Feasibility of Sensory Feedback for Lower Limb Amputees

  • STATUS
    Recruiting
  • End date
    Sep 1, 2024
  • participants needed
    10
  • sponsor
    Louis Stokes VA Medical Center
Updated on 26 January 2021
fitting
nerve conduction

Summary

The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb by applying small electrical current directly to the remaining sensory nerves via implanted stimulating electrodes. These small electrical currents cause the nerves to generate signals that are then transferred to your brain just like the information about the foot and lower limb used to be transferred to your brain prior to the amputation.

Description

Electrodes are surgically implanted on one to four nerves of the residual limb. An external stimulation device will send pulses to the electrodes. The participant will be asked what they feel, and to draw the location of any perceived sensation on schematic maps. A sensorized prosthesis will be worn and stimulation will be administered while the participant is engaging in various functional tasks, such as standing, walking or climbing stairs or with visual or mental distractions.

Details
Condition Amputation, Limb Preservation and Amputation
Treatment Multi contact electrode implant
Clinical Study IdentifierNCT03409133
SponsorLouis Stokes VA Medical Center
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults age 18 or greater
Chronic, medically stable ( > 3 months) unilateral trans-tibial or trans-femoral amputation
Potential user of trans-tibial or trans-femoral prostheses for standing or walking
Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials (SEP) and the like
Good skin integrity and personal hygiene
Absence of autoimmune deficiencies, seizure disorders or cardiac abnormalities contraindicating stimulation
Sufficient social support and personal ability to tolerate study procedures and comply with follow-up schedule

Exclusion Criteria

Uncontrolled diabetes with HbA1c greater than or equal to 69 mmol/mol (8.5%)
Significant vascular disease
Chronic skin ulcerations
Significant history of poor wound healing
Significant history of uncontrolled infections
Active infection
Significant pain in the residual or phantom limb
Pregnancy
Inability to speak English
Expectation that MRI will be required at any point for the duration of study or while percutaneous leads are in place
Arthritis in the area of implant
History of vestibular or movement disorders that would compromise balance or walking
Class II or III obesity (Body Mass Index > 35)
Poor surgical candidate
Uncontrolled depression, psychoses or cognitive impairments
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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