Treatment of Pain and Autonomic Dysreflexia in Spinal Cord Injury With Deep Brain Stimulation

Completed · Not applicable

Conditions studied: Pain, Autonomic Dysreflexia

In brief

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.

Key facts

Study ID

NCT02006433

Run by

Jonathan Jagid

People needed

4

Starts

2013-12-01

Expected to finish

2017-09-01

Last updated by the study team

2020-10-08

Who can join

Age: 22 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 22-60 years of age
• Level of injury at or above T12
• 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.
• 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.
• 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.
• 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.
• 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).
• 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.
• 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.
• 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.)
• The subject must be willing to comply with the protocol including all scheduled visits.
• Literate at 8th grade level or above.
• Subject must provide a letter of clearance for the DBS surgery from primary care physician
• Exclusion Criteria for Admission to study:
• Unable to give informed consent
• Prisoner or ward of the state
• Pregnancy
• Prior history of abusing nonprescribed drugs
• Recent (one-year) history of alcohol abuse
• ASIA motor exam unobtainable
• History of cardiac arrhythmia
• Renal disease, heart disease or uncontrolled hypertension (except due to autonomic dysreflexia), liver disease or hepatic cirrhosis
• Active major medical or psychiatric illness
• Significant post-traumatic encephalopathy from head trauma sustained at SCI
• Languages without local expertise

Where it is running

• University of Miami Hospital — Miami, Florida, United States
• VA Medical Center — Miami, Florida, United States

Full record on ClinicalTrials.gov

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