- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03409133
Feasibility of Sensory Feedback for Lower Limb Amputees
The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with lower limb loss, including above and below knee amputees. The approach involves delivering small electrical currents directly to remaining nerves via implanted stimulating electrodes. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how information about the foot and lower limb used to be transferred to your brain prior to the amputation.
Individuals also have the option to have recording electrodes implanted within muscles of the lower limb(s) in an attempt to develop a motor controller that would enable the user to have intuitive control of a robotic prosthetic leg.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Electrodes are surgically implanted on one to four nerves of the residual limb. An external wearable device controls the delivery of electrical pulses to the implanted system. The participant will be asked to verbally describe the perceived sensations and highlight their locations on a drawing of a foot presented to them on an electronic screen. An instrumented prosthesis will be developed such that perceived sensations would correspond to prosthesis interactions with the floor. This instrumented prosthesis, also known as a sensory neuroprosthesis, will be worn while the participant is engaging in various functional tasks, such as standing, walking, or climbing stairs, or with visual or mental distractions.
Intramuscular recording electrodes can be implanted in the lower limb(s) and/or hip muscles in order to obtain electromyography (EMG) signals. The EMG recordings from the residual muscles will be used to develop an algorithm which can operate an advanced robotic prosthesis in which the movement of the joint(s) could be controlled.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aarika Sheehan, PT, DPT
- Phone Number: 65832 216-791-3800
- Email: Aarika.Sheehan@va.gov
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Recruiting
- Louis Stokes VA Medical Center
-
Principal Investigator:
- Ronald Triolo, PhD
-
Contact:
- Aarika Sheehan, PT, DPT
- Phone Number: 65832 216-791-3800
- Email: Aarika.Sheehan@va.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults age 18 or greater
- Chronic, medically stable ( > 3 months) unilateral trans-tibial or trans-femoral amputation
- Potential user of trans-tibial or trans-femoral prostheses for standing or walking
- Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials (SEP) and the like
- Good skin integrity and personal hygiene
- Absence of autoimmune deficiencies, seizure disorders or cardiac abnormalities contraindicating stimulation
- Sufficient social support and personal ability to tolerate study procedures and comply with follow-up schedule
Exclusion Criteria:
- Uncontrolled diabetes with HbA1c greater than or equal to 69 mmol/mol (8.5%).
- Significant vascular disease
- Chronic skin ulcerations
- Significant history of poor wound healing
- Significant history of uncontrolled infections
- Active infection
- Significant pain in the residual or phantom limb
- Pregnancy
- Inability to speak English
- Expectation that MRI will be required at any point for the duration of study or while percutaneous leads are in place
- Arthritis in the area of implant
- History of vestibular or movement disorders that would compromise balance or walking
- Class II or III obesity (Body Mass Index > 35)
- Poor surgical candidate
- Uncontrolled depression, psychoses or cognitive impairments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stimulating nerve electrodes & intramuscular recording electrodes
Fifteen subjects with lower limb amputation will have multi-contact stimulating nerve cuff electrodes implanted around the nerves in their residual limb. These electrodes will be connected to temporary percutaneous leads. During experimental testing, a small amount of electrical current will be delivered to the nerves through multi-contact nerve cuff electrodes. Participants also have the option to have recording electrodes implanted within muscles in their lower limb(s). These muscles are associated with prosthetic movement, and recordings from these muscles will be used to develop a controller for a robotic myoelectric prosthesis. |
See Arm Description
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stimulation Thresholds
Time Frame: 9 months post implant
|
Quantify the minimum stimulation required to evoke electrically induced sensations on the phantom limb.
|
9 months post implant
|
Functional Gait Assessment (FGA)
Time Frame: 1 year post implant
|
The Functional Gait Assessment is a 10 task test that measures postural stability.
Each task is scored from 0 -3 with 0 indicating severe impairment in the task and 3 indicating normal ambulation.
The scores are combined to give a total score.
The maximum score is 30.
A higher score indicates a better outcome.
|
1 year post implant
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ronald Triolo, PhD, Louis Stokes VA Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 15046-H27
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Amputation
-
Liberating Technologies, Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedAmputation | Prosthesis User | Amputation; Traumatic, Hand | Amputation, CongenitalUnited States
-
Boninger, Michael, MDNational Institute of Neurological Disorders and Stroke (NINDS); Ripple Therapeutics...RecruitingAmputation | Amputation; Traumatic, HandUnited States
-
University of MichiganActive, not recruitingAmputation | Amputation; Traumatic, Leg, LowerUnited States
-
Shirley Ryan AbilityLabUnited States Department of DefenseCompletedAmputation | Amputation; Traumatic, Arm, UpperUnited States
-
Shirley Ryan AbilityLabEunice Kennedy Shriver National Institute of Child Health and Human Development...Active, not recruitingAmputation | Amputation; Traumatic, Limb | Upper Limb Amputation at the Hand | Upper Limb Amputation at the WristUnited States
-
Medipol UniversityRecruitingEvaluation of Functionality of Amputees According to the Medicare Functional K Classification SystemAmputation | Amputation; Traumatic, Leg, LowerTurkey
-
Fondazione Don Carlo Gnocchi OnlusCompletedAmputation | Amputation; Traumatic, Leg, LowerItaly
-
Fondazione Don Carlo Gnocchi OnlusCompletedAmputation | Amputation; Traumatic, Leg, LowerItaly
-
Hacettepe UniversityCompleted
-
Liberating Technologies, Inc.Vivonics, Inc.CompletedLower Limb Amputation Below Knee (Injury) | Amputation | Prosthesis User | Amputation; Traumatic, Leg, Lower | Limb; Absence, Congenital, Lower | Amputation StumpUnited States
Clinical Trials on Stimulating nerve electrodes and intramuscular recording electrodes
-
University of MichiganUnited States Department of DefenseRecruitingAmputation | Prostheses and ImplantsUnited States
-
Synapse BiomedicalJohns Hopkins University; Stanford University; University Hospitals Cleveland...UnknownAmyotrophic Lateral Sclerosis (ALS)United States, France
-
US Department of Veterans AffairsCompleted
-
US Department of Veterans AffairsCompleted
-
Mayo ClinicCompleted
-
University College, LondonNational Institutes of Health (NIH)Not yet recruitingEpilepsy | Vagus Nerve Diseases | Vagus Nerve Autonomic Disorder
-
Centre Hospitalier St AnneAssistance Publique - Hôpitaux de ParisRecruitingPsychotic Disorders | Schizophrenia | Autism Spectrum Disorder | Major Depressive DisorderFrance
-
Seoul National University HospitalCompletedCardiovascular Diseases | Cardiac ArrhythmiaKorea, Republic of
-
Chinese PLA General HospitalNot yet recruitingStroke | Hemiplegia | Stroke Sequelae | Deep Brain Stimulation | Vagus Nerve Stimulation | Motor RecoveryChina
-
VA Office of Research and DevelopmentRecruitingDiabetic Peripheral Neuropathy | Lower Extremity AmputeeUnited States