Improving hand control for amputees using advanced electrodes
DExterous Hand Control Through Fascicular Targeting (DEFT) - (Human Subjects)
This study is testing if special electrodes can improve hand control for people with different types of upper limb amputations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT02994160 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include male and female amputees aged 18 and older who have well-controlled pain and are willing to undergo the implantation and testing of the electrodes.
Not a fit: Patients with significant nerve or muscle dysfunction that would prevent the use of the experimental electrode implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the functionality and quality of life for amputees by restoring more natural hand movements.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving prosthetic control through neural interfaces, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Dallas, Texas
- 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
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.