LIFU for Chronic Pain and Generalized Anxiety Disorder

N/ANot Yet RecruitingNCT07686354

Virginia Polytechnic Institute and State University10 enrolled

Overview

A proof of concept case study to investigate accelerated LIFU protocol in chronic pain and anxiety populations.

A single-arm, open label, 2 cohort (chronic pain/GAD) case study with extended (6 months) follow-up following accelerated low-intensity focused ultrasound for neuromodulation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Pain Generalized Anxiety Disorder

Interventions

Low Intensity Focused UltrasoundDEVICE

Low-Intensity Focused Ultrasound applied multiple times in a single study visit.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * GAD Symptoms - GAD-7 score \>= 10, OASIS score \>= 8, or PSWQ score \>= 45. OR Chronic pain symptoms - moderate to severe pain, present for at least 3 months. Exclusion Criteria: * Claustrophobia * Contraindications to MRI or CT * Active medical disorder with CNS effects * History of neurologic disorder * History of head injury with LOC \> 10 minutes * Active drug or alcohol dependence

Locations (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, United States

Outcomes

Primary Outcomes

Safety - monitoring of possible symptoms

Symptom monitoring before and after LIFU applications and throughout 6 months of follow-up. Each symptom is presented with a likert scale (absent, mild, moderate, severe) - along with a free response option for any symptoms not included in the list.

Time frame: Throughout study participation at multiple time points, approximately 6 months.

Changes in Chronic Pain - self report

Participants will complete the Brief Pain Inventory (BPI) at multiple time points throughout the 6 month period. This questionnaire asks participants to rate their pain on a 10 point scale (10 being the most pain).

Time frame: Multiple timepoints throughout the 6 month experimental timeframe.

Changes in Anxiety - self report

Participants will complete the Beck Anxiety Inventory (BAI) at multiple time points before and after LIFU application to track changes in anxiety throughout the 6 month timeframe. The BAI probes different symptoms of anxiety and participants rate it on a likert scale (not at all, mildly, moderately, or severely).

Time frame: Throughout the experimental timeframe, approximately 6 months.

Central Contacts

Jessica Research Associate, MPH

CONTACT

540-526-2261 jnw@vtc.vt.edu

Data from ClinicalTrials.gov

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