Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Not yet recruitingPhase 1NCT07057206
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This trial is investigating the acceptability and efficacy of PFM-guided cortical stimulation for the treatment of central neuropathic pain.
Study details
- Official title
- Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
- Conditions
- Interventions
- Device: PFM-guided cortical stimulation
- Sponsor
- University of Minnesota
- Start date
- 2026-11-01
- Primary completion
- 2030-12
- Sex
- All
- Age range
- from 22 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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) * Women of childbearing age must be on regular use of an accepted contraceptive method(s). 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 …
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07057206