NCT05505513 Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback?
| NCT ID | NCT05505513 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Utah |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 3 participants |
| Start Date | 2020-12-21 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3 participants in total. It began in 2020-12-21 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators will investigate the device feasibility of human peripheral nerves and muscles recording and stimulation using percutaneous Utah Slanted Electrode Arrays (pUSEAs) implanted into residual peripheral arm nerves and EMG electrodes implanted in the residual muscles of patients with limb amputations in order to determine the ability of the HAPTIX (Hand Proprioception and Touch Interfaces) System to control an upper-extremity prosthesis, and to provide a sense of cutaneous touch and muscle proprioceptive feedback to the amputee.
Eligibility Criteria
Inclusion Criteria: * at least 18 years of age and less than 65 years of age * unilateral and bilateral traumatic or elective upper extremity amputations at the transradial level Exclusion Criteria: * incarceration * pregnancy * inability to consent * psychiatric comorbidity * medical conditions that significantly increase the risk of adverse effects of general anesthesia
Contact & Investigator
Douglas Hutchinson, M.D.
PRINCIPAL INVESTIGATOR
University of Utah Orthopaedics
Frequently Asked Questions
Who can join the NCT05505513 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05505513 currently recruiting?
Yes, NCT05505513 is actively recruiting participants. Contact the research team at Douglas.Hutchinson@hsc.utah.edu for enrollment information.
Where is the NCT05505513 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT05505513 clinical trial?
NCT05505513 is sponsored by University of Utah. The principal investigator is Douglas Hutchinson, M.D. at University of Utah Orthopaedics. The trial plans to enroll 3 participants.