Closed-loop Deep Brain Stimulation to Treat Refractory Neuropathic Pain

Completed · Not applicable · Has a placebo group

Conditions studied: Chronic Pain, Post Stroke Pain, Phantom Limb Pain, Spinal Cord Injuries

In brief

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.

Key facts

Study ID

NCT03029884

Run by

Prasad Shirvalkar, MD, PhD

People needed

4

Starts

2017-10-28

Expected to finish

2026-06-30

Last updated by the study team

2026-08-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 conditions that evaluating psychiatrist would recommend exclusion of patient after neuropsychiatric evaluation.
• Suicide attempt </= 12 months or imminent suicide risk
• History of substance abuse in past 3 years.
• Major medical co-morbidities increasing the risk of surgery including uncontrolled hypertension, severe diabetes, major organ system failure, history of hemorrhagic stroke, need for chronic anticoagulation other than aspirin, active infection, immunocompromised state or malignancy with < 5 years life expectancy
• Inability to stop Coumadin or platelet anti-aggregation therapy for surgery and after surgery. Patients taking these medications will need to discuss the need/risk of continuing these medications with their physicians and the PI or study personnel may contact the treating physician(s) as well to discuss the risks of anticoagulation / antiaggregation therapy discontinuation.
• Coagulopathy. Patients will be excluded unless assessed and cleared by hematology.
• MRI (done within one year of the first visit) with significant abnormalities other than those associated with the neurological disorder causing chronic pain.
• Implantable hardware not compatible with MRI or with the study.
• Inability to comply with study follow-up visits
• Previous ablative intracranial surgery for the management of the thalamic pain syndrome.
• Previously implanted with deep brain stimulation system or any previously implanted device treatment involving brain stimulation
• Major neurological disorder other than the one that led to the chronic pain including epilepsy, neurodegenerative condition or any history of seizure
• 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).
• Pregnancy or lack of regular use of contraceptives. Patients who become pregnant after enrollment may be excluded from the study. Patients who become pregnant prior to the surgical implantation of the DBS systems will be excluded from the study.
• Patients may be excluded from enrollment due to a condition that, in the judgment of the PI, significantly increases risk or reduces significantly the likelihood of benefit from DBS.

Where it is running

• University of California — San Francisco, California, United States

Full record on ClinicalTrials.gov

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