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Clinical Evaluation of Direct Dorsal Column Stimulation

TerminatedNot applicableNCT02020460
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 study will examine the feasibility of Direct Dorsal Column Stimulation using existing Stimulation Leads (Ad-Tech). Secondary endpoints will include pain relief, somatosensory evoked potentials (SSEPs), stimulator settings required, improvement in quality of life and use of pain medications.

Study details

Official title
A Clinical Evaluation of Direct Dorsal Column Stimulation for the Management of Chronic, Medically Refractory Neuropathic Pain
Interventions
  • Device: Subdural trial lead
  • Device: Epidural trial lead
Sponsor
Duke University
Start date
2012-06
Primary completion
2014-08
Sex
All
Age range
from 18 Years to 75 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: Subjects enrolled in this study must meet the following inclusion criteria: 1. Primary pain type-neuropathic with concordant neurologic findings 2. Subject age is 18 years or older; 3. Subjects who meet one of the following four criteria: 1. diagnosed with medically refractory chronic neuropathic pain, post laminectomy pain syndrome or failed back surgery syndrome. 2. previously had successful SCS, but gradually became refractory 3. did not have adequate coverage during a prior SCS trial, 4. been deemed refractory to all other treatments and would otherwise receive an intrathecal catheter/pump for chronic narcotics administration 4. Disease duration of at least 6 months with no lasting success with standard therapy and medications. 5. Mean pain intensity of at least 5 cm (or greater), measured on a visual analog scale from 0 (no pain) to 10 cm (severe pain) on a 10 cm line; 6. Psychological screening has been completed and the patient has been cleared by a psychologist or psychiatrist as a suitable SCS candidate; 7. Subject is willing to cooperate with the study requirements including compliance with the treatment regimen, the follow-up visit schedule and completion of the study diary; 8. Female candidates of childbearing potential must have a negative serum pregnancy test. 9. MRI or CT myelogram of the lumbar and thoracic spine (within 12 months prior to screening) rules out a pathology that might compromise SCS electrode placement or pathology, in addition to neural compression that might contribute to the subject's pain 10. Provide informed consent to participate in the study; - Exclusion Criteria: A subject will be excluded from participation in this study if they meet any one of the following criteria: 1. Pain attributed to: vascular disorder; musculoskeletal disorder; substance abuse or withdrawal; infection; disorder of homeostasis; 2. Subjects currently participating in another clinical trial; 3. Subject has an existing intrathecal drug pump 4. Active local or systemic infection 5. Unresolved issues of secondary gain (e.g., litigation) 6. Expected inability to adequately report treatment outcome 7. A concurrent clinically significant or disabling chronic pain problem or condition that is likely to confound evaluation of study endpoints (e.g., chronic migraine, significant arthritis of the hip associated with groin pain as primary complaint) 8. Radiographic evidence of frank instability (grossly mobile spondylolisthesis or abnorm…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02020460