Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

DExterous Hand Control Through Fascicular Targeting (DEFT) - (Human Subjects)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02994160
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : January 20, 2021
Sponsor:
Collaborators:
Defense Advanced Research Projects Agency
Nerves Incorporated, Inc.
Arizona State University
University of Minnesota
Information provided by (Responsible Party):
Jonathan Cheng, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE December 12, 2016
First Posted Date  ICMJE December 15, 2016
Last Update Posted Date January 20, 2021
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2018)
  • Motor Assessment [ Time Frame: weekly beginning 2 days after implantation up to day 180 +/- 30 days ]
    We will ask you to attempt to perform hand movements and positions. The movement trials will consist of simultaneous volitional movements and positioning of both the uninjured/sound limb and the injured/amputated "phantom" limb done. This allows us to have a physical record of exactly what movement is being attempted by the amputated limb. We will record nerve and muscle electrode activity during all of the movement trials. During some movement trials, we will stimulate the LIFE neural electrodes while recording from implanted vs. surface adhesive vs. percutaneous needle muscle electrodes
  • Sensory Assessment [ Time Frame: weekly beginning 2 days after implantation up to day 180 +/- 30 days ]
    We will also perform sensory detection and discrimination trials. Here, you will be asked to report if you detect any sensation during microstimulation (delivering very small electrical signals) via LIFE electrodes. If you do have a sensory perception, you will be asked to describe the quality and strength of the perception, e.g. location, touch, vibration, temperature. You may also be asked to fill out standardized sensory/pain assessments during microstimulation and after microstimulation is turned off. Other stimulation trials that may be done will include single or multiple electrode stimulation to see if subjects can perceive multiple sensory percepts simultaneously. Blinded trials may be done to determine if the subjects are actually perceiving the same percept for a given stimulation paradigm. Other trials may include modulating the stimulation parameters to determine if the sensory percept changes characteristics with varying stimulation paradigms.
  • Sensory-Motor Integration [ Time Frame: weekly beginning 2 days after implantation up to day 180 +/- 30 days ]
    After determining your sensory detection and discrimination parameters, we will ask you to repeat standardized assessments using the existing myoelectric partial hand prosthesis. Microstimulation via LIFE electrodes will be paired with motion or contact during task performance in order to determine whether providing evokes sensation during prosthesis use improves task-based performance.
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2016)
  • Motor Assessment [ Time Frame: weekly beginning 7 days after implantation up to day 90 ]
    We will ask you to attempt to perform hand movements and positions as previously trained. The movement trials will consist of voluntary movements and positioning of both the uninjured/sound limb and the injured/amputated "phantom" limb done at the same time. This allows us to have a physical record of exactly what movement is being attempted by the amputated limb. We will record nerve and muscle electrode activity during all of the movement trials. During some movement trials, we will stimulate the LIFE neural electrodes while recording from implanted vs. surface adhesive vs. percutaneous needle muscle electrodes
  • Sensory Assessment [ Time Frame: weekly beginning 7 days after implantation up to day 90 ]
    We will also perform sensory detection and discrimination trials. Here, you will be asked to report if you detect any sensation during microstimulation (delivering very small electrical signals) via LIFE electrodes. If you do have a sensory perception, you will be asked to describe the quality and strength of the perception, e.g. location, touch, vibration, temperature. You may also be asked to fill out standardized sensory/pain assessments during microstimulation and after microstimulation is turned off. Several types of stimulation trials may be done.
  • Sensory-Motor Integration [ Time Frame: weekly beginning 7 days after implantation up to day 90 ]
    After determining your sensory detection and discrimination parameters (how well you can feel touch and movement), we will ask you to repeat standardized assessments using the existing myoelectric partial hand prosthesis. Microstimulation via LIFE electrodes will be paired with motion or contact during task performance in order to determine whether providing artificial sensation during prosthesis use improves task-based performance.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DExterous Hand Control Through Fascicular Targeting (DEFT) - (Human Subjects)
Official Title  ICMJE DExterous Hand Control Through Fascicular Targeting (DEFT) - (Human Subjects)
Brief Summary

Our goal is to temporarily implant the following groups for 180 +/- 30 days:

  1. Five human partial hand amputees (amputated at the level of the hand) with 2 FAST-LIFE electrodes, one inserted into the motor fascicle of the ulnar nerve and the other into the sensory fascicle.
  2. Five human hand and forearm amputees (amputated at the level of the forearm) with 2 FAST-LIFE electrodes in the ulnar nerve (one in the motor fascicle, one in the sensory fascicle) and 2-5 FAST-LIFE electrodes in the median nerve (one in the motor fascicle, one to four in the remaining sensory fascicles).
Detailed Description

Study Procedures:

Subjects will be consented during a pre-operative visit in the Plastic Surgery Clinic and screened for participation.

Subject pre-operative task training

The study team will train subjects to complete the standardized task-based assessment protocol using the patient's existing myoelectric hand prosthesis. These tests will include:

  • Disabilities of the Arm, Shoulder and Hand
  • Orthotics and Prosthetics User Survey Upper Extremity Functional Status
  • Trinity Amputation Prosthesis Experience Scale
  • Southampton Hand Assessment Procedure
  • Box and Blocks

Screening history and physical Potential human subjects will receive a full medical assessment by the PI. The screening interview will focus on details of the patient's upper extremity condition and comprehensive details of the patient's overall health status. The screening examination will include general examination of the subject.

Pre-operative imaging and diagnostic studies MRI, x-ray, EMG/Nerve conduction studies (NCS) - Each subject who passes the screening H&P will receive the following for their residual limb: magnetic resonance neurogram (MRN), plain x-rays, and EMG/nerve conduction studies. Other studies will be performed in accordance with the UT (University of Texas) Southwestern pre-operative testing protocol, and will depend on the age/gender/medical history of the subject.

MR neurogram will provide information regarding the location and health of amputated peripheral nerve stumps in the residual limb.

Plain x-rays will allow assessment of the bony anatomy of the amputation stump, and suitability for nerve/muscle implants.

Electromyogram/Nerve conduction studies will include motor and sensory nerve conduction of the median and ulnar nerves, and needle exam (voluntary activation EMG) of the residual forearm and hand muscles.

Other studies Based on UT Southwestern pre-operative testing protocol, other studies may be required prior to surgery. CBC (complete blood count) with type and screen will be performed , and HCG (pregnancy test) in females age 15-50. EKG will be performed in males > 40, and females > 50. Chest x-ray will be performed in subjects with a prior history of smoking or lung/chest injury. If surgery is scheduled for more than 90 days after this testing is completed, another set of tests will be needed.

Patient treatment, week of surgery Subjects who have passed all screening measures and who have completed the consent process will be seen for a routine pre-operative H&P up to 30 days before surgery.

Prophylaxis for Methicillin-Resistant Staph Aureus (MRSA) The subject will receive mupirocin ointment to place intranasal, to both nares, twice a day for 5 days prior to surgery.

Implantation surgery Surgery will be performed by Jonathan Cheng, MD, at Clements University Hospital at UT Southwestern Medical Center in Dallas. General anesthesia will be provided by the Department of Anesthesiology at UT Southwestern. Procedures will require placement of a standard catheter for intravenous (IV) access and a urethral (Foley) catheter. Long-lasting neuromuscular blockade will be avoided in the anesthetic regimen. Preoperative IV antibiotic will be administered for infection prophylaxis. One 4-6 inch-long incision will be needed for implantation of nerve (volar forearm) electrodes. In hand-level amputees, two 0.5-1.0cm long dorsal hand incisions will be needed for placement of bipolar fine wire muscle electrodes into the intrinsic hand muscles. In hand-level and forearm-level amputees, two 6-10cm long forearm incisions will be used to place bipolar fine wire muscle electrodes into the residual forearm muscles. The implant lead wires will be tunneled under the skin for a distance, and then placed through the skin. In the forearm-level amputees the wire exit sites may be below or above the elbow depending on the subject's prosthesis configuration. Small counter incisions may be needed along the paths of the lead wires to facilitate placement. The point where the lead wires exit the skin will be dressed with a sterile/antimicrobial dressing used commonly for indwelling vascular access devices (VAD). The implants will be surgically placed under tourniquet control in order to limit bleeding. Following implantation, incisions will be infiltrated with bupivacaine for postoperative analgesia and closed with sutures and skin glue. The hand and forearm will be placed in a protective splint for the first 3 weeks after surgery.

Motor and somatosensory evoked potentials Nerve dissection will be performed under the operating microscope or surgical loupes. The motor and sensory fascicular groups of the ulnar and median nerves will be identified microsurgically as needed for the planned electrode implantations (ulnar only, or ulnar+median) based on their predictable intraneural topography.

Nerve electrode implantation The ulnar and median nerves will be accessed as needed (ulnar only, or ulnar+median) through a volar forearm incision (4-6 inches long). One FAST-LIFE array will be inserted within each of the main motor and sensory fascicular groups of the ulnar nerve. The median nerve will be microdissected to identify the thenar motor fascicle and the 3-4 sensory fascicles that terminate in the hand. One FAST-LIFE array will be inserted within the motor and one or more sensory fascicles of the median nerve.

Muscle electrode implantation The hand intrinsic muscles (hand-level amputations) will be accessed through small dorsal hand incisions (0.5-1cm long). Up to 4 bipolar fine wire electrodes will be placed into the intrinsic muscles and tunneled to a common exit point at the forearm skin.

The forearm muscles (hand-level and forearm-level amputations) will be accessed through two 6-10cm long forearm incisions. Up to 15 bipolar fine wire electrodes will be placed into the residual forearm muscles and tunneled to a common exit point at the forearm skin. In the forearm-level amputees the wire exit sites may be below or above the elbow depending on the subject's prosthesis configuration.

Post-operative care in the hospital Immediately following surgery, subjects will receive routine postoperative care. Overnight hospital stay for up to 2 nights will be optional depending on the level of pain control in the PACU (Post-Anesthesia Care Unit) following surgery. Analgesia will consist of acetaminophen and parenteral and oral narcotics, and pregabalin or gabapentin and/or nortriptyline as needed for neuropathic pain. The operated hand will be elevated at all times. The Foley catheter will be removed as soon as possible following surgery. The IV fluids will be capped as soon as the patient demonstrates adequate oral intake and normal fluid balance. The patient will wear sequential devices on the legs and will walk on a scheduled basis for venous thromboembolism prophylaxis. Prophylactic antibiotics will be administered during the hospital stay up to 24 hours after surgery. Discharge criteria will be met when the patient demonstrates pain controlled adequately by oral analgesics, independent ambulation, and tolerance of oral intake.

X-rays After implantation surgery, plain film x-rays will be obtained of the subject's forearm in order to establish a baseline for the position of implanted electrodes and leads.

Outpatient care The subject will be seen in clinic on a weekly basis following implantation surgery for 3 weeks and then as needed until explantation if there is evidence of local redness, inflammation, serous drainage or skin irritation near the incisions.

Percutaneous leads The electrode leads will be inspected at each weekly visit, and the dressings will be changed using sterile technique based on VAD protocols. If any dressing ever becomes wet, soiled, or leaking, the subject will be instructed to change it. After the first 3 clinic visits wire site dressing changes will be performed by research personnel who have been trained by the principal investigator.

Experimental data collection in implanted subjects (2 - 180 +/- 30 days)

Timing: Human physiology experiments will begin after 2 days following implantation, to allow tissue-electrode interactions to stabilize.

Location: Most of the human physiology experiments will take place at UT Southwestern. Some participants may be asked to travel to the University of Minnesota Bioengineering Lab up to 3 times during the study participation period for the human physiology experiments.

Motor assessment: We will ask subjects to attempt to perform hand movements and positions. The movement trials will consist of simultaneous volitional movements and positioning of both the uninjured/sound limb and the injured/amputated "phantom" limb. We will record nerve and muscle electrode activity during all of the movement trials.

Sensory assessment: We will also perform sensory detection and discrimination trials. Here, the subject will be asked to report if he/she detects any sensation during microstimulation via LIFE electrodes. If they do have a sensory perception, they will be asked to describe the quality and strength of the perception, e.g. location, touch, vibration, temperature. Subjects may also be asked to fill out standardized sensory/pain assessments during microstimulation and after microstimulation is turned off. Other stimulation trials that may be done will include single or multiple electrode stimulation to see if subjects can perceive multiple sensory percepts simultaneously.

Sensory-motor integration: After determining the subject's sensory detection and discrimination parameters, we will ask them to repeat the standardized assessments listed in (4.1.3.2) using the existing myoelectric hand prosthesis.

Explantation surgery - Will be planned for 180 +/- 30 days after implantation. If explantation surgery is scheduled for less than 90 days from the implantation pre-operative testing then the pre-operative testing requirement will be waived. Surgery will be performed by the PI. General anesthesia will be provided by the Department of Anesthesiology at UT Southwestern. Procedures are estimated to last 2-3 hours, and will require placement of a standard catheter for IV access. Preoperative IV antibiotic will be administered for infection prophylaxis. The previous incisions used to place nerve and muscle electrodes will be redeveloped for access to the implanted systems. The implants will be surgically removed under tourniquet control in order to limit bleeding. Following explantation, incisions will be infiltrated with bupivacaine for postoperative analgesia and closed with sutures and skin glue. Postoperative analgesia will be performed as listed above. Jonathan Cheng, MD, will see the subject in clinic once the week following surgery and then as needed. The dressing will be removed and replaced at the first postoperative visit. The incisions will be visually inspected at each visit. The subject will be instructed to contact the research team by phone on week 2 and week 3 to determine if they need to come to the clinic.

Post-participation interview - Subjects may be asked to participate in a recorded video interview conducted by the research team to record their subjective experiences with the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Amputation; Traumatic, Hand
Intervention  ICMJE Other: FastLIFE electrode
Implant temporary FastLIFE electrodes and record the nerve signals that control delicate finger motions and play back the nerve signals that give the hand feelings of touch and movement.
Study Arms  ICMJE Experimental: FastLIFE electrodes
Implant temporary FastLIFE electrodes and record the nerve signals that control delicate finger motions and play back the nerve signals that give the hand feelings of touch and movement.
Intervention: Other: FastLIFE electrode
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2018)
10
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2016)
8
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Criteria for Inclusion of Subjects:

Hand and forearm 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:

  1. Patient has an existing myoelectric hand prosthesis and demonstrates proficiency during daily use
  2. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Debby Noble 214-648-8686 debby.noble@utsouthwestern.edu
Contact: Jennifer Barillas 214-645-8907 jennifer.barillas@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02994160
Other Study ID Numbers  ICMJE STU 092014-061
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jonathan Cheng, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE
  • Defense Advanced Research Projects Agency
  • Nerves Incorporated, Inc.
  • Arizona State University
  • University of Minnesota
Investigators  ICMJE
Principal Investigator: Jonathan Cheng, MD UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP