Clinical Evaluation of Direct Dorsal Column Stimulation (DDCS)
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|ClinicalTrials.gov Identifier: NCT02020460|
Recruitment Status : Terminated (low accrual)
First Posted : December 25, 2013
Last Update Posted : February 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Failed Back Surgery Syndrome||Device: Subdural trial lead Device: Epidural trial lead||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Crossover Assignment|
|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|
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
- 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.
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
|United States, North Carolina|
|Duke University Health Systems|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Nandan Lad, MD, PhD||DUMC|