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Spinal Cord Stimulation (SCS) for Amputees

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ClinicalTrials.gov Identifier: NCT04490382
Recruitment Status : Withdrawn (Funding)
First Posted : July 29, 2020
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Somatosensory Perception Following Lower Limb Amputation Device: 32 channel external stimulator Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluate Tactile Sensation and Proprioception in Lower Limb Amputees Using Neuromodulation
Estimated Study Start Date : September 20, 2020
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in stimulation as reported by patients [ Time Frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours) ]
  2. Change in stimulation parameters as measured by frequency [ Time Frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours) ]
  3. Change in stimulation parameters as measured by pulse width [ Time Frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours) ]
  4. Change in stimulation parameters as measured by amplitude [ Time Frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours) ]
  5. Change in pain score as measured by McGill Pain Questionnaire [ Time Frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours) ]

Secondary Outcome Measures :
  1. Change in gait parameters as measured by step frequency [ Time Frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours) ]
  2. Change in passive movement detection as measured by external sensors [ Time Frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours) ]
  3. Change in cortical reorganization measured by Electroencephalogram (EEG) [ Time Frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04490382


Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Nandan Lad, MD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04490382    
Other Study ID Numbers: Pro00102757
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Duke University:
Neuromodulation
Phantom pain
Amputation