Could zapping the brain ease stubborn nerve pain?
NCT ID NCT07057206
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 4 times
Summary
This early study tests a brain stimulation device for people with long-term nerve pain that hasn't responded to other treatments. The device is surgically placed to send mild electrical pulses to specific brain areas. The main goal is to see if the procedure is feasible and acceptable, and whether it can reduce pain compared to a sham (inactive) stimulation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brain stimulation device (Abbott Eterna IPG and Lamitrode 44 paddles)
- What this could lead to
- If it works, this could point toward a new way to treat hard-to-manage nerve pain without long-term medication.
- What could go wrong
- This is a very early, small trial with only 20 people. It is testing feasibility first, so it may not show clear pain relief, and brain surgery carries risks like infection or bleeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- 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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22 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 22 years * Clinical diagnosis of a refractory chronic neuropathic pain syndrome suggestive of deafferentation or central pain. Non-limiting examples of these syndromes are: * post-traumatic pain syndromes (e.g. plexopathies, radiation-induced injury) * postsurgical pain syndromes (e.g. phantom limb pain, anesthesia dolorosa) * postherpetic neuralgia * Central pain syndromes (e.g. post-stroke pain, multiple sclerosis pain, post-radiation pain) * Greater than 6 months of chronic neuropathic pain * Average pain intensity over the past 30 days reported as 6 or greater on a 0-10 numeric rating scale (NRS) * Multidisciplinary pain consensus review that establishes * Pain is refractory to medical management * Pain that is refractory to or unlikely to be altered by less invasive treatment and * Pain distribution either does not permit attempts at relief by a targeted nerve block (e.g., post-stroke pain) or such blocks have provided \<25% relief. * Medication doses currently stable (no active titration or drug trials in progress) in the 30 days prior to baseline (immediately pre-surgical) study visit * Ability to speak / read English * Capable of understanding and providing informed consent (verified if necessary by a standard tool such as the MacArthur Competency Assessment) * Women of childbearing age must be on regular use of an accepted contraceptive method(s). Exclusion Criteria: * Pregnancy, breastfeeding, or unwilling to maintain regular use of contraceptives. Patients who become pregnant after enrollment may be excluded from the study if study procedures may cause risk to the fetus. Patients who become pregnant prior to the surgical implantation will be excluded from the study. * 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. * Untreated or uncontrolled psychiatric illness (schizophrenia, bipolar disorder, obsessive-compulsive disorder), or personality disorders (e.g. borderline personality disorder) or other neuropsychiatric conditions that the evaluating clinician would recommend exclusion of the patient after neuropsychiatric evaluation. * History of seizure disorder and seizure within the last year. Participants with a remote history of epilepsy will need documentation from their neurologist for eligibility. * Suicide attempt within 12 months from baseline visit or imminent suicide risk in the judgment of study clinicians. * Modified Scale for Suicidal Ideation Score of greater than or equal to 21 * History of diagnosed substance use disorder in the past 3 years. Benzodiazepines and/or opioids prescribed by a physician with use as directed do not count for this criterion. Cannabis/cannabinoid products will not be considered an exclusion if used under the auspices of a state-sponsored medical cannabis program. * Major medical comorbidities increasing the risk of surgery including uncontrolled hypertension, severe diabetes, major organ system failure, need for chronic anticoagulation other than aspirin, active infection, immunocompromised state, or malignancy with \< 5 years life expectancy. * Inability to temporarily stop anticoagulation therapy (approximately 3 weeks total) 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. * MRI (done within one year of the baseline period) with significant abnormalities other than those associated with the neurological disorder causing chronic pain. * Implantable hardware not compatible with MRI or with the study or former metal worker that may pose risk from MRI. * Previous ablative intracranial surgery for the management of a central pain syndrome. * history of other neurosurgical procedures that may interfere with functioning of the device * Active, pending, or planned litigation or workman's compensation claim related to the pain/injury. Current receipt of disability benefits, without a dispute or litigation, is not an exclusion. * Requires ongoing or expected diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition * Allergies or known hypersensitivity to materials in the implanted system (i.e. titanium, polyurethane, silicone, polyetherimide, stainless steel). * Any other condition that, in the judgment of the PI or the Data Safety \& Monitoring Board, significantly increases risk of receiving an implanted neurostimulator. * Those who require ongoing monitoring of a disease state by MRI. * Inability to target the somatocognitive action network or cingulate opercular network on fMRI
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Minnesota
Minneapolis, Minnesota, 55455, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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