Feasibility of Sensory Feedback for Lower Limb Amputees

Description

The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with lower limb loss, including above and below knee amputees. The approach involves delivering small electrical currents directly to remaining nerves via implanted stimulating electrodes. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how information about the foot and lower limb used to be transferred to your brain prior to the amputation. Individuals also have the option to have recording electrodes implanted within muscles of the lower limb(s) in an attempt to develop a motor controller that would enable the user to have intuitive control of a robotic prosthetic leg.

Conditions

Amputation

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Study Overview

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Study Details

Study overview

The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with lower limb loss, including above and below knee amputees. The approach involves delivering small electrical currents directly to remaining nerves via implanted stimulating electrodes. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how information about the foot and lower limb used to be transferred to your brain prior to the amputation. Individuals also have the option to have recording electrodes implanted within muscles of the lower limb(s) in an attempt to develop a motor controller that would enable the user to have intuitive control of a robotic prosthetic leg.

Feasibility of Sensory Feedback for Lower Limb Amputees

Feasibility of Sensory Feedback for Lower Limb Amputees

Condition
Amputation
Intervention / Treatment

-

Contacts and Locations

Cleveland

Louis Stokes VA Medical Center, Cleveland, Ohio, United States, 44106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Louis Stokes VA Medical Center,

Ronald Triolo, PhD, PRINCIPAL_INVESTIGATOR, Louis Stokes VA Medical Center

Study Record Dates

2027-09-01