Clinical trial NCT02006433: Treatment of Pain and Autonomic Dysreflexia in Spinal Cord Injury With Deep Brain Stimulation
Official title: Treatment of Pain and Autonomic Dysreflexia in Spinal Cord Injury With Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Autonomic Dysreflexia
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2013-12-10
Enrollment: 4
Sex: ALL
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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

Exclusion Criteria for Treatment/Intervention procedure:

1. Coagulopathy requiring anticoagulation therapy
2. Thrombocytopenia or platelet dysfunction
3. Peripheral vascular disease
4. Comorbid neurological diseases or disorders, including a history of seizures
5. Active systemic infection or concurrent immunosuppressive therapy
6. Existing implantable cardiac pacemaker, defibrillator,or neurostimulator
7. Requiring short-wave or microwave diathermy treatment
8. Inability to cooperate
9. Any contraindication to MRI studies (All future MRIs, with the exception of brain MRIs, are excluded.)
10. Adverse reaction to stimulation (such as inability to stimulate at analgesic levels without causing clinical hypertension or hypotension) or allergy or hypersensitivity to any materials of the neurostimulation system
11. Depression, as defined by a Beck Depression Inventory (BDI-1a) score above 30.
12. Subjects with any clinically significant abnormality, not expected on the basis of age (age-related), that is seen in magnetic resonance imaging (MRI).

Primary outcomes:
measure: Change in Pain as measured by Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Baseline, up to 52 weeks
measure: Change in Pain as measured by Multidimensional pain Inventory (MPI-SCI)
timeFrame: Baseline, up to 52 weeks
measure: Change in Pain as measured by the Basic Pain Data Set
timeFrame: Baseline, up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Miami
country: United States
facility: VA Medical Center
state: Florida
Study officials:
affiliation: University of Miami
name: Jonathan R Jagid, M.D.
role: PRINCIPAL_INVESTIGATOR
References: