Clinical trial NCT04490382: Spinal Cord Stimulation (SCS) for Amputees
Official title: Evaluate Tactile Sensation and Proprioception in Lower Limb Amputees Using Neuromodulation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Somatosensory Perception Following Lower Limb Amputation
Keywords: Neuromodulation
Phantom pain
Amputation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Change in stimulation as reported by patients
timeFrame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
measure: Change in stimulation parameters as measured by frequency
timeFrame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
measure: Change in stimulation parameters as measured by pulse width
timeFrame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
measure: Change in stimulation parameters as measured by amplitude
timeFrame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
measure: Change in pain score as measured by McGill Pain Questionnaire
timeFrame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Secondary outcomes:
measure: Change in gait parameters as measured by step frequency
timeFrame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
measure: Change in passive movement detection as measured by external sensors
timeFrame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
measure: Change in cortical reorganization measured by Electroencephalogram (EEG)
timeFrame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Nandan Lad, MD
role: PRINCIPAL_INVESTIGATOR
References: