Spinal Cord Stimulation (SCS) for Amputees

Not Applicable

Withdrawn

• Conditions: Somatosensory Perception Following Lower Limb Amputation
• Interventions: Device: 32 channel external stimulator

• Registration Number: NCT04490382
• Lead Sponsor: Duke University

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 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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-29
• Study Start: 2020-09-20
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-14
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing Neuromodulation	32 channel external stimulator	Patients, who have had a lower limb amputation and undergoing neuromodulation as part of standard of care.

Primary Outcome Measures

Name	Time	Method
Change in stimulation as reported by patients	Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in stimulation parameters as measured by frequency	Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in stimulation parameters as measured by pulse width	Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in stimulation parameters as measured by amplitude	Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in pain score as measured by McGill Pain Questionnaire	Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)

Secondary Outcome Measures

Name	Time	Method
Change in gait parameters as measured by step frequency	Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in passive movement detection as measured by external sensors	Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Change in cortical reorganization measured by Electroencephalogram (EEG)	Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)