TerminatedNot Applicable

Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees, 90-Day

Stopped: Additional participants were not enrolled after multiple years of recruitment efforts. Funding expired.

United States4 participantsStarted 2021-05-27

Plain-language summary

The goals of this study are to provide sensory information to amputees and reduce phantom limb pain via electrical stimulation of the lumbar spinal cord and spinal nerves. The spinal nerves convey sensory information from peripheral nerves to higher order centers in the brain. These structures still remain intact after amputation and electrical stimulation of the dorsal spinal nerves in individuals with intact limbs and amputees has been demonstrated to generate paresthetic sensory percepts referred to portions of the distal limb. Further, there is recent evidence that careful modulation of stimulation parameters can convert paresthetic sensations to more naturalistic ones when stimulating peripheral nerves in amputees. However, it is currently unclear whether it is possible to achieve this same conversion when stimulating the spinal nerves, and if those naturalistic sensations can have positive effects on phantom limb pain. As a first step towards those goals, in this study, the investigators will quantify the sensations generated by electrical stimulation of the spinal nerves, study the relationship between stimulation parameters and the quality of those sensations, measure changes in control of a prosthesis with sensory stimulation, and quantify the effects of that stimulation on the perception of the phantom limb and any associated pain.

Who can participate

Age range22 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Subjects must be over 6 months post-amputation at the time of lead placement.
✕. Subjects must be between the ages of 22 and 70 years old. Participants outside this age range may be at an increased medical risk and have an increased risk of fatigue during testing.
✕. Subjects must have used their current prosthesis for at least 6 months and achieved at least K-1 ambulator status at the time of lead placement, as determined by the Amputee Mobility Predictor.
✕. Subjects must not have any serious disease or disorder that could affect their ability to participate in this study.
✕. Female subjects of childbearing age must not be pregnant or breast-feeding.
✕. Subjects must not be receiving medications that affect blood coagulation.
✕. Subjects must not have an allergy to contrast medium or renal failure that could be exacerbated by the contrast agent used in MRIs. For this study, renal insufficiency will be determined through blood work and defined as BUN of 30 or less and Creatinine of 1.5 or less.
✕. Subjects may not have a hemoglobin A1c level above 8.0 mg/dl at time of implant.

What they're measuring

Number of Participants Experiencing Serious Device-related Adverse Events up to 90 Days Following Implantation

Timeframe: 90 days

Minimum Amplitude of Pulse Required to Evoke Sensory Percepts

Timeframe: 90 days

Minimum Charge Required to Evoke a Neurophysiological Response

Timeframe: 90 days

Location of Evoked Sensation - Missing Toes

Timeframe: 90 days

Location of Evoked Sensation - Plantar Surface of Missing Foot

Timeframe: 90 days

Trial details

NCT IDNCT04547582

SponsorLee Fisher, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-03

Results submitted2025-11-20

View on ClinicalTrials.gov More Traumatic Amputation of Lower Extremity trials

Plain-language summary

Who can participate

Age range22 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Subjects must be over 6 months post-amputation at the time of lead placement.
✕. Subjects must be between the ages of 22 and 70 years old. Participants outside this age range may be at an increased medical risk and have an increased risk of fatigue during testing.
✕. Subjects must have used their current prosthesis for at least 6 months and achieved at least K-1 ambulator status at the time of lead placement, as determined by the Amputee Mobility Predictor.
✕. Subjects must not have any serious disease or disorder that could affect their ability to participate in this study.
✕. Female subjects of childbearing age must not be pregnant or breast-feeding.
✕. Subjects must not be receiving medications that affect blood coagulation.
✕. Subjects must not have an allergy to contrast medium or renal failure that could be exacerbated by the contrast agent used in MRIs. For this study, renal insufficiency will be determined through blood work and defined as BUN of 30 or less and Creatinine of 1.5 or less.
✕. Subjects may not have a hemoglobin A1c level above 8.0 mg/dl at time of implant.

What they're measuring

Number of Participants Experiencing Serious Device-related Adverse Events up to 90 Days Following Implantation

Timeframe: 90 days

Minimum Amplitude of Pulse Required to Evoke Sensory Percepts

Timeframe: 90 days

Minimum Charge Required to Evoke a Neurophysiological Response

Timeframe: 90 days

Location of Evoked Sensation - Missing Toes

Timeframe: 90 days

Location of Evoked Sensation - Plantar Surface of Missing Foot

Timeframe: 90 days