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Neural Prosthesis
Neural Enabled Prosthesis for Upper Limb Amputation
N/A
Recruiting
Led By Ranu Jung, Ph.D.
Research Sponsored by Ranu Jung PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 104 weeks - post-treatment
Awards & highlights
Study Summary
This trial will test a new kind of prosthetic hand that uses a neural interface.
Who is the study for?
This trial is for U.S. residents aged 18 or older who have had a unilateral left arm and hand amputation at least 9 months ago, can use a myoelectric arm, and have a functional opposite hand. Participants must be able to travel to the research site, not have limb loss from birth defects, no severe infections or chronic pain, not pregnant/nursing, and without cognitive impairments that affect compliance.Check my eligibility
What is being tested?
The study tests the Adaptive Neural Systems Neural-Enabled Prosthetic Hand (ANS-NEPH) system's feasibility for individuals with an upper limb amputation. It aims to see how well participants can control this advanced prosthesis which uses neural inputs.See study design
What are the potential side effects?
While specific side effects are not listed for this device trial, potential risks may include skin irritation from prosthetic materials, discomfort during use of the prosthesis, possible strain on remaining muscles and joints due to new usage patterns.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 104 weeks - post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 104 weeks - post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of the Neural Stimulation System
Secondary outcome measures
Clinical Assessment: Adaptive Neural Systems - Phantom Limb Telescoping Assessment (ANS-PLTA)
Clinical Assessment: The Southampton Hand Assessment Procedure (SHAP)
Clinical Surveys: 12-Item Short Form Survey (SF-12)
+9 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Neural Enabled ProsthesisExperimental Treatment1 Intervention
Neural Enabled Prosthesis Treatment Group
Find a Location
Who is running the clinical trial?
National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
89 Previous Clinical Trials
19,778 Total Patients Enrolled
1 Trials studying Prosthesis User
16 Patients Enrolled for Prosthesis User
United States Department of DefenseFED
861 Previous Clinical Trials
227,188 Total Patients Enrolled
4 Trials studying Prosthesis User
334 Patients Enrolled for Prosthesis User
Ranu Jung PhDLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able and willing to use a prosthetic arm that is controlled by muscle activity (determined by a prosthetist).You were born without a limb.You have reported being sensitive or allergic to materials that come from pigs.You are currently receiving diathermy therapy on your remaining limb.You have a history of mental health disorders or drug/alcohol addiction.You have trouble remembering things or have significant difficulty thinking clearly.You have ongoing and intense pain that lasts for a long time.You have difficulty seeing that could make it hard for you to use your hands during the study procedures.You have a history of long-term infections.You had a limb amputated nine months ago or longer.Your other hand (the one not affected by amputation) is fully functional.You have amputation on one arm below the elbow.You have a medical or mental condition that could put you at risk or make it difficult for you to feel sensations from nerve stimulation in your limb. This includes conditions like uncontrolled high blood pressure, heart or lung disease, active infection, and serious metabolic disorders.You have a history of frequent sores or blisters on the remaining part of your limb.You have a neurological condition that affects your ability to use your hand or limb.You have severe phantom limb pain that makes it difficult for you to do daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Neural Enabled Prosthesis
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment process for this trial still in progress?
"Affirmative. The details available on clinicaltrials.gov demonstrate that this medical trial is currently recruiting participants, having first been listed on December 14th 2017 and last modified on July 14th 2022. In total, 6 patients are to be enrolled across 2 sites."
Answered by AI
To what extent is the population being surveyed in this research study?
"Affirmative. Clinicaltrials.gov documents indicate that this study, which was first posted on December 14th 2017 is actively seeking participants for enrollment. A total of 6 patients are needed from 2 medical centres."
Answered by AI
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