Status:

WITHDRAWN

Spinal Cord Stimulation (SCS) for Amputees

Lead Sponsor:

Duke University

Conditions:

Somatosensory Perception Following Lower Limb Amputation

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The purpose of this study is to investigate how leg amputee patients can feel sensations with neuromodulation while they are using a prosthetic leg. "Neuromodulation" is the process by which the nervo...

Eligibility Criteria

Inclusion

  • Subject is at least 18 years of age
  • Subject is able and willing to comply with the schedule and protocol
  • Subject is a lower limb amputee who uses a prosthetic leg
  • Subject is a good candidate for implantation of a stimulator for their amputation related pain
  • Subject has stable neurological/cognitive function in the past 30 days
  • Subject is able to provide informed consent

Exclusion

  • Subject is currently participating in a clinical investigation that includes an active treatment arm
  • Subject currently has an active implantable device including an Implantable Cardioverter Defibrillator (ICD), pacemaker, spinal cord stimulator, or intrathecal drug pump
  • Subject is a prisoner
  • Female subject whom are pregnant

Key Trial Info

Start Date :

September 20 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 31 2022

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04490382

Start Date

September 20 2020

End Date

May 31 2022

Last Update

December 14 2020

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