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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-12-1-0559 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep Brain Stimulation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation | Device | Local anesthesis, MRI and CT scan of the brain followed by implantation of the stimulation device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria for Admission to study:
Exclusion Criteria for Treatment/Intervention procedure:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan R Jagid, M.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Hospital | Miami | Florida | 33136 | United States | ||
| VA Medical Center |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2015 | May 14, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D020211 | Autonomic Dysreflexia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001342 | Autonomic Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Miami |
| Florida |
| 33136 |
| United States |
| D009422 | Nervous System Diseases |
| D013119 | Spinal Cord Injuries |
| D020196 | Trauma, Nervous System |