Focused Ultrasound for the Treatment of Neuropathic Pain

Open Label Study for the Use of Focused Transcranial Ultrasound for Treatment of Neuropathic Pain

A possible treatment approach for neuropathic pain would employ a process designed to promote healthier function of the ventral posteromedial (VPM) and ventral posterolateral (VPL) thalamic nuclei. This study is designed to employ focused ultrasound technology to target the VPM and VPL thalamus among participants with ongoing neuropathic pain syndromes to evaluate for tolerability and early efficacy.

The present open-label study is being undertaken to evaluate focused transcranial ultrasound therapy as an intervention for patients with neuropathic pain. The subjects in this research study will be recruited through medical practice. Participants who are enrolled will undergo 8 consecutive weekly ultrasound sessions. Targeting for treatment will be based on patient MRI scans using stereotaxic techniques.

Inclusion Criteria:

• History of neuropathic pain (onset, location, intensity, duration, quality, aggravating factors)
• Confirmation of nervous system injury through imaging or negative or positive sensory signs confined to the corresponding bodily area
• Failure from at least 3 pharmacological treatments (e.g., antidepressants, anticonvulsants, opioids)
• At least 18 years of age

Exclusion Criteria:

• Subjects unable to give informed consent
• Subjects who would not be able to lay down without excessive movement in a calm environment
• Pregnancy, women who may become pregnant or are breastfeeding
• Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)