๐๏ธ Verified NIH Record โข Updated 2026-07-22
Simultaneous Engagement of Networks for Alleviating Pain (SENAP) (NCT07057206)
๐ก Not Yet Recruiting Phase1 โ๏ธ Medical Device Protocol Sponsor: University of Minnesota
๐ฉบ Plain-English Summary (8th-Grade Level)
This trial is investigating the acceptability and efficacy of PFM-guided cortical stimulation for the treatment of central neuropathic pain.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (16 items) and avoid the listed exclusions (20 items).
Location: University of Minnesota โ Minneapolis, Minnesota
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (1 Sites)
- University of Minnesota โ Minneapolis, Minnesota
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.