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Deep Brain Stimulation (DBS) in Patients With Refractory Chronic Neuropathic Pain (NCT03029884)

United States Department of Defense
This study evaluates invasive deep brain stimulation (DBS) in the treatment of chronic neuropathic pain. Half of the participants will be assigned to a group with recording / stimulation to one pain-related circuit of the brain while the other half of participants will be assigned to recording / stimulation to a different pain-related circuit of the brain. Relief of pain symptoms with stimulation will be studied in both groups. It is hypothesized that neural signals will correlate with pain states and that DBS can disrupt these pain states in both groups.
  • Device: Medtronic Activa PC+S (Chronic brain recording and stimulation)
    Two pain-related pathway regions will be implanted, recorded from and stimulated in patients. Recorded neural data will inform stimulation parameters that may decrease pain states.
    • Medtronic Activa PC+S
Ages eligible for Study
21 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • Age > 21
  • Chronic refractory neuropathic pain with the following etiologies:
  • post-traumatic pain syndromes (e.g. root avulsions, nerve crush injuries, spinal cord injury)
  • postsurgical pain syndromes (eg, postmastectomy syndrome, postthoracotomy syndrome, phantom limb pain, post surgical spinal pain)
  • postherpetic neuralgia
  • complex regional pain syndrome
  • atypical facial pain
  • central pain syndromes (i.e. poststroke pain, multiple sclerosis pain, postradiation pain)
  • post-radiation plexopathy
  • Sufficiently severe pain symptoms, in spite of best medical therapy (e.g. two or more pain medications from different classes, spinal injections), that is of > 1 year in duration
  • Ability to speak and read English
  • Ability to give informed consent for the study
  • Stable doses of medications (e.g. anticonvulsant drug, anti-depressants, and opioids)
  • A minimum visual analog scale (VAS) score for pain of 6 or greater, recently prior to (i.e. within 48 hours) or during baseline assessment.
Exclusion Criteria:
  • Pregnancy or breast-feeding
  • Inability to speak and / or read English
  • Inability to give consent
  • Significant cognitive impairment or Dementia (MoCA < 25)
  • Active depression (BDI > 20) or other psychiatric illness (active general anxiety disorder, schizophrenia, bipolar disorder, obsessive-compulsive disorder (OCD), or personality disorders (e.g. multiple personality disorder, borderline personality disorder, etc.)
  • History of suicide attempt or suicidal ideation
  • History of substance abuse
  • Co morbidities including ongoing anticoagulation, uncontrolled hypertension or major organ system failure
  • Abnormal MRI (excessive atrophy and lesion)
  • Inability to comply with study follow-up visits
  • Any prior intracranial surgery
  • History of seizures
  • Immunocompromised
  • Has an active infection
  • Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition
  • Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump
  • Allergies or known hypersensitivity to materials in the Activa PC+S system (i.e. titanium, polyurethane, silicone, polyetherimide, stainless steel).
The purpose of this study is to test the efficacy of DBS in a small cohort of patients with chronic pain refractory to conventional treatments. The study will involve the implantation of a neurostimulator, the Medtronic Activa PC+S device, to examine the efficacy of two modes of DBS. Open-loop DBS will provide stimulation based on a pre-set schedule, whereas closed-loop DBS will deliver stimulation based on brain activity associated with pain states. The goals of this study are to identify neurophysiological correlates of elevated pain states and find DBS parameters that disrupt pain-related brain activity and provide pain relief with little or no side effects. The efficacy of site-specific stimulation will also be studied.
Status:
not yet recruiting
Type:
Interventional
Phase:
-
Start:
31 May, 2017
Updated:
19 January, 2017
Participants:
10
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