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NCT07032753
Neuromusculoskeletal Interface for Bionic Arms
NA trial testing eOPRA in Amputation in 12 participants. Not yet recruiting.
31 May 2028
Quick facts
| Lead sponsor | Shirley Ryan AbilityLab |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 12 |
| Start date | 1 January 2026 |
| Primary completion | 31 May 2028 |
| Estimated completion | 31 May 2029 |
| Sites | 1 location across United States |
Drugs / interventions tested
- eOPRA
- OPRA
- eOPRA with sensory feedback
- eOPRA without sensory feedback
Conditions studied
- Amputation — all drugs for Amputation →
- Amputation, Traumatic — all drugs for Amputation, Traumatic →
- Amputation, Surgical — all drugs for Amputation, Surgical →
- Upper Limb Amputation Above Elbow (Injury) — all drugs for Upper Limb Amputation Above Elbow (Injury) →
Sponsor
Shirley Ryan AbilityLab — full company profile →
Who can join
Adults 18 to 70, any sex, with Amputation or Amputation, Traumatic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The overall objective of this proposal is to perform a first-in-human home trial of the Electronic Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations who have had Targeted Muscle Reinnervation (TMR) surgery and use a pattern recognition-controlled myoelectric prosthesis. The purpose of the study is to capture preliminary safety and effectiveness information on the e-OPRA device when used with the prosthetic systems. The investigators expect that the e-OPRA implant system will be safe and provide clinically and statistically significant improvements in control and comfort. Specifically, the investigators hypothesize that the e-OPRA system will (1) allow for training of more functional prosthesis controllers, (2) provide more stable electromyographic (EMG) signals, reducing the need to recalibrate the prosthetic control system, and (3) be more comfortable, as it does not require a tethered arm-band to record surface EMG signals. Phase 1: Perform TMR and e-OPRA surgeries in 8 persons with transhumeral amputations. Phase 2: Perform a randomized cross-over study to compare the OPRA and e-OPRA system (without sensory feedback) in 8 transhumeral amputees who have received TMR. Phase 3: Perform a randomized cross-over study to compare the e-OPRA system with and without sensory feedback in 8 transhumeral amputees who have received TMR.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07032753
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Amputation
Currently open trials in the same condition.
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- NCT07265154 — Gait Training and Artificial Intelligence · NA · recruiting
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- NCT07347561 — A Comparison of Myoelectric and Bionic Hands · recruiting
- NCT07364266 — Analgesic Amputation for Algodystrophy: Feedback From a Case Series · active not recruiting
Other Shirley Ryan AbilityLab trials
Trials by the same sponsor.
- NCT07434492 — Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy · Phase 2 · not yet recruiting
- NCT07433023 — tSCS and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy · Phase 2 · not yet recruiting
- NCT06999213 — Lower Limb ExoNET: Development and Evaluation for Gait Assistance With Stroke Survivors · EARLY_PHASE1 · not yet recruiting
- NCT07223710 — Improving Walking After Spinal Cord Injury · Phase 1, PHASE2 · not yet recruiting
- NCT07364773 — Enhancing Rehabilitation Participation in Patients With SCI/D Using Motivational Interviewing · 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)
- Trial protocol + status: ClinicalTrials.gov NCT07032753 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shirley Ryan AbilityLab
- Last refreshed: 24 June 2025
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/NCT07032753.
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