Closed-loop Deep Brain Stimulation to Treat Refractory Neuropathic Pain
CompletedNot applicableNCT03029884
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Deep brain stimulation (DBS) holds promise as a new option for patients suffering from treatment-resistant chronic pain, but current technology is unable to reliably achieve long-term pain symptom relief. A "one-size-fits-all" approach of continuous, 24/7 brain stimulation has helped patients with some movement disorders, but the key to reducing pain may be the activation of stimulation only when needed, as this may help keep the brain from adapting to stimulation effects. By expanding the technological capabilities of an investigative brain stimulation device, the investigators will enable the delivery of stimulation only when pain signals in the brain are high, and then test whether this more personalized stimulation leads to reliable symptom relief for chronic pain patients over extended periods of time.
Study details
- Official title
- Technology Development for Closed-loop Deep Brain Stimulation to Treat Refractory Neuropathic Pain
- Conditions
- Chronic Pain
- Post Stroke Pain
- Phantom Limb Pain
- Spinal Cord Injuries
- Interventions
- Device: Open-Loop DBS
- Device: Sham Stimulation
- Device: Closed-Loop DBS
- Sponsor
- Prasad Shirvalkar, MD, PhD
- Collaborators
- United States Department of Defense; National Institute of Neurological Disorders and Stroke (NINDS)
- Organization
- University of California, San Francisco
- Start date
- 2017-10-28
- Primary completion
- 2023-09-30
- Sex
- All
- Age range
- from 21 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age ≥ 21 years * Clinical diagnosis of post-stroke pain (thalamic pain), spinal cord injury or phantom limb pain with allodynia or dysesthesia with pinprick anesthesia or hypoesthesia on the affected hemibody or limb (anesthesia dolorosa). * For Post-Stroke Pain: Stroke of ischemic etiology only. MRI done within one year of the first visit showing a lesion that involves the contralateral brainstem, thalamus or cortex. The lesion will involve cortical-subcortical areas in topography consistent with sensory thalamocortical connections. This will include patients with infarcts in the territory of the middle cerebral artery or those with cavernous malformations. A more recent MRI may be required if the patient's condition changed within the previous year. * For Phantom limb pain: MRI done within one year not showing any contraindication to surgery such as mass, lesion, hemorrhage or other abnormality near target * For Spinal Cord Injury pain: MRI done within one year not showing contraindication to surgery such as mass, lesion, hemorrhage or other abnormality near target * One year or more of medically refractory severe pain (see below) * Average daily pain for the past 30 days reported as \>5 on a 0-10 numeric rating scale (NRS) * Failure to respond adequately to at least one antidepressant, one anti-seizure medication and one oral narcotic with current stable doses of medications. * Ability to speak / read English * Capable of understanding and providing informed consent * Stable doses of pain medications (e.g. anticonvulsant drug, anti-depressants, and opioids etc.) * Women of childbearing age must be on regular use of an accepted contraceptive method(s). Exclusion Criteria: * Study subjects will be adults with refractory chronic neuropathic pain. * Pregnancy or breast feeding * Inability to speak and / or read English * Inability to give informed consent * Significant cognitive impairment or Dementia (MoCA \< 25) * Aphasia severe enough to limit the consent process or communication between the investigators and the patient. Patients with mild or recovering aphasia may be considered candidates at the discretion of the PI. * Active depression (BDI \> 20) or other untreated or uncontrolled 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.) or other neuropsychiatric c…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03029884