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Ultrasound Therapy

Non-invasive Ultrasound Brain Therapy for Chronic Pain (DBT Trial)

Phase 1 & 2

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stated willingness to comply with all study procedures and avoid changes to current treatments (medications, physical therapy, cognitive behavioral therapy) for the duration of the study

Age 18-65, any gender

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day at mri study visit

Awards & highlights

DBT Trial Summary

This trial will test a new non-invasive therapy for chronic pain, using MRI and pain rating scales to measure its effects.

Who is the study for?

This trial is for adults aged 18-65 with a primary diagnosis of generalized chronic pain or widespread chronic pain that's moderate-to-severe and lasting at least 2 months. Participants must be willing to maintain current treatments without changes and, if female and able to conceive, use effective contraception. Exclusions include serious brain injury, other neurologic disorders, certain medical conditions, pregnancy, breastfeeding, head/neck implants, MRI issues or recent brain stimulation.Check my eligibility

What is being tested?

The study tests a non-invasive deep brain therapy using low-intensity ultrasound (Diadem prototype) on individuals with chronic pain. It involves comparing real ('verum') stimulation against fake ('sham') in a blinded setup where neither the participants nor researchers know who receives which treatment until after the results are collected.See study design

What are the potential side effects?

Since this is a non-invasive procedure involving ultrasound waves directed at the brain through the skull there may be minimal side effects; however specific risks will depend on individual responses to ultrasound exposure but could potentially include discomfort at site of application or transient headaches.

DBT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to follow the study rules and not change my current treatments.

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I am between 18 and 65 years old.

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I have had chronic pain for at least 2 months.

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I have been diagnosed with widespread chronic pain.

DBT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day at mri study visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day at mri study visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day at mri study visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anxiety scale: subjective state

Depression scale: subjective state

Pain intensity: momentary change

+3 more

DBT Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active stimulationExperimental Treatment1 Intervention

Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in pain perception Intervention: Device: Diadem prototype

Group II: Sham stimulationPlacebo Group1 Intervention

Low-intensity transcranial focused ultrasound stimulation using unfocused wave Intervention: Device: Diadem prototype

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,100 Previous Clinical Trials

1,778,861 Total Patients Enrolled

27 Trials studying Chronic Pain

4,493 Patients Enrolled for Chronic Pain

Media Library

Deep Brain Therapy (Ultrasound Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05674903 — Phase 1 & 2

Chronic Pain Research Study Groups: Active stimulation, Sham stimulation

Chronic Pain Clinical Trial 2023: Deep Brain Therapy Highlights & Side Effects. Trial Name: NCT05674903 — Phase 1 & 2

Deep Brain Therapy (Ultrasound Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05674903 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment exclusively open to those under forty-five years old?

"The requisite age range for this trial is 18 to 65, with 33 trials available for younger participants and 346 studies open to seniors."

Answered by AI

Is participation in this clinical exploration still open?

"The details posted on clinicaltrials.gov indicate that this research study is not currently recruiting participants, having been first introduced on April 1st 2023 and last edited on January 4th of the same year. In spite of this, there are 392 other trials looking for patients at present time."

Answered by AI

Who qualifies to participate in this research endeavor?

"This clinical investigation is searching for 40 people suffering from chronic pain who are between 18 and 65 years old. To be eligible, applicants must meet the following criteria: age range of 18-65, any gender identity, a documented diagnosis of generalized or widespread chronic pain which has been present for at least 2 months; they should also signify their willingness to comply with study procedures without making changes to current treatments (medications/physical therapy/cognitive behavioural therapy) over the course of the trial. In addition, females that could potentially become pregnant need to provide proof of a negative pregnancy test within 1 month prior to baseline tests as well as agree to"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain

Jan Kubanek 2023. "Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05674903.

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