LIFU for Chronic Pain and Generalized Anxiety Disorder

Accelerated Low-Intensity Focused Ultrasound (LIFU) for Chronic Pain and Generalized Anxiety Disorder: A Proof-of-Concept Case Series

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07686354

Enrollment

Registered

2026-07-07

Start date

2026-10-01

Completion date

2027-12-01

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Generalized Anxiety Disorder

Brief summary

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

Detailed description

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.

Interventions

DEVICELow Intensity Focused Ultrasound

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety - monitoring of possible symptoms	Throughout study participation at multiple time points, approximately 6 months.	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.
Changes in Chronic Pain - self report	Multiple timepoints throughout the 6 month experimental timeframe.	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).
Changes in Anxiety - self report	Throughout the experimental timeframe, approximately 6 months.	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).

Countries

United States

Contacts

CONTACTJessica Research Associate, MPH

jnw@vtc.vt.edu540-526-2261

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026