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Prosthesis With Sensations

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ClinicalTrials.gov Identifier: NCT03350061
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : July 20, 2018
Sponsor:
Collaborators:
Axonic
SensArs Neuroprosthetics Sarl
Institut für Mikrosystemtechnik (IMTEK), Albert-Ludwigs-Universität Freiburg
Ripple LLC
Össur hf
Information provided by (Responsible Party):
Francesco Petrini, SensArs Neuroprosthetics Sarl

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Amputation Phantom Limb Pain Sensory Deficit Device: SENSY Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Restoration of Sensations From the Lost Limb to Amputees for Fall Avoidance, Regular Walking, Phantom Limb Pain Diminishment and Embodiment of Prosthesis
Actual Study Start Date : November 12, 2017
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Arm Intervention/treatment
Experimental: SENSY benefit
Sensory 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.
Device: SENSY
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.




Primary Outcome Measures :
  1. Impact of SENSY on mobility [ Time Frame: within 3 months post implant ]
    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).

  2. Impact of SENSY on falls avoidance [ Time Frame: within 3 months post implant ]
    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).

  3. Impact of SENSY on metabolic consumption [ Time Frame: within 3 months post implant ]
    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).

  4. Incidence of all serious adverse events concerning SENSY [ Time Frame: within 3 months post implant ]
    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.


Secondary Outcome Measures :
  1. Impact of SENSY on phantom pain: neuropathic pain symptom inventory score [ Time Frame: within 3 months post implant ]
    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).

  2. Impact of SENSY on phantom pain: visual analog scale score [ Time Frame: within 3 months post implant ]
    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).

  3. Impact of SENSY on phantom pain before and after the implant of SENSY: NPSI score [ Time Frame: until up to 3 months post explant ]
    Average change in NPSI pain score among 1 day pre-implant, 1 day pre-explant, 1.5 and 3 months after the explant.

  4. Impact of SENSY on phantom pain before and after the implant of SENSY: VAS score [ Time Frame: until up to 3 months post explant ]
    Average change in VAS pain score among 1 day pre-implant, 1 day pre-explant, 1.5 and 3 months after the explant.

  5. Impact of SENSY on embodiment (perception of the prosthesis as part of the body): questionnaires [ Time Frame: within 3 months post implant ]
    Average change of embodiment (measured through questionnaires) after use of the prosthesis with and without intraneural stimulation.

  6. Impact of SENSY on embodiment (perception of the prosthesis as part of the body): proprioceptive drift [ Time Frame: within 3 months post implant ]
    Average change of embodiment (measured through proprioceptive drift) after use of the prosthesis with and without intraneural stimulation.

  7. Impact of SENSY on cognitive effort [ Time Frame: within 3 months post implant ]
    Average change of cortical burden (measured as electroencephalography (EEG) activity) during use of the prosthesis with and without intraneural stimulation.

  8. Impact of SENSY on cortical plasticity [ Time Frame: within 3 months post explant ]
    Average cortical reorganization measured through functional Magnetic Resonance Imaging between after the implant and after the explant.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350061


Contacts
Contact: Francesco M Petrini, PhD +38162296113 francesco.petrini86@gmail.com
Contact: Stanisa Raspopovic, PhD +381611733696 nesta.fale@gmail.com

Locations
Serbia
Clinical center of Serbia Recruiting
Belgrade, RS, Serbia, 11000
Contact: Aleksandar Lešić, Prof    +381113615537    alelesic@gmail.com   
Sponsors and Collaborators
Clinical Centre of Serbia
Axonic
SensArs Neuroprosthetics Sarl
Institut für Mikrosystemtechnik (IMTEK), Albert-Ludwigs-Universität Freiburg
Ripple LLC
Össur hf
Investigators
Study Director: Aleksandar Lešić, Prof Clinical center of Serbia

Responsible Party: Francesco Petrini, President, SensArs Neuroprosthetics Sarl
ClinicalTrials.gov Identifier: NCT03350061     History of Changes
Other Study ID Numbers: Osecaj Opet
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Pain
Postoperative Complications
Pathologic Processes
Signs and Symptoms