Health Trials

LIFU for Chronic Pain and Generalized Anxiety Disorder

ConditionsChronic PainGeneralized Anxiety Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVirginia Polytechnic Institute and State University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Claustrophobia

Contraindications to MRI or CT

Active medical disorder with CNS effects

History of neurologic disorder

Trial design

Design model

Single group

Treatments tested in this trial

  • Low Intensity Focused Ultrasound

    Device

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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Low-intensity focused ultrasound for neuromodulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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.
3

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virginia Polytechnic Institute and State University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: