LIFU for Chronic Pain and Generalized Anxiety Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low Intensity Focused Ultrasound.
- Who it may be relevant to
- Registry conditions: Chronic Pain, Generalized Anxiety Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Accelerated Low-Intensity Focused Ultrasound (LIFU) for Chronic Pain and Generalized Anxiety Disorder: A Proof-of-Concept Case Series
Overview
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
- Device Low Intensity Focused Ultrasound
Low-Intensity Focused Ultrasound applied multiple times in a single study visit.
Primary outcome measures
- Safety - monitoring of possible symptoms [Time frame: Throughout study participation at multiple time points, approximately 6 months.]
- Changes in Chronic Pain - self report [Time frame: Multiple timepoints throughout the 6 month experimental timeframe.]
- Changes in Anxiety - self report [Time frame: Throughout the experimental timeframe, approximately 6 months.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Fralin Biomedical Research Institute at VTC — Roanoke
Identifiers
NCT: NCT07686354 · 26-649