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Movement and Sensation for Advanced Prosthetic Hands

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259386
Recruitment Status : Terminated (Problem with obtaining microarrays, which are essential components needed to conduct this study.)
First Posted : August 23, 2017
Last Update Posted : December 11, 2018
Sponsor:
Collaborators:
United States Department of Defense
Arizona State University
Information provided by (Responsible Party):
Shelley S. Noland, Mayo Clinic

Brief Summary:
The purpose of this study is to learn more information about nerves. This study is also designed to learn how the information in nerves could be used to develop new prosthetic devices.

Condition or disease Intervention/treatment
Amputation Device: Microelectrode array

Detailed Description:

The general design of the study is broken down into two parts: the pre- and post-implantation schedules:

During the 30 days before implantation the participant will be asked to take home a small computer with an Oculus Rift headset and Leap Motion hand tracker. The participant will be asked to use these items five (5) times a week for 30 minutes a session and interact with a displayed virtual reality environment. In this environment the participant will move their intact hand and the Leap Motion will display the hand movements in the virtual environment with the intact hand movements being mirrored between two hand facsimile. The participant will be instructed to move and stretch both their phantom and intact hand in a mirrored fashion. The purpose of these exercises are to allow the participant to become accustomed to the virtual reality setup (equipment and display) as well as providing a mirror box like effect where the virtual hand facsimile for their phantom hand is mapped to their body.

The second phase of the general design continues for 30-90 days post-implantation. We shall perform electrophysiological recordings from a single microelectrode array implanted into either the median, radial, or ulnar nerve. Neural signals (single and compound action potentials) evoked by variegated movements of the fingers and thumb will be recorded on the implanted microelectrode array. By recording electrical signals from the nerves the investigators hope to decode finger movements in real-time using machine learning algorithms. The participants will be asked to complete tasks in controlled virtual environment during the training phase. The virtual environment, which includes virtual arms and hands, will be presented to the participant via the Oculus rift, a pair of virtual reality goggles. The task will require recording the position of arms in space which will be accomplished using the Vicon motion capture system that will use infra-red reflecting markers attached to the participant's arms. The investigators will also use a marker-less motion capture system, Leap Motion, to track the specific movements of the intact hand. Post training, the investigators aim to perform real-time decoding of finger movements in the virtual reality environments.

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using Arrays of Microelectrodes Implanted in Residual Peripheral Nerves to Provide Dexterous Control of, and Modulated Sensory Feedback From, a Hand Prosthesis
Actual Study Start Date : September 11, 2017
Actual Primary Completion Date : October 24, 2018
Actual Study Completion Date : October 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Group/Cohort Intervention/treatment
Transradial or Transhumeral amputees
High-count microelectrode arrays are implanted into the upper limb peripheral nerves of transradial or transhumeral amputees.
Device: Microelectrode array
Microelectrode array implanted in area of amputation of either transradial or transhumeral amputees. This device is not designed to collect data on safety and effectiveness but rather, the device is a tool to assist in the sensory and motor properties of peripheral nerve stump fibers in amputees and is considered basic physiological research. This study was determined to be IDE exempt by the FDA; the study is considered basic physiological research.




Primary Outcome Measures :
  1. Number of subjects for whom the investigators can decode finger movements [ Time Frame: From 44-104 days post-implantation ]
    High-count microelectrode arrays are implanted into upper limb peripheral nerves of transradial and transhumeral amputees. Direct micro-stimulation of peripheral nerves will be done using the microelectrode array.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
These are patients that have previously undergone a transradial or transhumeral amputation.
Criteria

Inclusion Criteria:

1. Patient has previously undergone a transradial (below elbow) or transhumeral (above elbow) amputation.

Exclusion Criteria:

  1. Pregnancy
  2. Incarceration
  3. Inability to consent
  4. Serious, untreated comorbidity
  5. Patient is diagnosed with a medical condition(s) that seriously increase the risk of electrode implantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259386


Locations
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United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
Arizona State University
Tempe, Arizona, United States, 85287
Sponsors and Collaborators
Mayo Clinic
United States Department of Defense
Arizona State University
Investigators
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Principal Investigator: Shelley Noland, MD Mayo Clinic
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Responsible Party: Shelley S. Noland, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03259386    
Other Study ID Numbers: 14-007456
W81XWH-13-PRORP-TRA ( Other Grant/Funding Number: CDRMP )
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes