BridgeMD
New treatment option for Upper Limb Amputees
Official title Proprioceptive Sensorimotor Integration With Neural Interfaces for Hand Prostheses
ClinicalTrials.gov ID: NCT04947462
What this study is testing
- What it's testing
- The purpose of this study is to characterize proprioceptive sensations in the missing limb of upper limb amputees using nerve stimulation, and to develop advanced controllers for moving a prosthesis. Proprioceptive sensations are the sensations that tell individuals where their hand is in space, and if it is moving.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Unilateral upper limb amputation above or below the elbow with fully healed and healthy surgical sites
- Viable peripheral nerve function in the residual nerves serving the limb
- Volitional activity of the residual muscles in the amputated limb or actuating movement of the limb
- Medically fit to undergo general anesthesia
- Fitted with a prosthesis by a certified prosthetic and orthotic specialist (CPO) and at least one month of experience using a prosthesis
You likely can't join if
- Bilateral upper limb amputation, unless the amputation on the contralateral side only involves missing digits but does not qualify as a partial hand...
- Inability to speak English
- Medically unfit to undergo surgery
- Pregnancy, or those who are of childbearing potential, unwilling to prevent pregnancy during the trial
- Uncontrolled diabetes (HgbA1c\>8.0%)
- History of neuropathy and/or radiculopathy in the target limb
See the full eligibility criteria
- Unilateral upper limb amputation above or below the elbow with fully healed and healthy surgical sites
- Viable peripheral nerve function in the residual nerves serving the limb
- Volitional activity of the residual muscles in the amputated limb or actuating movement of the limb
- Medically fit to undergo general anesthesia
- Fitted with a prosthesis by a certified prosthetic and orthotic specialist (CPO) and at least one month of experience using a prosthesis
- Willingness and availability to follow the study protocol
- Willingness to undergo psychological evaluation, if recommended by study surgeons or investigators, to determine that the participant is mentally competent and capable of completing the study-related activities
- Bilateral upper limb amputation, unless the amputation on the contralateral side only involves missing digits but does not qualify as a partial hand amputation
- Inability to speak English
- Medically unfit to undergo surgery
- Pregnancy, or those who are of childbearing potential, unwilling to prevent pregnancy during the trial
- Uncontrolled diabetes (HgbA1c\>8.0%)
- History of neuropathy and/or radiculopathy in the target limb
- Active infection or open sores on the residual limb
- History of frequent infection or sores with unknown cause
- Inability to provide informed consent or follow experimental protocols
- Severe pain that would prevent the participant from completing study-related activities
- Poor surgical candidate
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.