Prosthesis With Sensations
Primary Purpose
Amputation, Phantom Limb Pain, Sensory Deficit
Status
Completed
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
SENSY
Sponsored by
About this trial
This is an interventional treatment trial for Amputation
Eligibility 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
Sites / Locations
- Clinical center of Serbia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SENSY benefit
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
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).
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).
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.
Secondary Outcome Measures
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).
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).
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.
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.
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.
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.
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.
Impact of SENSY on cortical plasticity
Average cortical reorganization measured through functional Magnetic Resonance Imaging between after the implant and after the explant.
Full Information
NCT ID
NCT03350061
First Posted
November 12, 2017
Last Updated
July 14, 2020
Sponsor
Clinical Centre of Serbia
Collaborators
Axonic, SensArs Neuroprosthetics Sarl, Institut für Mikrosystemtechnik (IMTEK), Albert-Ludwigs-Universität Freiburg, Ripple LLC, Össur hf
1. Study Identification
Unique Protocol Identification Number
NCT03350061
Brief Title
Prosthesis With Sensations
Official Title
Restoration of Sensations From the Lost Limb to Amputees for Fall Avoidance, Regular Walking, Phantom Limb Pain Diminishment and Embodiment of Prosthesis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 12, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
July 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Centre of Serbia
Collaborators
Axonic, SensArs Neuroprosthetics Sarl, Institut für Mikrosystemtechnik (IMTEK), Albert-Ludwigs-Universität Freiburg, Ripple LLC, Össur hf
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation, Phantom Limb Pain, Sensory Deficit
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SENSY benefit
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SENSY
Intervention Description
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 Measure Information:
Title
Impact of SENSY on mobility
Description
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
Title
Impact of SENSY on falls avoidance
Description
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
Title
Impact of SENSY on metabolic consumption
Description
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
Title
Incidence of all serious adverse events concerning SENSY
Description
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
Secondary Outcome Measure Information:
Title
Impact of SENSY on phantom pain: neuropathic pain symptom inventory score
Description
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
Title
Impact of SENSY on phantom pain: visual analog scale score
Description
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
Title
Impact of SENSY on phantom pain before and after the implant of SENSY: NPSI score
Description
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
Title
Impact of SENSY on phantom pain before and after the implant of SENSY: VAS score
Description
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
Title
Impact of SENSY on embodiment (perception of the prosthesis as part of the body): questionnaires
Description
Average change of embodiment (measured through questionnaires) after use of the prosthesis with and without intraneural stimulation.
Time Frame
within 3 months post implant
Title
Impact of SENSY on embodiment (perception of the prosthesis as part of the body): proprioceptive drift
Description
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
Title
Impact of SENSY on cognitive effort
Description
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
Title
Impact of SENSY on cortical plasticity
Description
Average cortical reorganization measured through functional Magnetic Resonance Imaging between after the implant and after the explant.
Time Frame
within 3 months post explant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandar Lešić, Prof
Organizational Affiliation
Clinical center of Serbia
Official's Role
Study Director
Facility Information:
Facility Name
Clinical center of Serbia
City
Belgrade
State/Province
RS
ZIP/Postal Code
11000
Country
Serbia
12. IPD Sharing Statement
Citations:
PubMed Identifier
35461007
Citation
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.
Results Reference
derived
PubMed Identifier
33417885
Citation
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.
Results Reference
derived
PubMed Identifier
31501600
Citation
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.
Results Reference
derived
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Prosthesis With Sensations
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