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

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ClinicalTrials.gov Identifier: NCT02006433
Recruitment Status : Completed
First Posted : December 10, 2013
Last Update Posted : September 21, 2017
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Jonathan Jagid, University of Miami

Brief Summary:

The Investigators propose an investigation of the safety of deep brain stimulation (DBS) for the alleviation of chronic neuropathic pain in patients with spinal cord injury (SCI).

Aim 1 is to determine whether DBS in the periaqueductal/periventricular gray region (PAG/PVG) of the brain at analgesic intensities produces any systemic or neurological adverse effects in patients with longstanding SCI (>1 year), either immediately or as a result of prolonged application for up 40 weeks.

Aim 2 is to determine whether acute application of DBS in the PAG/PVG influences the severity of spontaneous ongoing pain caused by longstanding SCI.

Aim 3 is to determine whether DBS in the PAG/PVG affects stimulus-evoked or persistent hypertension (a major sign of autonomic dysreflexia) in chronic SCI patients.

Aim 4 is to determine whether prolonged PAG/PVG stimulation (for 40 weeks) leads to cumulative changes in chronic pain severity or in the motor or autonomic symptoms of chronic SCI patients.


Condition or disease Intervention/treatment Phase
Pain Autonomic Dysreflexia Device: Deep Brain Stimulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Pain and Autonomic Dysreflexia in Spinal Cord Injury With Deep Brain Stimulation
Study Start Date : December 2013
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Deep Brain Stimulation
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).
Device: Deep Brain Stimulation
Local anesthesis, MRI and CT scan of the brain followed by implantation of the stimulation device
Other Name: The Medtronic Models 3387 and 3389 DBS Leads neurostimulation system for deep brain stimulation.

No Intervention: Extension
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.



Primary Outcome Measures :
  1. Pain [ Time Frame: Change from Baseline Weekly up to 52 weeks ]
    Throughout the study, the patient will be interviewed weekly by telephone at their home to assess pain; Institute for Clinical Systems Improvement (ISCI) basic pain dataset & Neuropathic pain Symptom Inventory (NPSI) and/or West Haven-Yale Multidimensional pain Inventory for persons with SCI (MPI-SCI), Quantitative sensory testing (QST), Allodynia testing will be administered.


Secondary Outcome Measures :
  1. Pain [ Time Frame: Monthly up to 12 months ]
    Pain, autonomic and voluntary motor function will be evaluated in greater detail by interview and neurological examination during patient visits every 4 weeks, when stimulator reprogramming (switching amplitude) will also be done. ASIA motor score (upper+lower), ASIA sensory score (upper+lower), Tilt table response exam, and/or Autonomic dysreflexia self-reporting (headache, sweating, etc.) Autonomic Standards Assessment (BP, heart rate (HR), sympathetic skin response) will be administered.

  2. general physical and mental wellbeing [ Time Frame: Weekly up to 52 weeks ]

    In weekly telephone interviews, a medication diary, autonomic self-assessment, Institute for Clinical Systems Improvement (ISCI plus NPSI scores and the Guy/Farrar Patient Global Impression of Change (PGIC). These will also be obtained (some in amplified form) during patient visits. In abbreviated testing that takes place every 4 weeks during participant visits, the following will be additionally measured.

    Beck Depression Inventory (BDI), Adverse event assessment, Vital signs, Autonomic Standards Assessment (BP, heart rate (HR), sympathetic skin response, etc.), West Haven-Yale multi-dimensional pain inventory for SCI (MPI-SCI).


  3. Autonomic motor function [ Time Frame: Monthly up to 12 months ]
    Pain, autonomic and voluntary motor function will be evaluated in greater detail by interview and neurological examination during patient visits every 4 weeks, when stimulator reprogramming (switching amplitude) will also be done. ASIA motor score (upper+lower), ASIA sensory score (upper+lower), Tilt table response exam, and/or Autonomic dysreflexia self-reporting (headache, sweating, etc.) Autonomic Standards Assessment (BP, heart rate (HR), sympathetic skin response) will be administered.

  4. Voluntary motor function [ Time Frame: Monthly up to 12 months ]
    Pain, autonomic and voluntary motor function will be evaluated in greater detail by interview and neurological examination during patient visits every 4 weeks, when stimulator reprogramming (switching amplitude) will also be done. ASIA motor score (upper+lower), ASIA sensory score (upper+lower), Tilt table response exam, and/or Autonomic dysreflexia self-reporting (headache, sweating, etc.) Autonomic Standards Assessment (BP, heart rate (HR), sympathetic skin response) will be administered.


Other Outcome Measures:
  1. Comprehensive testing of pain and autonomic function. [ Time Frame: On week 2 before surgery, on week 16 (9 weeks after the first surgery) and on weeks 32 and 52 (the post-surgical midpoint and endpoint of the study). ]
    comprehensive testing of pain and autonomic function will be done in addition to the routine tests on week 2 before surgery, on week 16 (9 weeks after the first surgery) and on weeks 32 and 52 (the post-surgical midpoint and endpoint of the study).



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Ages Eligible for Study:   22 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02006433


Locations
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United States, Florida
University of Miami Hospital
Miami, Florida, United States, 33136
VA Medical Center
Miami, Florida, United States, 33136
Sponsors and Collaborators
Jonathan Jagid
United States Department of Defense
Investigators
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Principal Investigator: Jonathan R Jagid, M.D. University of Miami

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Responsible Party: Jonathan Jagid, Associate Professor of Neurological Surgery and Neurology, University of Miami
ClinicalTrials.gov Identifier: NCT02006433     History of Changes
Other Study ID Numbers: 20120429
W81XWH-12-1-0559 ( Other Grant/Funding Number: Department of Defense )
First Posted: December 10, 2013    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Spinal Cord Injuries
Autonomic Dysreflexia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Autonomic Nervous System Diseases