Clinical trial NCT03374631: Stimulating the Social Brain
Official title: Stimulating the Social Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will complete active and sham simulation sessions in a randomized, counterbalanced order approximately one week apart.
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates whether the way in which individuals process social stimuli can be altered, and specifically, whether feelings of paranoia and suspiciousness can be reduced by stimulating the brain's regulatory regions via transcranial Direct Current Stimulation (tDCS).

Detailed description: Although paranoid ideation is typically associated with severe mental illnesses such as schizophrenia or bipolar disorder, 10-15% of individuals in the general population report experiencing paranoid thoughts on a regular basis. These individuals who are high in sub-clinical paranoia can show impaired work and social functioning as compared to individuals low in sub-clinical paranoia. The wide spread prevalence and negative functional impact of heightened paranoia reinforces the need to develop interventions that may help to reduce problematic patterns of paranoid thinking in both healthy individuals and those with mental illness.

Transcranial Direct Current Stimulation (tDCS) is a form of noninvasive neurostimulation which has been proposed as a therapeutic procedure in numerous psychiatric conditions. TDCS therefore may be a promising therapeutic technique for reducing symptoms of psychosis, and specifically paranoia. This study will compare experiences of paranoid ideation in individuals who are high in sub-clinical paranoia across two conditions: active anodal tDCS and sham tDCS.

Eligibility criteria: Inclusion Criteria:

* between the ages of 18 ad 35
* previous classification as being high in sub-clinical paranoia

Exclusion Criteria:

* diagnosis of mental illness
* use of psychotropic medication
* Presence or history of medical, cardiac, or neurological disorders that may affect brain function (e.g., cardiac disease, endocrine disorders, renal disease, pulmonary disease, history of seizures or head trauma with unconsciousness for a period of 15 minutes or greater or CNS tumors)
* Presence of sensory limitation including visual (e.g., blindness, glaucoma, vision uncorrectable to 20/40) or hearing (e.g. hearing loss) impairments that interfere with assessment
* Not proficient in English
* Contraindications for tDCS (e.g., pregnancy or implanted devices such as pace maker)

Primary outcomes:
measure: Change in General Paranoid Ideation for Active vs. Sham Simulation
timeFrame: Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation
measure: Change in Change in Social Paranoia for Active vs. Sham Simulation
timeFrame: Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation
Secondary outcomes:
measure: Trustworthiness Task Score for Active vs. Sham Stimulation
timeFrame: assessed 30 minutes after completion of the active/sham stimulation
measure: Penn Emotion Recognition Test for Active vs. Sham Stimulation
timeFrame: assessed 30 minutes after completion of the active/sham stimulation
Other outcomes:
Locations:
city: Richardson
country: United States
facility: The Unversity of Texas at Dallas
state: Texas
Study officials:
affiliation: The University of Texas at Dallas
name: Amy Pinkham, PhD
role: PRINCIPAL_INVESTIGATOR
References: