Stimulating the Social Brain

• ClinicalTrials.gov Identifier: NCT03374631
• Recruitment Status: Completed
• First Posted: December 15, 2017
• Last Update Posted: April 27, 2021
• Sponsor: The University of Texas at Dallas
• Information provided by (Responsible Party): Amy Pinkham, The University of Texas at Dallas

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Healthy Adults	Device: active anodal tDCS; Device: sham tDCS	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Participants will complete active and sham simulation sessions in a randomized, counterbalanced order approximately one week apart.
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Stimulating the Social Brain
• Actual Study Start Date: December 1, 2017
• Actual Primary Completion Date: October 1, 2020
• Actual Study Completion Date: October 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Active anodal tDCS; Active anodal tDCS followed by behavioral testing	Device: active anodal tDCS; active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation
Sham Comparator: Sham tDCS; Sham tDCS followed by behavioral testing	Device: sham tDCS; sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation

Outcome Measures

Primary Outcome Measures :

1. 20-item general paranoid ideation measure [ Time Frame: Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation ]
   Level of paranoid ideation will be assessed with the Paranoia Scale both before and after tDCS to assess changes related to tDCS.
2. 20-item social paranoia measure [ Time Frame: Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation ]
   Level of paranoid ideation will be assessed with the State Social Paranoia Scale both before and after tDCS to assess changes related to tDCS.

Secondary Outcome Measures :

1. Trustworthiness Task [ Time Frame: assessed 30 minutes after completion of the active/sham stimulation ]
   Participants will view images of others and rate their level of trustworthiness.
2. Penn Emotion Recognition Test [ Time Frame: assessed 30 minutes after completion of the active/sham stimulation ]
   Accuracy of facial emotion recognition
3. Achievement and Relationships Attribution Task [ Time Frame: assessed 30 minutes after completion of the active/sham stimulation ]
   How individuals explain everyday events.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

United States, Texas

The Unversity of Texas at Dallas

Richardson, Texas, United States, 75080

Sponsors and Collaborators

The University of Texas at Dallas

Investigators

• Principal Investigator: Amy Pinkham, PhD; The University of Texas at Dallas

More Information

• Responsible Party: Amy Pinkham, Associate Professor, The University of Texas at Dallas
• ClinicalTrials.gov Identifier: NCT03374631
• Other Study ID Numbers: 17-126
• First Posted: December 15, 2017
• Last Update Posted: April 27, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes