Feasibility of Neural Feedback for Lower Limb Amputees

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-05

Study Completion Date

2027-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Amputation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Stimulating nerve electrodes and intramuscular recording electrodes

Intervention Type DEVICE

See Arm Description

Interventions

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Stimulating nerve electrodes and intramuscular recording electrodes

See Arm Description

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults age 18 or greater
* Chronic, medically stable ( \> 3 months) unilateral trans-tibial or trans-femoral amputation at the time of implant surgery.
* 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 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 to a degree that would preclude surgery
* 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
* Severe neurological conditions that significantly impair balance or mobility to an extent that independent ambulation is impossible without assistance ( as determined by a healthcare provider)
* Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
* Poor surgical candidate
* Psychiatric or cognitive conditions that could affect cooperation or understanding of instructions and willingness to undergo psychological evaluation, if recommended by study surgeons or investigators.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No