An interventional study of SENSY in Amputation, Phantom Limb Pain and Sensory Deficit, sponsored by Clinical Centre of Serbia. Completed at 1 site in Serbia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-15.
Sponsored by Clinical Centre of Serbia · Not applicable, Interventional, and Treatment
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.
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.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's enrollment of 3 is below the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Clinical Centre of Serbia is the lead sponsor of 24 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
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).
Time frame: within 3 months post implant
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).
Time frame: within 3 months post implant
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).
Time frame: within 3 months post implant
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.
Time frame: within 3 months post implant
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).
Time frame: within 3 months post implant
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).
Time frame: within 3 months post implant
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.
Time frame: until up to 3 months post explant
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.
Time frame: until up to 3 months post explant
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.
Time frame: within 3 months post implant
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.
Time frame: within 3 months post implant
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.
Time frame: within 3 months post implant
Impact of SENSY on cortical plasticity
Average cortical reorganization measured through functional Magnetic Resonance Imaging between after the implant and after the explant.
Time frame: within 3 months post explant
Ran from Nov 2017 to primary completion in Aug 2018, 8 months.
Of 61 non-industry interventional studies with no phase under Phantom Limb, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 8 months is below that.
Counting every sponsor, half of 64 studies reached it within 34 months; a quarter within 13 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Clinical Centre of Serbia