Prosthesis With Sensations

NCT03350061 | Completed

• 1 other identifier: Osecaj Opet
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation; Phantom Limb Pain; Sensory Deficit

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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.

  within 3 months post implant

Secondary Outcomes (8)

• Impact of SENSY on phantom pain: neuropathic pain symptom inventory score

  within 3 months post implant

• Impact of SENSY on phantom pain: visual analog scale score

  within 3 months post implant

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

  until up to 3 months post explant

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

  until up to 3 months post explant

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

  within 3 months post implant

Study Arms (1)

SENSY benefit

EXPERIMENTAL

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

Interventions

SENSY DEVICE

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.

SENSY benefit

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Centre of Serbia: lead
• Axonic: collaborator
• SensArs Neuroprosthetics Sarl: collaborator
• Institut für Mikrosystemtechnik (IMTEK), Albert-Ludwigs-Universität Freiburg: collaborator
• Ripple LLC: collaborator
• Össur hf: collaborator

Study Sites (1)

Clinical center of Serbia

Belgrade, RS, 11000, Serbia

Location

Related Publications (4)

• 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.

  PMID: 38378671 DERIVED

• 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.

  PMID: 35461007 DERIVED

• 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.

  PMID: 33417885 DERIVED

• 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.

  PMID: 31501600 DERIVED

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Aleksandar Lešić, Prof

  Clinical center of Serbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: November 12, 2017
• First Posted: November 22, 2017
• Study Start: November 12, 2017
• Primary Completion: August 1, 2018
• Study Completion: July 14, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

SE (1)