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Clinical Trials/NCT05986019
NCT05986019
Completed
Not Applicable

Evaluating the Effects of Transcranial Focused Ultrasound (tFUS) on Fronto-striatal Resting State Functional Connectivity in Healthy Individuals

Medical University of South Carolina1 site in 1 country10 target enrollmentJuly 25, 2023
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Medical University of South Carolina
Enrollment
10
Locations
1
Primary Endpoint
Resting State Functional Connectivity
Status
Completed
Last Updated
last year

Overview

Brief Summary

Aim: Evaluate whether sonicating the Nucleus Accumbens (NAc) with transcranial focused ultrasound modifies functional connectivity between the NAc and the prefrontal cortex (PFC).

In this single visit, open-label pilot trial, we plan to evaluate whether transcranial focused ultrasound (tFUS), delivered to the nucleus accumbens (NAc) within the magnetic resonance imaging (MRI) scanner will impact resting state functional connectivity between the NAc and functionally connected brain regions like the prefrontal cortex (PFC) and the anterior cingulate cortex (ACC) in up to 10 healthy individuals.

HYPOTHESIS : tFUS will reduce prefrontal cortex (PFC)-NAc functional connectivity, in healthy individuals. We will investigate this hypothesis by administering tFUS within to MRI scanner to healthy individuals and conduct resting state functional neuroimaging before- and after the tFUS stimulation.

Registry
clinicaltrials.gov
Start Date
July 25, 2023
End Date
June 27, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 18-65
  • Have the capacity and ability to provide one's own consent and sign the informed consent document

Exclusion Criteria

  • Contraindicated for MRI.
  • Any current or recent untreated medical, neurological, or psychiatric conditions
  • Metal implant devices in the head, heart, or neck.
  • History of brain surgery.
  • History of myocardial infarction or arrhythmia, bradycardia.
  • Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium).
  • Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury.
  • Individuals suffering from frequent/severe headaches.
  • Individuals with a reported history of psychosis or mania, or individuals who are actively manic or psychotic.
  • Regular or recent pain medication use

Outcomes

Primary Outcomes

Resting State Functional Connectivity

Time Frame: 24 minutes

The main outcomes of this study are brain imaging related. Using a neuroimaging technique called resting state functional connectivity, which is a statistical dependence between time series of electro-physiological activity and (de)oxygenated blood levels in distinct regions of the brain. Modularity is measured on a -1 to 1 scale, with higher scores indicating stronger community structure, or a stronger tendency of clusters of brain regions to separate into distinct, highly interconnected networks with sparse connections across networks. The optimal modularity value depends on the context. For example, during complex tasks lower modularity is better, while during basic, automatic tasks higher modularity is better.

Study Sites (1)

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