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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:

The current study attempts to utilize deep brain stimulation of the periaqueductal grey (PAG) for diminution of both neuropathic and nociceptive pain in spinal cord injury patients. Likewise, the study will look at the effects on autonomic function as well. Deep brain stimulation, as a treatment, has gained widespread use for the treatment of various movement disorders. It is currently approved for use by the FDA for treatment of Parkinsons Disease, Essential Tremor, and Dystonia. Over 100,000 implants have been performed worldwide for these indications. The safety profile is well defined.

Pain is a tremendous burden for those who suffer with SCI. Persistent pain below or at the injury level is experienced in 2/3rd of chronic SCI patients. As a result of this pain at least 1/3rd of this sub-population faces a severely reduced quality of life; some authorities consider this rate to be much higher, based on surveyed pain ratings. It was reported that 23% of a sample patients with cervical or high thoracic SCI and 37% with low thoracic or lumbosacral SCI would sacrifice sexual, bowel and bladder function for good pain relief.

SCI pain is typically a mixture of nociceptive pain, which is caused by activation of primary afferents' receptors, and neuropathic pain, which is caused by damage to the nervous system. Neuropathic pain of SCI is most frequently treated by anticonvulsant agents. There is good evidence from randomized control trials for some degree of effectiveness of gabapentin and pregabalin, with weaker evidence for valproic acid. Tricyclic antidepressants are also used to control SCI pain, but the supporting evidence is not as strong. Thus amitriptyline has proved somewhat effective when the patient is depressed, but trazodone was reported not to reduce post-SCI neuropathic pain more than placebo. Traditional analges
Sponsor: Jonathan Jagid

Current Primary Outcome: Pain [ Time Frame: Change from Baseline Weekly up to 52 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.
• 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).

• 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.
• 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.

Original Secondary Outcome: Same as current

Information By: University of Miami

Dates:
Date Received: October 25, 2013
Date Started: December 2013
Date Completion: September 2017
Last Updated: March 2, 2017
Last Verified: March 2017