOI 10.3390/brainsci15111201 -
Optimizing Transcutaneous Spinal Stimulation: Excitability of Evoked Spinal Reflexes is Dependent on Electrode Montage
Thatcher KL, Nielsen KE, Sandler EB, Daliet OJ, et al · · 2024 · DOI 10.21203/rs.3.rs-4719031/v1
Verify or expand the search:
- PubMed search for NCT04243044
- 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.
- NCT04043715 — Comparison of Transcutaneous and Epidural Spinal Stimulation for Improving Function · NA · withdrawn
- 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 Shepherd Center, Atlanta GA trials
Trials by the same sponsor.
- NCT06214208 — Influence of Spinal Stimulation Frequency on Spasticity, Motor Control, and Pain After Spinal Cord Injury · NA · recruiting
- NCT04238013 — Neuromodulation of Ankle Muscles in Persons With SCI · NA · terminated
- NCT04777149 — Random Noise Stimulation to Enhance Cortical Drive & Improve Hand Function · NA · completed
- NCT06126549 — Comparison of Two Interventions for Caregivers of Patients With Acquired Brain Injury · NA · completed
- NCT04130295 — Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury · NA · completed
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 NCT04243044 (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 Shepherd Center, Atlanta GA
- Last refreshed: 7 March 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/NCT04243044.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing