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Pain Alleviation through Simultaneous Network Engagement (SENAP) Treatment

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Study AimThis 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

Neuropathic Pain

+ Postherpetic Neuralgia
Over 22 Years
+35 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 2025

See protocol details

Summary

Principal SponsorUniversity of Minnesota
Study ContactMatthew Maple
Last updated: July 9, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2025Actual 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) 
Principal SponsorUniversity of Minnesota
Study ContactMatthew Maple
Last updated: July 9, 2025
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 22 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Neuropathic Pain
Postherpetic Neuralgia
Criteria
16 inclusion criteria required to participate
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)

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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

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)
Secondary Objectives

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)

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 MinnesotaMinneapolis, United StatesSee the location
Recruiting soonOne Study Center