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Intradural Percutaneous Stimulation

WithdrawnNot applicableNCT03380104
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The purpose of the study is to test the effects of intradural, spinal cord stimulation using a device placed in the same manner as a lumbar drain performed during a standard epidural spinal cord stimulation (SCS) trial routinely performed prior permanent lead and stimulation device implantation.

Study details

Official title
Intradural Percutaneous Stimulation - Inducing Physiological Responses.
Conditions
Interventions
  • Device: Intradural Spinal Cord Stimulation
  • Behavioral: Administration of Questionnaires
Sponsor
Matthew Howard
Organization
University of Iowa
Start date
2020-06-01
Primary completion
2020-06-01
Sex
All
Age range
from 18 Years to 85 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patients with neuropathic pain and concordant neurological findings previously consented for an epidural spinal cord stimulator trial * Patients greater than 18 years of agree * Must have one of the following: 1. Diagnosed with medically refractory chronic neuropathic pain, post laminectomy pain syndrome, or failed back surgery syndrome and planning to undergo a spinal cord stimulation trial 2. Been deemed refractory to all other treatments and would otherwise receive an intrathecal catheter/pump for chronic narcotic administration * Disease duration of at least 6 months with no lasting success with standard therapies or medications with exception of spinal cord stimulation * Mean pain intensity of a least 5 (or greater) measured on a visual analogue scale from 0 (no pain) to 10 (severe pain) * MRI or CT Myelogram of the lumbar and thoracic spine (within 12 months prior to screening) * No compressive spinal pathology or intradural implants (eg., syrinx shunt tubes) * Psychological screening has been completed and the patient has been cleared by a psychologist or psychiatrist as a suitable SCS candidate * Female patients of childbearing potential must have a negative serum pregnancy test * Patients agree to comply with the study protocol and have reviewed and given written informed consent Exclusion Criteria: * Patients who are unable or unwilling to provide feedback regarding the response * Subject has an existing intrathecal drug pump * Pain is attributed to: vascular disorder; musculoskeletal disorder; substance abuse or withdrawal; infection; disorder of homeostasis * Subject is currently enrolled in another trial * History of coagulation disorders or patients on chronic anticoagulant or antiplatelet therapy that is not able to be safely held for 14 days * History of thoracic trauma or spinal surgery extending into the thoracic spine * History of arachnoiditis or intradural spinal surgery that would limit catheter insertion to the target site * Current clinically significant or disabling chronic pain problem or condition that is likely to confound evaluation of the study endpoints (i.e. chronic migraine, significant arthritis of the hip associated with primary groin pain complaint) * Radiographic evidence of frank spinal instability (gross mobile spondylolisthesis or abnormal subluxation requiring fusion, calcific arachnoiditis, or severe thoracic or lumbar stenosis * Subject has a condition that requires diathermy or repeated MRIs…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03380104