Brain implant that turns on only when pain strikes shows promise
NCT ID NCT03029884
First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times
Summary
This study tests a new way to use deep brain stimulation for people with severe, treatment-resistant chronic pain from stroke, spinal cord injury, or phantom limb pain. Instead of constant stimulation, the device delivers electrical pulses only when the brain senses high pain signals, which may prevent the brain from adapting and losing relief. The goal is to see if this personalized approach provides lasting pain reduction for a small group of 4 participants.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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4 people
The number who actually took part.
- Started
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Oct 2017
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of California
San Francisco, California, 94143, United States
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Other studies related to the condition(s) this trial covers.
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