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Spinal Cord Stimulation (SCS) for Amputees

NCT ID: NCT04490382

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-20

Study Completion Date

2022-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Somatosensory Perception Following Lower Limb Amputation

Keywords

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Neuromodulation Phantom pain Amputation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patients undergoing Neuromodulation

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

Group Type EXPERIMENTAL

32 channel external stimulator

Intervention Type DEVICE

Patients will be stimulated by the 32 channel external stimulator via leads placed as part of standard care neuromodulation. Then patients will undergo various tasks.

Interventions

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32 channel external stimulator

Patients will be stimulated by the 32 channel external stimulator via leads placed as part of standard care neuromodulation. Then patients will undergo various tasks.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nandan Lad, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Other Identifiers

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Pro00102757

Identifier Type: -

Identifier Source: org_study_id