Simultaneous Engagement of Networks for Alleviating Pain (SENAP)

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age22+
SponsorUniversity of Minnesota

About this trial

This trial is investigating the acceptability and efficacy of PFM-guided cortical stimulation for the treatment of central neuropathic pain.

Eligibility criteria

Qualifiers

Age ≥ 22 years

post-traumatic pain syndromes (e.g. plexopathies, radiation-induced injury)

postsurgical pain syndromes (e.g. phantom limb pain, anesthesia dolorosa)

postherpetic neuralgia

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • PFM-guided cortical stimulation

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators