Recruiting

Electrical Stimulation

Sponsor:

Louis Stokes VA Medical Center

Code:

NCT03409133

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stimulating nerve electrodes and intramuscular recording electrodes

Study Details

Brief summary:

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

Study ID

NCT03409133

Start date

Nov 5, 2015

Status verified date

Mar, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults age 18 or greater
  • Chronic, medically stable ( > 3 months) trans-tibial or trans-femoral amputation at the time of implant surgery.
  • 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 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 to a degree that would preclude surgery
  • 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
  • Severe neurological conditions that significantly impair balance or mobility to an extent that independent ambulation is impossible without assistance ( as determined by a healthcare provider)
  • Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
  • Poor surgical candidate
  • Psychiatric or cognitive conditions that could affect cooperation or understanding of instructions and willingness to undergo psychological evaluation, if recommended by study surgeons or investigators.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Stimulating nerve electrodes & intramuscular recording electrodes

Fifteen subjects with lower limb amputation will have multi-contact stimulating nerve cuff electrodes implanted around the nerves in their residual limb. These electrodes will be connected to temporary percutaneous leads.

During experimental testing, a small amount of electrical current will be delivered to the nerves through multi-contact nerve cuff electrodes.

Participants also have the option to have recording electrodes implanted within muscles in their lower limb(s). These muscles are associated with prosthetic movement, and recordings from these muscles will be used to develop a controller for a robotic myoelectric prosthesis.

Interventions

Stimulating nerve electrodes and intramuscular recording electrodes

See Arm Description

Primary outcome measure

  • Stimulation Thresholds [ Time Frame: 9 months post implant ]
  • Functional Gait Assessment (FGA) [ Time Frame: 1 year post implant ]

Central Contacts and Locations

Central contacts

Aarika Sheehan, PT, DPT

216-791-3800Aarika.Sheehan@va.gov

jessica jarvela, MS

216-769-0531jessica.jarvela@va.gov

Locations

Louis Stokes VA Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Aarika Sheehan, PT, DPT

216-791-3800Aarika.Sheehan@va.gov

Principal Investigator:

Ronald Triolo, PhD

More Information

Sponsor

Louis Stokes VA Medical Center

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

  • prosthesis user
  • phantom sensation
  • sensory feedback
  • prosthesis
  • amputee
  • amputation
  • limb loss
  • robotic prosthesis
  • neuroprosthesis
  • sensory restoration
  • robotic
  • electromyography
  • EMG
  • sensation
  • myoelectric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louis Stokes VA Medical Center on 2026-03-06.