Neuropathic PainPhase 1NCT07057206
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
A Phase 1 study testing PFM-guided cortical stimulation in people with Neuropathic Pain and Postherpetic Neuralgia, run by University of Minnesota at 1 site in United States.
Trial summary
This trial is investigating the acceptability and efficacy of PFM-guided cortical stimulation for the treatment of central neuropathic pain. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Neuropathic Pain, Postherpetic Neuralgia
- What is being tested?
- PFM-guided cortical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to Dec 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Melanie G Keiser contact
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
Matthew Maple, maple036@umn.edu
About this study
This trial is investigating the acceptability and efficacy of PFM-guided cortical stimulation for the treatment of central neuropathic pain.
- Conditions
- Neuropathic Pain, Postherpetic Neuralgia
- Being tested
- PFM-guided cortical stimulation
- Keywords
- Neuropathic Pain, Post-Traumatic Pain, Post-Surgical Pain, Postherpetic Neuralgia, Central Pain Syndrome, Chronic Neuropathic Pain
- Medical subject headings
- Neuralgia, Neuralgia, Postherpetic, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFM-guided cortical stimulationDevice
Abbott Eterna IPG and Lamitrode 44 paddles with accessory extensions and clinical programmers
| Study group | Role | What they receive |
|---|---|---|
| PFM-guided cortical stimulation | Experimental | Abbott Eterna IPG and Lamitrode 44 paddles with accessory extensions and clinical programmers Receives: Device: PFM-guided cortical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Percentage of participants enrolled in the study who then undergo surgery and undergo externalized stimulation testing followed by implantation of the implantable pulse generator (IPG)
Measured: 12 months
Secondary outcomes (1)
NRS Pain Scale
Difference in numerical pain rating scale (NRS) between the best stimulation (sample of 5) and sham stimulation (sample of 5). Min-Max values: (0-10) where lower scores indicate a better outcome (more pain reduction)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
1 Nov 2026Dec 2030
- First posted9 Jul 2025
- Study start1 Nov 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Darrow, MD, Principal investigator, University of MinnesotaAlexander Herman, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057206
- Sponsor's protocol ID
- NSU-2025-33913
- Status last verified
- Jul 2026
- First submitted
- 13 Jun 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No