Low-Intensity Focused Ultrasound (LIFU) Neuromodulation of the Ventral Striatum in Cocaine Use Disorder

Summary

This Phase 1 study will test whether Low-Intensity Focused Ultrasound (LIFU), a non-invasive form of brain stimulation, is safe and feasible to deliver to the ventral striatum in adults with Cocaine Use Disorder (CUD), and whether it produces measurable changes in brain activity. Twenty participants will be enrolled at the University of Pennsylvania. This study is apart of the HEAL Initiative (https://www.nih.gov/heal) This study does not test whether LIFU can reduce cocaine use; it is designed only to evaluate the safety, feasibility, and neural effects of the intervention.

Eligibility

Age range

18–65 years

Sex

All

Healthy volunteers

No

Interventions

• Device
  Low Intensity Focused Ultrasound

  This study utilizes a single-element ultrasound transducer (Sonic Concepts) positioned over the head of each participant. Transducer alignment with the target brain region is maintained throughout the session using a neuronavigation tracking system (BrainSight) referenced to reflective markers on the participant's head. Participants wear headphones playing white noise throughout the session, identical for both active and sham conditions, to mask any procedure-related auditory cues. LIFU (or sham) is applied to both sides of the brain targeting the same area of the brain (Ventral Striatum). The device has been determined by the study's regulatory reviewers to pose non-significant risk and is not FDA-approved for any indication; its use in this study is investigational.

Location