Evaluating a new prosthesis control system for amputees

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• NHS Greater Glasgow and Clyde
  Glasgow, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.