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
1 other identifier
interventional
10
1 country
1
Brief Summary
A proof of concept case study to investigate accelerated LIFU protocol in chronic pain and anxiety populations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-pain
Started Aug 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2026
CompletedFirst Posted
Study publicly available on registry
July 7, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
July 7, 2026
June 1, 2026
1 year
June 30, 2026
June 30, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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).
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).
Throughout the experimental timeframe, approximately 6 months.
Study Arms (1)
Low-intensity focused ultrasound for neuromodulation
EXPERIMENTALAccelerated (repeat) LIFU application for neuromodulation
Interventions
Low-Intensity Focused Ultrasound applied multiple times in a single study visit.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 30, 2026
First Posted
July 7, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
July 7, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share