Evaluating a new prosthesis control system for amputees
Clinical Feasibility of the IMES Transradial Prosthesis
This study is testing a new way for amputees to control a prosthetic hand using special sensors implanted in their arm muscles to see how well it works in everyday life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Össur Iceland ehf Industry-sponsored |
| Locations | 1 site (Glasgow) |
| Trial ID | NCT04936789 on ClinicalTrials.gov |
What this trial studies
This study assesses the feasibility of using implanted myoelectric sensors (IMES) to control a transradial prosthesis in amputee subjects. The IMES will be implanted into the residual forearm muscles of three participants, allowing them to wirelessly transmit muscle signals to an electromechanical prosthetic wrist and hand. After a recovery period, subjects will undergo training and then use the custom-fit prosthesis at home for approximately four months, with follow-up visits to evaluate usability and functionality.
Who should consider this trial
Good fit: Ideal candidates are individuals with unilateral acquired transradial amputations who have sufficient residual muscle for implantation.
Not a fit: Patients with neurological disorders or other conditions that may hinder accurate control of the prosthesis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the control and functionality of prosthetic limbs for amputees.
How similar studies have performed: While the use of myoelectric sensors in prosthetics is established, this specific approach with IMES is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (unilateral acquired transradial) amputation * residual limb size requirements to fit investigational device componentry * at least 6 residual muscle locations available for implantation * good compliance with health service (rehabilitation) * willing to undergo surgical implantation of IMES Sensor implants * experience with myoelectric upper limb prostheses * using own myoelectric device approximately 6-8h/day * able to provide informed consent and attend the study visits Exclusion Criteria: * any condition which in the opinion of the investigator poses a risk to health * neurological disorder that may prohibit accurate control * major injury proximal to the level of amputation * neuromuscular disorder * nerve transection or palsy that may cause de-innervation of muscles planned for implantation * allergy to implanted materials * existing active implant
Where this trial is running
Glasgow
- NHS Greater Glasgow and Clyde — Glasgow, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Aidan Roche, MD — NHS; University of Edinburgh
- Study coordinator: Daire McGuinness, BSc
- Email: dmcguinness@ossur.com
- Phone: 00441315070097
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.