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 volunteersQualifiers
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
Single group
Treatments tested in this trial
PFM-guided cortical stimulation
DeviceAbbott Eterna IPG and Lamitrode 44 paddles with accessory extensions and clinical programmers
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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)
Sponsors and contacts
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