Spinal Cord Stimulation (SCS) for Amputees

Duke University

Status: Withdrawn

Conditions: Somatosensory Perception Following Lower Limb Amputation

Treatments: Device: 32 channel external stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT04490382

Pro00102757

Details and patient eligibility

About

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 nervous system can be regulated by targeted delivery of a stimulus, such as electrical stimulation or chemical agents, to specific neurological sites in the body. In this study, the investigators plan to use either electrical stimulation of the spinal cord (Spinal Cord Stimulation) or electrical stimulation of the dorsal root ganglion (DRG stimulation) as methods for neuromodulation.

Participation in this study will involve visiting the K-Lab (Human Performance Laboratory) at Duke's Sports Medicine Institute once prior to trial implant surgery, if feasible, and four times during the two weeks following the implantation of trial stimulation leads to evaluate sensations related to touch and position of the prosthetic leg as they are generated by neuromodulation.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Patients undergoing Neuromodulation

Experimental group

Description:

Patients, who have had a lower limb amputation and undergoing neuromodulation as part of standard of care.

Treatment:

Device: 32 channel external stimulator