12 Clinical Trials for Various Conditions
Today, prosthetic hands are numb. They provide no tactile or proprioceptive sensory information back to the user. The lack of sensory feedback has been shown to reduce the utility of a prosthesis by half. The prosthesis is seen as a tool, not as an incorporated part of the body schema. Only now are there chronically-implantable technologies which can provide physiologically appropriate sensory feedback to upper limb amputees to recreate tactile and proprioceptive percepts. These sensations are the building blocks to enable the embodiment of the device. Furthermore, newly developed outcome measures are now available which can detail the improved embodiment such neural interfaces can create. The investigator's mission is to enable the embodiment of artificial devices using peripheral nerve stimulation and thereby close the gap between the experience of our intact physiological systems and those using prosthetic remedies. This investigation of embodiment for upper limb amputees is organized into three main areas of work including 1) normative data collection, 2) device development, and 3) characterization of embodiment using peripheral nerve stimulation. The normative data collection will quantify the embodiment of conventional cosmetic, body-powered, and myoelectric prosthetic hand options using a modified Rubber Hand Illusion protocol (Specific Aim 1). This thrust will ask how does the amount of embodiment vary among conventional prosthetic hands as well as probe the relationship between agency and embodiment. The device development project entails the design of multi-modal sensors in order to study full-hand embodiment (Specific Aim 2). The ability to measure and then elicit sensation on the passive surfaces of the hand (palm, ulnar border, and dorsal surface) has never been explored. Here, a multi-modal sensor which can detect proximity, contact, and force will be integrated into a commercially available prosthetic hand in order to provide detailed measurements across the palm, ulnar border, and dorsal surfaces in order to study embodiment in more depth. Finally, the characterization of embodiment using peripheral nerve stimulation will take place over a multiple subject factorial experiment which quantifies the effects of quantity and spatial parameters of the peripheral nerve stimulation on the embodiment of prosthetic hands (Specific Aim 3). This study asks what somatosensory percepts from the hand are most critical for embodiment by varying the parameters of the peripheral nerve stimulation (quantity and spatiality) and measuring the level of embodiment in each case.
This study is designed to evaluate the feasibility of The Adaptive Neural Systems Neural-Enabled Prosthetic Hand (ANS-NEPH) system.
Individuals with upper-limb amputation usually have intact nerves within the residual limb, and studies have demonstrated that electrical stimulation of those nerves can produce sensations that appear to emanate from the amputated limb. In this study, investigators will examine the sensations that are produced by electrical stimulation of these nerves at the location where they exit the spinal cord. Stimulation of the spinal cord is commonly used to treat intractable back and limb pain, and the procedure includes a test phase in which electrodes are temporarily placed under the skin near the spinal cord and removed at the end of testing. Similarly, in this study, electrodes will be placed near the spinal cord in the upper back and neck, and stimulation will be applied over the course of multiple testing sessions, lasting less than 30 days. The electrodes will be removed at the last day of testing. During each testing session, electrical stimulation will be applied through the electrodes and a series of tests will be performed to determine the types of sensations produced by stimulation. In addition to producing meaningful sensations with electrical stimulation, this study will also test the effect of stimulation on phantom limb sensations and phantom limb pain.
This study will examine whether tactile (touch) abilities at the lip are more acute in people with upper limb amputation compared with healthy normal volunteers. People with an amputated upper limb have an expanded brain representation of the lip that may correlate with heightened tactile spatial acuity. Normal volunteers will be recruited for this study. Candidates will be screened with physical and neurological examinations. (Amputee volunteers will be studied at the amputee clinic at the University of Tubingen, Germany.) Participants will sit comfortably in a chair, wearing a blindfold, during the following experiments: * Plastic domes with grooves are placed on parts of the lower lip on either side for a few seconds. The volunteer is then asked to identify the direction of the grooves relative to the long axis of the lip. * The participant's arm is placed in a cast and the index finger is immobilized. The same test done on the lip is repeated on the distal part of the index finger. Each part of the test lasts about 20 minutes, and the entire experiment takes about 2 hours.
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. The research team uses Functional Electrical Stimulation (FES), which involves applying small electric currents to the nerves. These signals are then transferred to the brain just like the information about the individual's intact hand used to be transferred to their brain. This study will test different placements for stimulation and determine which one(s) provide the individual with proprioceptive sensations. The investigators want to know what the participants feel and if the investigators can use proprioceptive sensation to give the participants information about limb movement and position.
The study is evaluating the performance of prosthesis control system, referred to as Phantom X, in able bodied individuals and individuals with upper limb amputation at the forearm level.
Liberating Technologies, Inc. (LTI) has developed a dexterous prosthetic fingertip that will be fit onto an i-Digits™ partial hand prosthesis and allow for an additional fine grasp. The device will interface with research participants' existing prostheses and use the same control strategy that is used for their everyday use. Each participant's prosthesis will be restored to their original configuration by the end of their testing period.
Upper limb amputation is a devastating injury that leaves many thousands of typically young and active individuals in the US to rely on artificial arms and hands to help restore their lost function. The investigators research is focused on helping these individuals to feel where their prosthetic limbs are moving without having to look at them by developing devices and approaches to provide sensory feedback of limb movement through the nerves that once served the missing limb.
The goal is to understand the critical factors associated with outcome acceptance following upper limb loss. The investigators aim to develop a unified theoretical model that describes the psychosocial experience of upper limb prosthesis use and predicts outcome acceptance following upper limb loss. The investigators will also examine experiences with prosthesis education, selection, and training as well as how psychological and social issues impact prosthesis use. In addition, the investigators will use the findings to develop a prototype decision tool to assist with matching persons to prostheses. Study findings will help providers, technology developers, and researchers better understand the complex experience of upper limb prosthesis use. This conceptual framework will enable clinicians and researchers to evaluate and predict patient outcomes following limb loss, and to design interventions that improve outcomes. The proposed study is a mixed methods (qualitative and quantitative) study using an observational design. The qualitative component of the study will involve data collection through telephone interviews with 42 participants and analyses using a grounded theory approach with constant comparison methods. The quantitative component involves administration of standardized measures quantifying constructs of the theoretical model in 120 participants and analyses to produce a structural equation model of outcome acceptance. Participants will include persons with unilateral acquired upper limb loss at the trans radial or trans humeral level who use currently available prosthetic devices. Up to 16 individuals will participate in a series of focus groups that will be conducted to provide feedback on the model generated from previous data.
The purpose of this study is to optimize the Defense Advanced Research Projects Agency's (DARPA) advanced upper limb prosthesis, the Modular Prosthetic Limb (MPL), by evaluating the performance, usability, and patient acceptance of the MPL in a clinical setting. This study will be a non-randomized limited clinical optimization study. The study will consist of two phases. Up to twenty-four upper extremity amputees will be recruited in order to ensure twelve subjects for participation in the study: 6 trans-humeral amputees and 6 trans-radial amputees. During Phase 1, subjects will be evaluated for their potential to operate the MPL using a virtual limb controlled by signals from surface electromyograms (sEMG). The first six trans-humeral amputee subjects and the first six trans-radial amputee subjects with a demonstrated proficiency controlling the MPL based on analytical performance metrics will enter Phase 2. During Phase 2, each subject will be fitted for the prosthesis with a custom socket. The user will then evaluate the prosthesis during twelve 1- hour or 1 and one half-hour sessions, working with an occupational therapist and research associates and completing both quantitative and qualitative assessments.
The focus of this study is to conduct a clinical study in individuals with transradial amputations to compare function using a 1-DOF or 2-DOF wrist. All prostheses will be attached to a single DOF Otto Bock hand and controlled using a pattern recognition system equivalent to the Coapt system. This study will enable the investigator to quantify the relative functional value of powered wrist flexion during both in-laboratory testing and home use. In addition, the investigators will address the effectiveness of different hand-wrist combinations to enhance patient-centered clinical decision making.
The purpose of this study is to identify the best treatment sequence and combination of acupuncture points for the treatment of phantom limb or residual limb pain in the traumatic/surgical amputee.