Focused Ultrasound for the Treatment of Neuropathic Pain

Neurological Associates of West Los Angeles

Status: Invitation-only

Conditions: Neuropathic Pain

Treatments: Device: Focused Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04485208

fUS_NeuropathicPain

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Active

Experimental group

Description:

Patients will undergo ten to thirty minutes of transcranial ultrasound treatment. The sonification device will be aimed at the thalamus. Targeting will include reference to scalp fiducials based on the obtained MRI; confirmation of target accuracy will either be obtained by Doppler waveform confirmation or optical tracking technology which co-registers patient neuroimaging with real space.

Treatment:

Device: Focused Ultrasound