Sensorized Hand ProsthesisNEBIASNCT02848846
NEurocontrolled BIdirectional Artificial Upper Limb and Hand prosthesiS
A study testing Robotic Hand in people with Sensorized Hand Prosthesis, run by Paolo Maria Rossini at 1 site in Italy.
Trial summary
The NEBIAS ("NEurocontrolled BIdirectional Artificial upper limb and hand prosthesiS") proposal aims at developing and clinically evaluating (in selected amputees) a neuro-controlled upper limb prosthesis intuitively controlled and felt by the amputee as the natural one. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorized Hand Prosthesis
- What is being tested?
- Robotic Hand
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult man or woman >18 yrs and < 71 yrs.
- Transradial amputation or Congenital Hand Hypoplasia
- Amputation in the chronic stable phase
- Good functionality of muscles of the stump
- Absence of severe stump pain (VAS<3)
Who cannot join
- Cognitive impairment
- Current or prior psychological impairments: Major personality disturbance (i.e. borderline, antisocial), Major depression, Bipolar I
- Pregnancy
- History of or active substance abuse disorder
- Acquired brain injury with residual impairment
- Intellectual Disability (IQ < 70)
Show all 12Show fewer
- Prior neurological or musculo-skeletal disease
- Current or prior dermatological conditions
- Excessive sensitivity to electrical stimulation (people afraid of electrical stimulation or pain)
- Persons with other diseases that may affect the function of the nervous system. (Diabetes, HIV, Renal Failure)
- Persons with pacemakers
- People affected by autoimmune and chronic infective diseases in treatment with immunosuppressive drugs
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Agostino Gemelli
Rome, Lazio, 00168
Paolo M Rossini, Full Professor, 00390635504435, paolomaria.rossini@gmail.com
About this study
The NEBIAS ("NEurocontrolled BIdirectional Artificial upper limb and hand prosthesiS") proposal aims at developing and clinically evaluating (in selected amputees) a neuro-controlled upper limb prosthesis intuitively controlled and felt by the amputee as the natural one. This will be possible by means of a novel neural interface able to provide a stable and very selective connection with the nervous system. This goal will be achieved by combining microtechnology and material science and will allow, on one side, recording of the motor-related signals governing the actions of the amputated hand/arm for the motion control of a mechanical prosthesis, and on the other providing sensory feedback from tactile and kinesthetic sensors through neuromorphic stimulation of the adequate afferent pathway within the residual limb. The NEBIAS proposal is also aimed at finding out the 'language' intrinsically linking central nervous system with peripheral nerve signals in order to govern simple and complex hand/fingers movements. To reach this goal, a variety of techniques exploring brain and nerve functions will be assembled and integrated; this includes the analysis of electromagnetic brain and nerve signals, as well as of movement-related changes in brain's blood flow/metabolism.
- Conditions
- Sensorized Hand Prosthesis
- Being tested
- Robotic Hand
- Keywords
- Amputees
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic HandDevice
The patients will use the robotic hand for a period of one year that will be divided in 3 different phases. The first phase is the intensive phase where the patient will use the robotic hand from Monday to Friday all days. This phase will last 6 weeks. The second phase is the semi-intensive where the patient will use the robotic hand only two days per week. This phase will last 6 weeks. The third phase is the monitoring where the patient will use the robotic hand only one day per week until the end of the trial.
During this phases the patient will perform different task requiring the use of the robotic hand.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Hand | Experimental | The two patient enrolled will perform the task requiring the use of the robotic hand. Receives: Device: Robotic Hand |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance of the robotic hand
Different level of pressure (percentage of success);
Measured: 1 year
performance of the robotic hand
Virtual egg test (percentage of success);
Measured: 1 year
performance of the robotic hand
Pick and Lift (percentage of success);
Measured: 1 year
performance of the robotic hand
Texture recognition (percentage of success);
Measured: 1 year
performance of the robotic hand
Shape recognition (percentage of success);
Measured: 1 year
performance of the robotic hand
Compliance recognition (percentage of success)
Measured: 1 year
Secondary outcomes (2)
Cortical map changes
Primary motor area (change of dimension and shape);
Measured: 1 year
Cortical map changes
Primary somatosensory area (change of dimension and shape);
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sensorized Hand ProsthesisStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paolo Maria Rossini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paolo Maria Rossini, Catholic University of the Sacred Heart
- Investigators
- paolo m rossini, professor, Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848846
- Sponsor's protocol ID
- FP7- ICT-2013.9.6
- Acronym
- NEBIAS
- Status last verified
- Jul 2016
- First submitted
- 23 Jun 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
Publications
Cracchiolo M, Panarese A, Valle G, Strauss I, Granata G, Iorio RD, Stieglitz T, Rossini PM, Mazzoni A, Micera S. Computational approaches to decode grasping force and velocity level in upper-limb amputee from intraneural peripheral signals. J Neural Eng. 2021 Apr 6;18(5). doi: 10.1088/1741-2552/abef3a.
PubMed 33725672Valle G, D'Anna E, Strauss I, Clemente F, Granata G, Di Iorio R, Controzzi M, Stieglitz T, Rossini PM, Petrini FM, Micera S. Hand Control With Invasive Feedback Is Not Impaired by Increased Cognitive Load. Front Bioeng Biotechnol. 2020 Apr 3;8:287. doi: 10.3389/fbioe.2020.00287. eCollection 2020.
PubMed 32318562
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEurocontrolled BIdirectional Artificial Upper Limb and Hand prosthesiS
- ClinicalTrials.gov ID
- NCT02848846
- Acronym / sponsor ID
- NEBIAS / FP7- ICT-2013.9.6
- Conditions
- Sensorized Hand Prosthesis
- Keywords
- Amputees
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Paolo Maria RossiniUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The NEBIAS ("NEurocontrolled BIdirectional Artificial upper limb and hand prosthesiS") proposal aims at developing and clinically evaluating (in selected amputees) a neuro-controlled upper limb prosthesis intuitively controlled and felt by the amputee as the natural one. This will be possible by means of a novel neural interface able to provide a stable and very selective connection with the nervous system. This goal will be achieved by combining microtechnology and material science and will allow, on one side, recording of the motor-related signals governing the actions of the amputated hand/arm for the motion control of a mechanical prosthesis, and on the other providing sensory feedback from tactile and kinesthetic sensors through neuromorphic stimulation of the adequate afferent pathway within the residual limb. The NEBIAS proposal is also aimed at finding out the 'language' intrinsically linking central nervous system with peripheral nerve signals in order to govern simple and complex hand/fingers movements. To reach this goal, a variety of techniques exploring brain and nerve functions will be assembled and integrated; this includes the analysis of electromagnetic brain and nerve signals, as well as of movement-related changes in brain's blood flow/metabolism.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Hand | Experimental | Device: Robotic HandThe two patient enrolled will perform the task requiring the use of the robotic hand. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult man or woman >18 yrs and < 71 yrs.
- Transradial amputation or Congenital Hand Hypoplasia
- Amputation in the chronic stable phase
- Good functionality of muscles of the stump
- Absence of severe stump pain (VAS<3)
Key exclusion criteria (12 listed)
- Cognitive impairment
- Current or prior psychological impairments: Major personality disturbance (i.e. borderline, antisocial), Major depression, Bipolar I
- Pregnancy
- History of or active substance abuse disorder
- Acquired brain injury with residual impairment
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 |
|---|---|---|
| Robotic HandThe patients will use the robotic hand for a period of one year that will be divided in 3 different phases. The first phase is the intensive phase where the patient will use the robotic hand from Monday to Friday all days. This phase will last 6 weeks. The second phase is the semi-intensive where the patient will use the robotic hand only two days per week. This phase will last 6 weeks. The third phase is the monitoring where the patient will use the robotic hand only one day per week until the end of the trial. During this phases the patient will perform different task requiring the use of the robotic hand. | Device | Robotic Hand |
Primary outcome
performance of the robotic hand
Time frame: 1 year
Different level of pressure (percentage of success);
performance of the robotic hand
Time frame: 1 year
Virtual egg test (percentage of success);
performance of the robotic hand
Time frame: 1 year
Pick and Lift (percentage of success);
performance of the robotic hand
Time frame: 1 year
Texture recognition (percentage of success);
performance of the robotic hand
Time frame: 1 year
Shape recognition (percentage of success);
performance of the robotic hand
Time frame: 1 year
Compliance recognition (percentage of success)
2 secondary outcomes
Cortical map changes
Time frame: 1 year
Cortical map changes
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Derived from this study: PubMed 33725672Cracchiolo M, Panarese A, Valle G, Strauss I, Granata G, Iorio RD, Stieglitz T, Rossini PM, Mazzoni A, Micera S. Computational approaches to decode grasping force and velocity level in upper-limb amputee from intraneural peripheral signals. J Neural Eng. 2021 Apr 6;18(5). doi: 10.1088/1741-2552/abef3a.
- Derived from this study: PubMed 32318562Valle G, D'Anna E, Strauss I, Clemente F, Granata G, Di Iorio R, Controzzi M, Stieglitz T, Rossini PM, Petrini FM, Micera S. Hand Control With Invasive Feedback Is Not Impaired by Increased Cognitive Load. Front Bioeng Biotechnol. 2020 Apr 3;8:287. doi: 10.3389/fbioe.2020.00287. eCollection 2020.
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.
paolo m rossini, professor principal investigator
Catholic University of the Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Hand in people with Sensorized Hand Prosthesis, run by Paolo Maria Rossini at 1 site in Italy.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Jul 2016. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Maria M Rossini, Professor (00390635504435, paolomaria.rossini@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
performance of the robotic hand (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02848846, which also lists 2 linked publications.
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 29 Jul 2016; AzTrials last refreshed its copy on 30 Oct 2026.