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AmputationNCT03350061

Prosthesis With Sensations

A study testing SENSY in people with Amputation and Phantom Limb Pain, run by Clinical Centre of Serbia at 1 site in Serbia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Lower limb amputees suffer complete lack of sensory feedback of current available prostheses, which excludes the central nervous system from the correct sensory-motor integration. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Amputation, Phantom Limb Pain, Sensory Deficit
What is being tested?
SENSY
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteSerbia
Study dates
12 Nov 2017to 14 Jul 2020
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Uni-lateral transfemoral amputation above the knee level
  • Other treatments for phantom limb pain should have been tried with poor results
  • The subject should experience phantom limb pain at a level of 6 or higher measured on on a visual analog scale (VAS) ranging from 0-10
  • Phantom limb pain should be experienced at least once a week
  • The subject should be in a chronic and stable phase, and the stump should have healed
  • The subject should otherwise be healthy and able to carry out the experiment
  • If pain medication is used it will be acceptable that the person continues to use the medication

Who cannot join

  • Cognitive impairment
  • Pregnancy
  • Prior or current psychological diseases such as borderline, schizophrenia, depression or maniodepression
  • Acquired brain injury with residual impairment
  • Prior neurological or musculoskeletal diseases
  • History of or active substance abuse disorder
Show all 10Show fewer
  • Excessive sensitivity to electrical stimulation with surface electrodes
  • Persons with fear for electrical stimulation, pain cannot participate
  • Persons that are hypersensitive to electrical stimulation and experience the stimulation as unpleasant cannot participate
  • Since the protocol includes MRI scanning of the brain, persons that may feel claustrophobic cannot participate

Trial locations and contacts

1 site in 1 country.

Serbia1 site

  • Clinical center of Serbia

    Belgrade, RS, 11000

Other trials in Serbia

About this study

Official title: Restoration of Sensations From the Lost Limb to Amputees for Fall Avoidance, Regular Walking, Phantom Limb Pain Diminishment and Embodiment of Prosthesis

Lower limb amputees suffer complete lack of sensory feedback of current available prostheses, which excludes the central nervous system from the correct sensory-motor integration. It causes serious problems as: falls due to unexpected perturbations, asymmetric walking, low mobility, higher power consumption, feeling the prosthesis as a foreign body, high cognitive burden, and phantom limb pain occurrence.

Investigators will provide amputees with a prosthesis restoring sensory feedback and will assess its benefits on the users.

Read the detailed description

The clinical investigation described here aims at evaluating the benefit of a lower limb prosthesis providing sensory feedback (bidirectional prosthesis), in selected transfemoral amputees. The device is constituted by i) Rheo Knee XC, Pro Flex foot and customized socket/liner structure from OSSUR. Rheo Knee embedded already an encoder coupled with a Bluetooth unit, which is used to make communication with devices external to the knee itself; ii) nerve stimulating system constituted by implantable intraneural electrodes from IMTEK, iii) an external neurostimulator from AXONIC, and iv) sensorized sole from SensArs Neuroprosthetics to apply under the prosthetic foot and driving the stimulating system. The readout of the sensorized insole are transmitted via Bluetooth, together with the encoder readout, to an external controller, which transduces it in parameters of stimulation. These parameters are sent to the stimulator, which injects current into the intraneural electrodes. As final result, the subject perceives sensory feedback from the prosthesis when using it.

Investigators call SENSY the sensory feedback restoration system. The subjects will use the prosthesis with and without sensory feedback to execute walking tasks. The average change of kinematics (including falls), metabolic cost, embodiment, and cognitive burden (EEG) when intraneural stimulation is provided will be compared to the case in which there is no sensory feedback. Standard clinical tests (as PEQ and CB\&MS) will be executed with and without sensory feedback. Also, when the subjects will report attacks of phantom pain, they will undergo a 10-minutes-stimulation session. Only stimulation without prosthesis is used in this intervention.

Finally, imaging of the cortical activity will be executed through functional magnetic resonance imaging (fMRI). This procedure will be only observational since no prosthesis or sensory feedback will be used by the subjects.

Being tested
SENSY
Medical subject headings
Phantom Limb

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SENSYDevice

    The sensory feedback will be delivered by SENSY with or without the leg prosthesis. Benefits connected to the stimulation of sensory nerves will be assessed.

Study groups in NCT03350061
Study groupRoleWhat they receive
SENSY benefitExperimentalSensory feedback elicited by intraneural stimulation will be provided by SENSY with and without the leg prosthesis to improve walking ability, increase embodiment, and reduce metabolic cost, cognitive load and phantom pain.
Receives: Device: SENSY

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Impact of SENSY on mobility

    Demonstration of statistically relevant increase of kinematic walking speed (distance/minute) during the execution of tests involving the use of the prosthesis with intraneural stimulation compared to without the stimulation (e.g. climbing and descending stairs, tandem walking, walking on an outdoor surface).

    Measured: within 3 months post implant

  2. Impact of SENSY on falls avoidance

    Demonstration of statistically relevant decrease of falls during the execution of tests involving the use of the prosthesis with intraneural stimulation compared to without the stimulation (e.g. walking on a surface with obstacles).

    Measured: within 3 months post implant

  3. Impact of SENSY on metabolic consumption

    Demonstration of statistically relevant decrease of metabolic cost during the execution of tests involving the use of the prosthesis with intraneural stimulation compared to without the stimulation (e.g. walking on the treadmill and walking on an outdoor surface). Metabolic cost is measured as volume of oxygen (VO2) consumption (mLO2/kg/meter).

    Measured: within 3 months post implant

  4. Incidence of all serious adverse events concerning SENSY

    Incidence of all serious adverse events, including Serious Adverse Events, Serious Adverse Device Events, and Unanticipated (Serious) Adverse Device Events from the time of consent through 3 months post implant.

    Measured: within 3 months post implant

Secondary outcomes (8)

  1. Impact of SENSY on phantom pain: neuropathic pain symptom inventory score

    Demonstration of statistically relevant reduction in neuropathic pain symptom inventory (NPSI) pain score (0-100) from pre-treatment to post-treatment (10-minutes stimulation session is the treatment).

    Measured: within 3 months post implant

  2. Impact of SENSY on phantom pain: visual analog scale score

    Demonstration of statistically relevant reduction in visual analog scale (VAS) pain score (0-10) from pre-treatment to post-treatment (10-minutes stimulation session is the treatment).

    Measured: within 3 months post implant

  3. Impact of SENSY on phantom pain before and after the implant of SENSY: NPSI score

    Average change in NPSI pain score among 1 day pre-implant, 1 day pre-explant, 1.5 and 3 months after the explant.

    Measured: until up to 3 months post explant

  4. Impact of SENSY on phantom pain before and after the implant of SENSY: VAS score

    Average change in VAS pain score among 1 day pre-implant, 1 day pre-explant, 1.5 and 3 months after the explant.

    Measured: until up to 3 months post explant

  5. Impact of SENSY on embodiment (perception of the prosthesis as part of the body): questionnaires

    Average change of embodiment (measured through questionnaires) after use of the prosthesis with and without intraneural stimulation.

    Measured: within 3 months post implant

  6. Impact of SENSY on embodiment (perception of the prosthesis as part of the body): proprioceptive drift

    Average change of embodiment (measured through proprioceptive drift) after use of the prosthesis with and without intraneural stimulation.

    Measured: within 3 months post implant

  7. Impact of SENSY on cognitive effort

    Average change of cortical burden (measured as electroencephalography (EEG) activity) during use of the prosthesis with and without intraneural stimulation.

    Measured: within 3 months post implant

  8. Impact of SENSY on cortical plasticity

    Average cortical reorganization measured through functional Magnetic Resonance Imaging between after the implant and after the explant.

    Measured: within 3 months post explant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2017
  2. Study start12 Nov 2017
  3. Primary completion1 Aug 2018
  4. Study completion14 Jul 2020

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03350061
Sponsor's protocol ID
Osecaj Opet
Status last verified
Jul 2020
First submitted
12 Nov 2017
Last updated
15 Jul 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Valle G, Katic Secerovic N, Eggemann D, Gorskii O, Pavlova N, Petrini FM, Cvancara P, Stieglitz T, Musienko P, Bumbasirevic M, Raspopovic S. Biomimetic computer-to-brain communication enhancing naturalistic touch sensations via peripheral nerve stimulation. Nat Commun. 2024 Feb 20;15(1):1151. doi: 10.1038/s41467-024-45190-6.

    PubMed 38378671

  • Petrusic I, Valle G, Dakovic M, Damjanovic D, Bumbasirevic M, Raspopovic S. Plastic changes in the brain after a neuro-prosthetic leg use. Clin Neurophysiol. 2022 Jun;138:186-188. doi: 10.1016/j.clinph.2022.04.001. Epub 2022 Apr 9. No abstract available.

    PubMed 35461007

  • Preatoni G, Valle G, Petrini FM, Raspopovic S. Lightening the Perceived Prosthesis Weight with Neural Embodiment Promoted by Sensory Feedback. Curr Biol. 2021 Mar 8;31(5):1065-1071.e4. doi: 10.1016/j.cub.2020.11.069. Epub 2021 Jan 7.

    PubMed 33417885

  • Petrini FM, Bumbasirevic M, Valle G, Ilic V, Mijovic P, Cvancara P, Barberi F, Katic N, Bortolotti D, Andreu D, Lechler K, Lesic A, Mazic S, Mijovic B, Guiraud D, Stieglitz T, Alexandersson A, Micera S, Raspopovic S. Sensory feedback restoration in leg amputees improves walking speed, metabolic cost and phantom pain. Nat Med. 2019 Sep;25(9):1356-1363. doi: 10.1038/s41591-019-0567-3. Epub 2019 Sep 9.

    PubMed 31501600

Questions about this trial

What is this clinical trial studying?

A study testing SENSY in people with Amputation and Phantom Limb Pain, run by Clinical Centre of Serbia at 1 site in Serbia.

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 7 inclusion and 10 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 15 Jul 2020. 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 Serbia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Impact of SENSY on mobility (time frame: within 3 months post implant). The study lists 4 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 NCT03350061, which also lists 4 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 15 Jul 2020.

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