Simultaneous Engagement of Networks for Alleviating Pain (SENAP)

NCT07057206 | Not Yet Recruiting Phase 1 FDA Device

• 1 other identifier: NSU-2025-33913
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Neuropathic Pain; Post-Traumatic Pain; Post-Surgical Pain; Postherpetic Neuralgia; Central Pain Syndrome; Chronic Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months

Secondary Outcomes (1)

• NRS Pain Scale

  12 months

Study Arms (1)

PFM-guided cortical stimulation

EXPERIMENTAL

Abbott Eterna IPG and Lamitrode 44 paddles with accessory extensions and clinical programmers

Device: PFM-guided cortical stimulation

Interventions

PFM-guided cortical stimulation DEVICE

Abbott Eterna IPG and Lamitrode 44 paddles with accessory extensions and clinical programmers

PFM-guided cortical stimulation

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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
• 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
• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Neuralgia; Neuralgia, Postherpetic; Pain, Postoperative

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• David Darrow, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Alexander Herman, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Maple

CONTACT

612-946-1424; maple036@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 9, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)