RecruitingNot ApplicableNCT04379115

Optimization of NIBS for Treatment of Addiction

Optimization of Non-Invasive Brain Stimulation for Treatment of Addiction


Sponsor

Case Western Reserve University

Enrollment

126 participants

Start Date

Apr 4, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the effects of transcranial Direct Current Stimulation (tDCS) applied in conjunction with Transcranial Ultrasound (TUS) for the treatment of addiction in opiate use disorder with chronic pain. The investigators hypothesize that there will be a decrease in drug use and improved psychosocial assessments with active stimulation, when compared to sham stimulation.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Active Comparator: Active tDCS + Active TUS and a medical device called Sham Comparator: Sham tDCS + Sham TUS for people with chronic pain and opioid-use disorder. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive Comparator: Active tDCS + Active TUS

Device: Active comparator device: Active transcranial Direct Current Stimulation (tDCS). Subjects will receive 20 minutes of active tDCS. During each Active stimulation session, stimulation will be applied for the full 20 minutes. Device: Active comparator device: Active Transcranial Ultrasound (TUS). Subjects will receive 20 minutes of active Transcranial Ultrasound (TUS). During active stimulation the (TUS) will be active for the full 20 minutes.

DEVICESham Comparator: Sham tDCS + Sham TUS

Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of sham tDCS. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of sham TUS. During sham stimulation the ultrasound will not be active for the full 20 minutes.


Locations(3)

University of Illinois Health/ University of Illinois at Chicago

Hinsdale, Illinois, United States

Spaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center

Cambridge, Massachusetts, United States

University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit

Cleveland, Ohio, United States

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NCT04379115


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