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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • PFM-guided cortical stimulation

    Device

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: PFM-guided cortical stimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility

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)

Time frame
12 months

Secondary outcomes

1

NRS Pain Scale

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)

Time frame
12 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: