CompletedNot Applicable

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

United States4 participantsStarted 2013-12

Plain-language 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.

Who can participate

Age range22 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Change in Pain as measured by Neuropathic Pain Symptom Inventory (NPSI)

Timeframe: Baseline, up to 52 weeks

Change in Pain as measured by Multidimensional pain Inventory (MPI-SCI)

Timeframe: Baseline, up to 52 weeks

Change in Pain as measured by the Basic Pain Data Set

Timeframe: Baseline, up to 52 weeks

Trial details

NCT IDNCT02006433

SponsorJonathan Jagid

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-09

View on ClinicalTrials.gov More Pain trials

Who can participate

Age range22 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Change in Pain as measured by Neuropathic Pain Symptom Inventory (NPSI)

Timeframe: Baseline, up to 52 weeks

Change in Pain as measured by Multidimensional pain Inventory (MPI-SCI)

Timeframe: Baseline, up to 52 weeks

Change in Pain as measured by the Basic Pain Data Set

Timeframe: Baseline, up to 52 weeks