Clinical trial NCT04485208: Focused Ultrasound for the Treatment of Neuropathic Pain
Official title: Open Label Study for the Use of Focused Transcranial Ultrasound for Treatment of Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Neuropathic Pain
Lead sponsor: Neurological Associates of West Los Angeles
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: Baseline
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline
Secondary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: Post Final Treatment (8 weeks from baseline)
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Post Final Treatment (8 weeks from baseline)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Post Final Treatment (8 weeks from baseline)
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Neurological Associates of West LA
state: California
Study officials:
affiliation: Neurological Associates of West Los Angeles
name: Sheldon Jordan, MD
role: PRINCIPAL_INVESTIGATOR
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