Status:
COMPLETED
Prosthesis With Sensations
Lead Sponsor:
Clinical Centre of Serbia
Collaborating Sponsors:
Axonic
SensArs Neuroprosthetics Sarl
Conditions:
Amputation
Phantom Limb Pain
Eligibility:
All Genders
18-70 years
Phase:
NA
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 pr...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03350061
Start Date
November 12 2017
End Date
July 14 2020
Last Update
July 15 2020
Active Locations (1)
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1
Clinical center of Serbia
Belgrade, RS, Serbia, 11000