NCT02006433|CompletedDMCFDA Device
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Department of Defense
interventional
4
1 country
2
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2017
Actual (reported)Study Completion
September 2017
Actual (reported)The purpose of this research study is to determine if DBS is a feasible, safe and effective therapy for pain and autonomic dysreflexia after spinal cord injury.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 25, 2013
Actual (reported)December 2013
Date type not reportedThis date has not been verified as actual or estimated.
December 10, 2013
Actual (reported)September 2017
Actual (reported)September 2017
Actual (reported)Change in Pain as measured by Neuropathic Pain Symptom Inventory (NPSI)
Neuropathic Pain Symptom Inventory (NPSI) is a 12 item questionnaire with each question scored form 0-10 with the highest score indicating greater pain
Baseline, up to 52 weeks
Change in Pain as measured by Multidimensional pain Inventory (MPI-SCI)
Multidimensional pain Inventory (MPI-SCI) is a self-report questionnaire consisting of 50 items, each questioned scored from 0-6, with the higher score being the greatest impact of pain on an individuals daily life.
Baseline, up to 52 weeks
Change in Pain as measured by the Basic Pain Data Set
The Basic Pain Data set is a 4 question assessing change in pain in the past week using 0-6 scale on each item with the higher score indicating greater pain intensity
Baseline, up to 52 weeks
Deep brain stimulation (DBS) for the alleviation of chronic neuropathic pain in patients with spinal cord injury (SCI). The stimulation will be applied bilaterally or unilaterally in the midbrain periaqueductal/periventricular gray region (PAG/PVG). Extended participation in the study, which will last approximately 2 more years, precisely 104 weeks.The purpose of this extended portion of the study is to obtain long-term follow-up information on safety and efficacy, in subjects that have opted to receive continuing brain stimulation. Investigators label weeks in terms of original enrollment. Thus the surgery occurs in weeks 7 and 8 and the original study finishes in week 52, with the extension lasting from week 53 to week 156.
Local anesthesis, MRI and CT scan of the brain followed by implantation of the stimulation device
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Miami Hospital
Miami, Florida, 33136, United States
VA Medical Center
Miami, Florida, 33136, United States
Jonathan R Jagid, M.D.
University of Miami
4 participants (actual enrollment reported by the registry).
First Submitted
October 25, 2013
First Posted
December 10, 2013
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease
Deep Brain Stimulation for the Treatment of Traumatic Brain Injury
Contact the study team to confirm eligibility.
Primary Completion
September 2017
Actual (reported)Study Completion
September 2017
Actual (reported)Last Updated
October 8, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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