Low-Intensity Focused Ultrasound and the Complex Patient
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVirginia Polytechnic Institute and State University
About this trial
Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females aged 18-65 years
Current diagnosis of Chronic Back Pain as defined by pain duration of at least three months, with back pain being an ongoing problem for at least half the days of the last six months.
Have evidence of central sensitization (CS) as measured by the Widespread Pain/Symptom Severity Index (WPSSI) with a score of Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI = 3-6 and SS ≥ 9.
Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for DSM-5.
Disqualifiers
Evidence of neuropathic pain
Previous spine surgery
Current substance use disorder other than OUD or tobacco use disorder
Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
Trial design
Design model
Single group
Treatments tested in this trial
Low-Intensity Focused Ultrasound
DeviceA noninvasive brain stimulation device using low-intensity focused ultrasound (LIFU) - ultrasound will be used to test whether noninvasive brain stimulation can effect pain, craving, and anxiety.
Low-Intensity Focused Ultrasound - sham
DeviceA sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Pain, Craving, and Anxiety measuresExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events via a neurological examination
Any abnormal finding from the neurological exam will be recorded as an adverse event (AE) and tabulated with the side effects and tolerability data.
Time frame
Assessed per participant, over the course of participation - an average of 4 weeks2
Incidence of Treatment-Emergent Adverse Events via a side effects questionnaire
Side effects and reported severity will be tabulated and summarized on a 5 point likert scale.
Time frame
Assessed per participant, over the course of participation - an average of 4 weeks3
Changes in Heart Rate (HR)
changes in HR compared pre/post LIFU and at follow up
Time frame
Assessed per participant, over the course of participation - an average of 4 weeks4
Changes in Respiration Rate (RR)
changes in RR compared pre/post LIFU and at follow up
Time frame
Assessed per participant, over the course of participation - an average of 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Virginia Polytechnic Institute and State University
Lead sponsor
Salem VA Medical Center
Collaborator
Washington DC VA Medical Center
Collaborator
Source ClinicalTrials.gov