Stimulating the Social Brain

NCT ID: NCT03374631

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2020-10-01

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.

Conditions

Healthy Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Active anodal tDCS, Then Sham tDCS

Active anodal tDCS followed by behavioral testing; one week later, sham tDCS followed by behavioral testing

Group Type: EXPERIMENTAL

active anodal tDCS

Intervention Type: DEVICE

active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation

sham tDCS

Intervention Type: DEVICE

sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation

Sham tDCS, then Active anodal tDCS

Sham tDCS followed by behavioral testing; one week later, active anodal tDCS followed by behavioral testing.

Group Type: SHAM_COMPARATOR

active anodal tDCS

Intervention Type: DEVICE

active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation

sham tDCS

Intervention Type: DEVICE

sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation

Interventions

active anodal tDCS

active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation

Intervention Type: DEVICE

sham tDCS

sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas at Dallas

OTHER

Sponsor Role: lead

Responsible Party

Amy Pinkham, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Pinkham, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Dallas

Locations

The Unversity of Texas at Dallas

Richardson, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-126

Identifier Type: -

Identifier Source: org_study_id