Amputation Clinical Trial
Official title:
Restoration of Sensations From the Lost Limb to Amputees for Fall Avoidance, Regular Walking, Phantom Limb Pain Diminishment and Embodiment of Prosthesis
Verified date | July 2020 |
Source | Clinical Centre of Serbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3 |
Est. completion date | July 14, 2020 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Serbia | Clinical center of Serbia | Belgrade | RS |
Lead Sponsor | Collaborator |
---|---|
Clinical Centre of Serbia | Axonic, Institut für Mikrosystemtechnik (IMTEK), Albert-Ludwigs-Universität Freiburg, Össur hf, Ripple LLC, SensArs Neuroprosthetics Sarl |
Serbia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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). | within 3 months post implant | |
Secondary | 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). | within 3 months post implant | |
Secondary | 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. | until up to 3 months post explant | |
Secondary | 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. | until up to 3 months post explant | |
Secondary | 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. | within 3 months post implant | |
Secondary | 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. | within 3 months post implant | |
Secondary | 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. | within 3 months post implant | |
Secondary | Impact of SENSY on cortical plasticity | Average cortical reorganization measured through functional Magnetic Resonance Imaging between after the implant and after the explant. | within 3 months post explant |
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