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Clinical Evaluation of Direct Dorsal Column Stimulation (DDCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020460
Recruitment Status : Terminated (low accrual)
First Posted : December 25, 2013
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Failed Back Surgery Syndrome Device: Subdural trial lead Device: Epidural trial lead Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Device Feasibility
Official Title: A Clinical Evaluation of Direct Dorsal Column Stimulation for the Management of Chronic, Medically Refractory Neuropathic Pain
Study Start Date : June 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Active Comparator: Subdural trial lead
SCS trial lead in the subdural space.
Device: Subdural trial lead
Active Comparator: Epidural trial lead
SCS trial lead in the epidural space.
Device: Epidural trial lead



Primary Outcome Measures :
  1. Feasibility as measured by interview and questionnaire [ Time Frame: 3-5 days after Successful SCS trial lead placement defined as at least 50% reduction in pain or adequate paresthesia coverage in the painful areas. ]
    The subject will be asked to complete various questionnaires about their pain characteristics, consisting of pain rating scales and subjective recordings and ratings of stimulation intensity, duration, timing and location of pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 abnormal subluxation) requiring fusion, calcific arachnoiditis, or severe thoracic or lumbar stenosis.
  9. Subjects who have a condition that requires diathermy or repeat MRI's;
  10. New medication for pain control has been initiated within 8 weeks prior to the initial baseline;
  11. Female candidates of child bearing potential who are pregnant (confirmed by positive serum pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child;
  12. Subject has a blood clotting disturbance or requires chronic anticoagulant drug therapy
  13. The Investigator deems that the subject is not suitable for the study even if they meet all other inclusion/exclusion criteria.

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): NCT02020460


Locations
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United States, North Carolina
Duke University Health Systems
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Nandan Lad, MD, PhD DUMC
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02020460    
Other Study ID Numbers: Pro00036722
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: August 2015
Keywords provided by Duke University:
post-laminectomy pain syndrome,
refractory,
refractory chronic neuropathic pain,
failed back surgery syndrome.
Additional relevant MeSH terms:
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Syndrome
Failed Back Surgery Syndrome
Disease
Pathologic Processes
Postoperative Complications
Back Pain
Pain
Neurologic Manifestations