Our Clinical Trials

Amputee Research currently has two clinical trials open for enrollment:

  • The TR Surgical Trial is exploring the best method to reduce residual and phantom limb pain, which many amputees struggle with.
  • Our Transradial Prosthetic Hand Trial is testing methods to improve muscle control of multi-articulated prosthetic hands.

Please read the descriptions of these trials below and reach out to us if you have any questions. We will be excited to speak with you. If you do not think these trials are right for you, but would like to receive notification about future trials please just say “hello” from our contact page.

TR Surgical Trial

We are seeking amputees for a clinical trial to evaluate the best surgical method to treat chronic pain associated with limb amputation. This study could influence how all post amputation pain treatment surgery is performed as well as point the way to a new method of performing amputations that result in less pain from the start.

Why is this study being done?

Many amputees develop residual and phantom pain in their amputated limb, making it difficult for some to wear prostheses. The pain comes from cut nerve endings. These nerves, previously used to control the amputated limb, remain active, constantly sending signals to the brain. The cut but active nerves develop painful growths called “neuromas.” Symptoms of amputee neuroma pain include pain when touching the end of the amputated limb. Some people use the words “burning,” “aching,” “zingers, “or “moving pain” to describe this feeling.

We are studying two different types of surgery to determine which method is the best treatment to reduce pain from damaged nerve endings in amputated limbs.

Traction Neurectomy with Burying This surgical technique is considered the current standard of care for alleviating pain from damaged nerves in an amputated limb. The surgery involves removing the scarred nerve ending (neuroma) and burying the nerve ending into a nearby muscle. By burying the cut nerve into a muscle, it hides the end of the nerve from being touched.

Targeted Muscle Reinnervation (TMR) Recently, a new surgery has been developed called Targeted Muscle Reinnervation (TMR). This surgery removes the neuroma and essentially plugs the newly shortened nerve into the functioning nerve of a nearby muscle. Connecting the damaged nerve to the functioning nerve of a muscle allows it to then grow into, or reinnervate, the target muscle. This has been successful for amputees in helping reduce their pain.

Who is eligible to participate in this study?

In order to participate in this study you must:

  • Be 18 years or older.
  • Be able to read and comprehend either English or Spanish.
  • Have an upper limb amputation above the wrist or a lower limb amputation above the ankle.
  • Have been diagnosed with neuroma or nerve pain by your physician or currently experiencing pain but have not been formally diagnosed.

What is involved in the study?

The first step is setting up a phone call between prospective patients and one of our study coordinators to discuss past medical history and answer any questions about the trial you might have.

The next step is to set up an initial appointment at one of our study sites for an evaluation. A physician will review your medical history and determine if you’re a good candidate to join the study. If you qualify and agree to participate we will review the consent form with you and upon signing it you will be officially enrolled in the study.

Before surgery, participants will have an MRI and also complete a short survey about pain levels. Also two weeks before surgery there will be some blood work and an EKG done to make sure all patients are healthy enough for surgery. After surgery patients will stay in the hospital overnight for observation. A few days after surgery there will be a follow up appointment with the doctor to ensure you are healing properly.

Once the surgery is performed, we want to continually monitor the success of the surgery and determine how pain levels change. We do this by having patients complete an online survey. Post-surgery surveys will be sent out at 1 month, 3 months, 6 months, 9 months, 1 year, and then every 6 months until the end of the study. Participants will also have an MRI one year after the surgery.

Where is this trial occurring?

This trial is funded by The Department of Defense (DoD) Office of Congressionally Directed Medical Research and is open to both civilian and military amputees.

There are currently six hospitals where this trial will be occurring:

  • Northwestern Medicine (Chicago, Illinois) – Currently recruiting patients for study
  • Georgetown University Medical Center (Washington, DC) – Currently recruiting patients for study
  • The Ohio State University Wexner Medical Center (Columbus, Ohio) – Not yet recruiting
  • San Antonio Military Medical Center (San Antonio, Texas)* – Currently recruiting patients for study
  • Vanderbilt University Medical Center (Nashville, Tennesee) – Not yet recruiting
  • Walter Reed National Military Medical Center (Bethesda, Maryland/Washington, DC)* – Currently recruiting patients for study

*These sites are only available to active duty military, veterans, and other qualifying personnel


Frequently Asked Questions

Is this covered by insurance?
Can I choose which surgery I receive?
What if I do not live close to a study site?
How long before I can wear my prosthesis?
Will results of the study be provided to me?
Where can I get more information?

Transradial Prosthetic Hand Trial

We are seeking individuals who have a transradial (below-elbow) amputation for a clinical trial to test alternative methods of operating multi-articulating hand prosthesis. The purpose of this study is to make hand prosthesis easier to use and more functional.

Why is this study being done?

We are investigating the effectiveness of using Targeted Muscle Reinnervation (TMR) surgery and Pattern Recognition Control to enhance the use of multi-articulating prosthetic hands.

Targeted Muscle Reinnervation (TMR) is a surgical technique that transfers damaged nerves from the amputation site into the functioning nerves of a nearby muscle. Connecting the damaged nerves to the functioning nerves of a muscle allows them to grow into (reinnervate) the target muscle. TMR creates additional muscle control sites with the intention of making prosthesis control more intuitive and allowing more prosthetic functions.

Pattern Recognition Control is programming prosthesis with advanced computer algorithms that learn to recognize and distinguish your distinct muscle patterns. As the prosthesis learns your muscle patterns, you simply have to try and make the desired movement and the prosthesis will then respond with the correct movement.

Who is eligible to participate in this study?

In order to participate in this study, you must:

  • Be 18 years or older.
  • Be able to read and comprehend English.
  • Have a below-elbow amputation.
  • Be available for 6 visits over the course of 12 months.
  • Have previous experience using a myoelectric prosthesis (preferred).

What is involved in the study?

The first step is setting up a phone call between prospective patients and one of our study coordinators to discuss past medical history and answer any questions about the trial you might have.

The next step is to set up an initial appointment at one of our study sites for an evaluation. A physician will review your medical history and determine if you’re a good candidate to join the study. If you qualify and agree to participate, we will review the consent form with you and upon signing it you will be officially enrolled in the study.

This study involves several multi-day visits to learn how to use the prosthesis. Some of these visits will be at one of our study sites, while other visits may take place at or near your home. Study coordinators will determine the best location.

Phase 1 – During the first phase of the study, a prosthetist will fit you with a custom-made socket and a multifunctional hand system. You will receive 1-3 days of training to learn how to control the prosthesis with “conventional control.” For conventional control, one electrode will be placed over your forearm flexors; another will be placed over your forearm extensors to control the prosthesis movement. You will then return home for an 8-week home-use trial where you will use the prosthesis for an average of 2 hours per day. Following the first 8-week home-use trial, you will be asked to complete a series of outcome tests with the hand system. Afterwards, we will change the control of the prosthesis to “pattern recognition control.” For “pattern recognition control,” a grid of 8 electrodes will be used to record your muscle activity. You will then complete another training session at one of the study sites to learn the new control method, followed by 8-weeks of home use, and a series of outcome tests to measure functionality.

Phase 2 – For Phase 2, you will return to one of the three study sites to receive Targeted Muscle Reinnervation (TMR) surgery.

Six months post-surgery, you will return to one of the study sites to be re-trained on “pattern recognition control” and then will repeat the 8-week home trial, and outcome tests to measure functionality. After the initial 8-week post-surgery test you will continue to use the multi-articulating hand prosthesis with “pattern recognition control” another three to four months.

All participants will test the prosthetic hand system pre-operatively using Conventional Control and Pattern Recognition and then post-operatively using Pattern Recognition.

Where is this trial occurring?

This study is funded by The National Institutes of Health (NIH) and is open to both civilians and military service members. There are currently three hospitals recruiting subjects for this study:

  • Rehabilitation Institute of Chicago (RIC) / Northwestern Memorial Hospital (Chicago, Illinois) – Currently recruiting patients for study
  • Walter Reed National Military Medical Center (Bethesda, Maryland / Washington, DC)* – Currently recruiting patients for study
  • San Antonio Military Medical Center (San Antonio, Texas)* – Currently recruiting patients for study

*These sites are only available to active duty military, veterans, and other qualifying personnel


Frequently Asked Questions

Will the procedures involved for this study be covered by insurance?
What if I do not live close to a study site?
How long after undergoing TMR surgery before I can wear my prosthesis?
Will I receive any financial and/or medical benefit from participating in this study?
Where can I get more information?