Spinal Cord Stimulation (SCS) for Amputees

Evaluate Tactile Sensation and Proprioception in Lower Limb Amputees Using Neuromodulation

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.

Study Overview

• Status: Withdrawn
• Conditions: Somatosensory Perception Following Lower Limb Amputation
• Intervention / Treatment: Device: 32 channel external stimulator

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients undergoing Neuromodulation; Patients, who have had a lower limb amputation and undergoing neuromodulation as part of standard of care.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Nandan Lad, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 20, 2020
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Neuromodulation; Amputation; Phantom pain
• Other Study ID Numbers: Pro00102757

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No