AmputationNCT03581448
Virtual Neuroprosthesis: Restoring a Sense of Touch to Amputees
A study of Amputation, run by Florida Atlantic University at 1 site in United States.
Trial summary
The overall goal of this project is to develop a virtual neuroprosthesis in which a facsimile of a neural implant is externalized and housed in a well-controlled microfluidic chamber, thereby abating the intrinsic limitations of highly invasive studies with neural implants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2017to 26 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No neurological impairment of tactile sensation.
Who cannot join
- Younger than 18 or older than 65
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Atlantic University
Boca Raton, Florida, 33431
About this study
Official title: Virtual Neuroprosthesis: Restoring Autonomy to People Suffering From Neurotrauma
The overall goal of this project is to develop a virtual neuroprosthesis in which a facsimile of a neural implant is externalized and housed in a well-controlled microfluidic chamber, thereby abating the intrinsic limitations of highly invasive studies with neural implants. Able-bodied and upper limb amputee subjects will be recruited to control a dexterous artificial hand and arm with electromyogram signals while electroencephalogram (EEG) signals are simultaneously measured. Robotic grip force measurements will be biomimetically converted into electrical pulses similar to those found in the peripheral nervous system to catalyze in vitro nerve regeneration after neurotrauma. The synergistic contributions of this multidisciplinary project will lead to a transformative understanding of the symbiotic interaction of neural plasticity within human-robotic systems. Currently, there is no systematic understanding of how tactile feedback signals can contribute to the neural regeneration of afferent neural pathways to restore somatosensation and improve motor function in amputees fitted with neuroprosthetic limbs. Tackling this problem will be a significant breakthrough for the important field of neuroprosthetics.
Read the detailed description
Over one week, neurobehavioral processes will be examined in people controlling a robotic arm and hand to perform simple motor tasks (e.g. fragile object transportation), while a virtual peripheral nerve regeneration protocol provides users with biologically-realistic, idiosyncratic parameters for the restoration of haptic sensation (in double-blind fashion, the cellular neurophysiologists characterizing neural regeneration with microscopy are unaware of subjects' name and condition; and the human-subject experimenters are unaware of the haptic feedback parameter that will be used in the experiment each day, which is entered by the neurophysiologist in a black-box section of the software in the case of microscopic evaluation of nerve regeneration (early part of the project), or which is automatically input by the system in the case of real time impedimetric measurements (later part of the project)).
The main experimental factors are 'haptic feedback', with three modalities: full, partial (nerve-regeneration dependent) and null; and to challenge human control strategy and impose demand on haptic information, the 'transported object weight' (heavy, medium and lightweight).
Recording techniques: Subjects' electroencephalography (EEG), electromyography (EMG) and behavioral performance.
- Conditions
- Amputation
- Being tested
- Sensory Restoration During Prosthesis Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Restoration During Prosthesis ControlBehavioural
Human subjects who use a robotic arm/hand interface will experience variable sensations of touch over time.
| Study group | Role | What they receive |
|---|---|---|
| Nerve Growth During Prosthesis Control | Experimental | 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. Receives: Behavioral: Sensory Restoration During Prosthesis Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Artificial Hand Grasp Performance Metrics
The percentage that grasped objects are successfully transported without slip or drop when controlled by amputees using an artificial hand.
Measured: 1 week
Secondary outcomes (1)
Dorsal Root Ganglia Neurite Regeneration
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start15 Oct 2017
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study falls under device feasibility: An intervention of a device product is being evaluated in a small clinical trial to determine the feasibility of the product; or a clinical trial to test a prototype device for feasibility and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Atlantic University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Erik Engeberg, Ph.D., Principal investigator, Florida Atlantic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581448
- Sponsor's protocol ID
- FloridaAU
- Other IDs
- R01EB025819
- Status last verified
- Sep 2023
- First submitted
- 13 Jun 2018
- Last updated
- 18 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Gender, ethnicity (if voluntarily disclosed), and nature of upper-limb absence (If applicable) are recorded. This information is reported in corresponding journal and conference publications.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Neuroprosthesis: Restoring Autonomy to People Suffering From Neurotrauma
- ClinicalTrials.gov ID
- NCT03581448
- Acronym / sponsor ID
- FloridaAU
- Conditions
- Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Florida Atlantic UniversityUniversity, hospital or other
- Collaborators
- University of Utah, National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Posted 18 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this project is to develop a virtual neuroprosthesis in which a facsimile of a neural implant is externalized and housed in a well-controlled microfluidic chamber, thereby abating the intrinsic limitations of highly invasive studies with neural implants. Able-bodied and upper limb amputee subjects will be recruited to control a dexterous artificial hand and arm with electromyogram signals while electroencephalogram (EEG) signals are simultaneously measured. Robotic grip force measurements will be biomimetically converted into electrical pulses similar to those found in the peripheral nervous system to catalyze in vitro nerve regeneration after neurotrauma. The synergistic contributions of this multidisciplinary project will lead to a transformative understanding of the symbiotic interaction of neural plasticity within human-robotic systems. Currently, there is no systematic understanding of how tactile feedback signals can contribute to the neural regeneration of afferent neural pathways to restore somatosensation and improve motor function in amputees fitted with neuroprosthetic limbs. Tackling this problem will be a significant breakthrough for the important field of neuroprosthetics.
Detailed description
Over one week, neurobehavioral processes will be examined in people controlling a robotic arm and hand to perform simple motor tasks (e.g. fragile object transportation), while a virtual peripheral nerve regeneration protocol provides users with biologically-realistic, idiosyncratic parameters for the restoration of haptic sensation (in double-blind fashion, the cellular neurophysiologists characterizing neural regeneration with microscopy are unaware of subjects' name and condition; and the human-subject experimenters are unaware of the haptic feedback parameter that will be used in the experiment each day, which is entered by the neurophysiologist in a black-box section of the software in the case of microscopic evaluation of nerve regeneration (early part of the project), or which is automatically input by the system in the case of real time impedimetric measurements (later part of the project)).
The main experimental factors are 'haptic feedback', with three modalities: full, partial (nerve-regeneration dependent) and null; and to challenge human control strategy and impose demand on haptic information, the 'transported object weight' (heavy, medium and lightweight).
Recording techniques: Subjects' electroencephalography (EEG), electromyography (EMG) and behavioral performance.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study falls under device feasibility: An intervention of a device product is being evaluated in a small clinical trial to determine the feasibility of the product; or a clinical trial to test a prototype device for feasibility and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Nerve Growth During Prosthesis Control | Experimental | Behavioral: Sensory Restoration During Prosthesis ControlDetermine 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No neurological impairment of tactile sensation.
Key exclusion criteria (1 listed)
- Younger than 18 or older than 65
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory Restoration During Prosthesis ControlHuman subjects who use a robotic arm/hand interface will experience variable sensations of touch over time. | Behavioural | Nerve Growth During Prosthesis Control |
Primary outcome
Artificial Hand Grasp Performance Metrics
Time frame: 1 week
The percentage that grasped objects are successfully transported without slip or drop when controlled by amputees using an artificial hand.
1 secondary outcome
Dorsal Root Ganglia Neurite Regeneration
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Gender, ethnicity (if voluntarily disclosed), and nature of upper-limb absence (If applicable) are recorded. This information is reported in corresponding journal and conference publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Engeberg, Ph.D. principal investigator
Florida Atlantic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Amputation, run by Florida Atlantic University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Artificial Hand Grasp Performance Metrics (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.