Stimulating the Social Brain

NCT03374631 | Completed Results FDA Device

• 1 other identifier: 17-126
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (2)

• Change in General Paranoid Ideation for Active vs. Sham Simulation

  Level of paranoid ideation will be assessed with the self-report Paranoia Scale (PS; Fenigstein \& Vanable, 1992) both before and after tDCS to assess changes related to tDCS. The PS is a self-report measure designed to assess sub-clinical paranoid thought. Scores range from 20-100 with higher scores indicating higher levels of paranoia. The amount of pre-post change (i.e. PS score assessed before stimulation minus score after stimulation) is the primary value of interest and will be compared between active and sham stimulation. Improvements in paranoia will be indicated by positive values.

  Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation

• Change in Change in Social Paranoia for Active vs. Sham Simulation

  Level of paranoid ideation will be assessed with the persecution subscale of the State Social Paranoia Scale (SSPS: Freeman et al., 2007) both before and after tDCS to assess changes related to tDCS. The SSPS is a psychometrically sound 20-item self- report measure assessing current levels of paranoid, positive, and neutral thinking about others. Ten items comprise the persecution subscale, and scores on this subscale range from 10-50 with higher scores indicating greater paranoia. The amount of pre-post change (i.e.SSPS score before stimulation minus SSPS score after stimulation) will be compared between active and sham stimulation. Positive values indicate reductions in paranoia after stimulation.

  Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation

Secondary Outcomes (2)

• Trustworthiness Task Score for Active vs. Sham Stimulation

  assessed 30 minutes after completion of the active/sham stimulation

• Penn Emotion Recognition Test for Active vs. Sham Stimulation

  assessed 30 minutes after completion of the active/sham stimulation

Study Arms (2)

Active anodal tDCS, Then Sham tDCS

EXPERIMENTAL

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

Device: active anodal tDCS; Device: sham tDCS

Sham tDCS, then Active anodal tDCS

SHAM COMPARATOR

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

Device: active anodal tDCS; Device: sham tDCS

Interventions

active anodal tDCS DEVICE

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

Active anodal tDCS, Then Sham tDCS; Sham tDCS, then Active anodal tDCS

sham tDCS DEVICE

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

Active anodal tDCS, Then Sham tDCS; Sham tDCS, then Active anodal tDCS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas at Dallas: lead

Study Sites (1)

The Unversity of Texas at Dallas

Richardson, Texas, 75080, United States

Location

Results Point of Contact

• Title: Dr. Amy Pinkham
• Organization: The University of Texas at Dallas

amy.pinkham@utdallas.edu

(972) 883-4462

Study Officials

• Amy Pinkham, PhD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will complete active and sham simulation sessions in a randomized, counterbalanced order approximately one week apart.

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 15, 2017
• Study Start: December 1, 2017
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: March 22, 2023
• Results First Posted: August 1, 2022

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)