Autonomic Dysreflexia, Pain
Conditions
Brief summary
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.
Interventions
DEVICEDeep Brain Stimulation
Local anesthesis, MRI and CT scan of the brain followed by implantation of the stimulation device
Sponsors
United States Department of Defense
Jonathan Jagid
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age 22-60 years of age 2. Level of injury at or above T12 3. Neuropathic pain at or below the level of injury, as determined based on pain in an area with neurological deficit and described as burning, shooting, electric, stinging etc. 4. The injury must have occurred at least 1 year prior to entering the study and participants must have experienced chronic pain for a minimum of six months. 5. The injury level must be at or above T12, and the disability must have a grade on the American Spinal Injury Association Impairment Scale (AIS) of ASIA-A, ASIA-B, ASIA-C or ASIA-D as determined by a qualified examiners. 6. Autonomic dysreflexia can be present, but is not a requirement. This is defined as a rise of systolic pressure by more than 30 mmHg during noxious skin stimulation or when the bladder or bowel is full, or apparently spontaneously over a period of minutes. 7. Pain (neuropathic) of moderate severity or greater is present, when the patient is taking medication, with a score of at least 4 on a numerical rating scale (range of 0 to 10). 8. Treatment with at least two of the following drug classes must have failed to give satisfactory pain relief within the last two years: anticonvulsants e.g., pregabalin, gabapentin); antidepressants (e.g., trazodone, amitriptyline); NSAIDS (e.g., ibuprofen). In addition, at least one of the following must have proved ineffective: exercise-based rehabilitation, massage therapy using a variety of methods, acupuncture using pressure, needles, heat, or electrical stimulation on specific points on the body and psychological interventions such as cognitive therapy. 9. The subject must be taking pain medication to maintain a stable level of medication from 4 weeks before surgery to 12 weeks after (the primary endpoint), except on the day of surgery. 10. Participants on medications for other conditions, such as diabetes, will be considered as candidates for this study. The dose will be monitored throughout the trial. (They will be excluded if the drug is being used to treat epilepsy, Parkinson's diseases, or other brain degenerative diseases.) 11. The subject must be willing to comply with the protocol including all scheduled visits. 12. Literate at 8th grade level or above. 13. Subject must provide a letter of clearance for the DBS surgery from primary care physician
Exclusion criteria
for Admission to study: 1. Unable to give informed consent 2. Prisoner or ward of the state 3. Pregnancy 4. Prior history of abusing nonprescribed drugs 5. Recent (one-year) history of alcohol abuse 6. ASIA motor exam unobtainable 7. History of cardiac arrhythmia 8. Renal disease, heart disease or uncontrolled hypertension (except due to autonomic dysreflexia), liver disease or hepatic cirrhosis 9. Active major medical or psychiatric illness 10. Significant post-traumatic encephalopathy from head trauma sustained at SCI 11. Languages without local expertise 12. Pain is only nociceptive, or due to muscle spasms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain as measured by Neuropathic Pain Symptom Inventory (NPSI) | Baseline, up to 52 weeks | Neuropathic Pain Symptom Inventory (NPSI) is a 12 item questionnaire with each question scored form 0-10 with the highest score indicating greater pain |
| Change in Pain as measured by Multidimensional pain Inventory (MPI-SCI) | Baseline, up to 52 weeks | 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. |
| Change in Pain as measured by the Basic Pain Data Set | Baseline, up to 52 weeks | 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 |
Countries
United States
Outcome results
None listed