Trial Outcomes & Findings for Virtual Neuroprosthesis: Restoring a Sense of Touch to Amputees (NCT NCT03581448)

NCT ID: NCT03581448

Last Updated: 2023-09-18

Results Overview

The percentage that grasped objects are successfully transported without slip or drop when controlled by amputees using an artificial hand.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2023-09-18

Participant Flow

Exclusion criteria preventing subjects from participating are an amputation wound that has not yet healed, the absence of a suitable length of residual limb for placement of haptic feedback controller and EMG sensors, presence of pain that prevents utilization of those experimental appliances and the use of psychoactive drugs that modifies baseline neural activity.

Participant milestones

Measure	Experimental: Nerve Growth During Prosthesis Control Determine the optimum conditions that promote sensory restoration in limb-absent people, with an adaptive haptic feedback control law that mimics the experience of neural plasticity. The intervention Sensory Restoration During Prosthesis Control will be used.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Virtual Neuroprosthesis: Restoring a Sense of Touch to Amputees

Baseline characteristics by cohort

Measure	Nerve Growth During Prosthesis Control n=21 Participants Determine the optimum conditions that promote sensory restoration in limb-absent people, with an adaptive haptic feedback control law that mimics the experience of neural plasticity. The intervention Sensory Restoration During Prosthesis Control will be used. Sensory Restoration During Prosthesis Control: Human subjects who use a robotic arm/hand interface will experience variable sensations of touch over time.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

The percentage that grasped objects are successfully transported without slip or drop when controlled by amputees using an artificial hand.

Outcome measures

Measure	Experimental: Nerve Growth During Prosthesis Control n=21 Participants Determine the optimum conditions that promote sensory restoration in limb-absent people, with an adaptive haptic feedback control law that mimics the experience of neural plasticity. The intervention Sensory Restoration During Prosthesis Control will be used.
Artificial Hand Grasp Performance Metrics	90.6 percentage of successful transportation Standard Deviation 14.0

SECONDARY outcome

Timeframe: 1 week

The length of neurite regeneration 1 week post-axotomy will be quantified. The dorsal root ganglia will be cultured in vitro in a multichannel microelectrode array. The neural culture will be electrically stimulated based on the touch sensations from the artificial hand that is used by amputees. The fingertip touch sensations will be biomimetically converted into pulses that resemble action potentials for the electrical stimulation. The length of neurite regeneration was quantified using NeuronJ to compare images at the beginning and endpoints of the study.

Outcome measures

Measure	Experimental: Nerve Growth During Prosthesis Control n=21 Participants Determine the optimum conditions that promote sensory restoration in limb-absent people, with an adaptive haptic feedback control law that mimics the experience of neural plasticity. The intervention Sensory Restoration During Prosthesis Control will be used.
Dorsal Root Ganglia Neurite Regeneration	2309 micrometer Standard Deviation 222

Adverse Events

Experimental: Nerve Growth During Prosthesis Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Erik Engeberg

Florida Atlantic University

Phone: 5612970530

Email: eengeberg@fau.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place