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Pain Alleviation through Simultaneous Network Engagement (SENAP) Treatment

Study Aim

This early-stage study examines the feasibility of using the SENAP treatment to alleviate pain, specifically looking at the percentage of participants who undergo surgery, externalized stimulation testing, and IPG implantation.

What is being tested

PFM-guided cortical stimulation

Device

Who is being recruted

Nervous System Diseases+9

+ Neuralgia

+ Neurologic Manifestations

Over 22 Years

+35 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: July 2026

See protocol details

Summary

Principal SponsorUniversity of Minnesota

Study ContactMatthew Maple

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2026

Actual date on which the first participant was enrolled.

This clinical trial is exploring a new approach to treat central neuropathic pain, which is a type of chronic pain caused by damage to the nervous system. The study focuses on using a technique called PFM-guided cortical stimulation to see if it can reduce pain effectively. This research is particularly important for people who suffer from persistent pain that does not respond well to traditional pain management methods, and could potentially lead to improved treatments and better quality of life for these individuals. Participants in the trial will undergo a process where their brain is stimulated using a guided technique, aiming to alleviate their pain symptoms. The treatment involves carefully targeting specific areas of the brain, and the study will observe how acceptable this method is to participants and how well it works in reducing pain. Being in the early phase of testing, the main focus is on understanding if this method is safe and effective. There are no specific risks or benefits mentioned, but the study aims to gather important data to guide future research and treatment options.

Official TitleSimultaneous Engagement of Networks for Alleviating Pain (SENAP)

NCT07057206

Principal SponsorUniversity of Minnesota

Study ContactMatthew Maple

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 22 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nervous System DiseasesNeuralgiaNeurologic ManifestationsNeuromuscular DiseasesPainPain, PostoperativePathologic ProcessesPeripheral Nervous System DiseasesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeuralgia, Postherpetic

Criteria

16 inclusion criteria required to participate

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.

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19 exclusion criteria prevent from participating

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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Minnesota

Minneapolis, United StatesOpen University of Minnesota in Google Maps

Recruiting soonOne Study Center