Improving hand control for amputees using advanced electrodes

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 aims to enhance hand control in amputees by temporarily implanting FAST electrodes in the ulnar and median nerves of participants with varying levels of upper limb amputations. The study will involve a thorough pre-operative assessment, including medical history, imaging, and nerve conduction studies, to ensure participant eligibility. A total of 15 participants will be recruited, with specific groups based on the level of amputation, to evaluate the effectiveness of the electrode implants over a period of approximately 540 days.

Why it matters

Who can join: the full rules

Criteria for Inclusion of Subjects:

Hand, forearm and arm amputees:

1. Male or female, age 18 and older, of any race or ethnicity
2. Able and willing to sign Consent
3. Able and willing to participate in all study activities including implantation, testing and explantation of the study device.
4. Able to communicate effectively in English without an interpreter

After preliminary screening subjects will be assessed for the following inclusion criteria:

Overall and phantom pain are well-controlled and not incapacitating

Criteria for Exclusion of Subjects:

1. If MR neurogram and EMG/NCS study show nerve or muscle dysfunction/injury at a higher level than anticipated based on the appearance of the physical amputation stump, the subject may be excluded from the study due to adverse neuromuscular anatomy which would preclude use of the proposed experimental electrode implants. The radiographs will be used to confirm suitability of the amputation stump configuration. If the bony anatomy of the amputation stump is found to be unsuitable, the patient may be excluded from the study.
2. Subjects who have a history of cardiac arrhythmia will be excluded from the study.

Where it's running

• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Jonathan Cheng, MD — University of Texas Southwestern Medical Center
• Study coordinator: Debby Noble
• Email: debby.noble@utsouthwestern.edu
• Phone: 214-648-8686

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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.