Stimulating the Social Brain

• Sponsor: The University of Texas at Dallas (Other)
• Overall Status: Completed
• CT.gov ID: NCT03374631
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 34
• Patients Per Site Per Month: 1.2

Study Details

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	N/A

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
• 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.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: Dec 1, 2017
• Actual Primary Completion Date: Oct 1, 2020
• Actual Study Completion Date: Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active anodal tDCS, Then Sham tDCS Active anodal tDCS followed by behavioral testing; one week later, sham tDCS followed by behavioral testing	Device: active anodal tDCS; active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation; Device: sham tDCS; sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation
Sham Comparator: Sham tDCS, then Active anodal tDCS Sham tDCS followed by behavioral testing; one week later, 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; Device: sham tDCS; sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation

Outcome Measures

Primary Outcome Measures

1. Change in General Paranoid Ideation for Active vs. Sham Simulation [Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation]

   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.

2. Change in Change in Social Paranoia for Active vs. Sham Simulation [Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation]

   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.

Secondary Outcome Measures

1. Change in Trustworthiness Task Score for Active vs. Sham Stimulation [assessed 30 minutes after completion of the active/sham stimulation]

   Participants will complete the Trustworthiness Task (Adolphs, Tranel, & Damasio, 1998), which asks individuals to view 42 images of others and rate their level of trustworthiness on a scale from -3 to 3. Scores range from -126 to 126. Higher scores indicate greater perceptions of trustworthiness. Mean ratings following each stimulation type (active vs. sham) are calculated.

2. Change in Penn Emotion Recognition Test for Active vs. Sham Stimulation [assessed 30 minutes after completion of the active/sham stimulation]

   The Emotion Recognition 40 (ER-40; Kohler, Turner, Bilker, Brinsinger, Siegel, Kanes... Gur, 2003) is a standardized, computer administered measure of facial affect recognition ability. It includes 40 color photographs of faces expressing 4 basic emotions (i.e. happiness, sadness, anger or fear) and neutral expressions. Participants view one face at a time and are asked to choose the correct emotion for each face. Scores range from 0-40 with higher scores indicating better accuracy. Mean performance following each stimulation type (active vs. sham) are calculated.

Eligibility Criteria

Criteria

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

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 2, 2017

More Information

Publications

None provided.

• Responsible Party: Amy Pinkham, PhD, Associate Professor, The University of Texas at Dallas
• ClinicalTrials.gov Identifier: NCT03374631
• Other Study ID Numbers: 17-126
• First Posted: Dec 15, 2017
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

Participant Flow

Arm/Group Title	Active Anodal tDCS, Then Sham tDCS	Sham tDCS, Then Active Anodal tDCS
Arm/Group Description	Active anodal tDCS followed by behavioral testing; one week later, sham tDCS followed by behavioral testing active anodal tDCS: active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation sham tDCS: sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation	Sham tDCS followed by behavioral testing; one week later, active anodal tDCS followed by behavioral testing. active anodal tDCS: active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation sham tDCS: sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation
Period Title: First Intervention (20 Minutes)
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0
Period Title: First Intervention (20 Minutes)
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0
Period Title: First Intervention (20 Minutes)
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Active Anodal tDCS, Then Sham tDCS	Sham tDCS, Then Active Anodal tDCS	Total
Arm/Group Description	Active anodal tDCS followed by behavioral testing; one week later, sham tDCS followed by behavioral testing active anodal tDCS: active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation sham tDCS: sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation	Sham tDCS followed by behavioral testing; one week later, active anodal tDCS followed by behavioral testing. active anodal tDCS: active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation sham tDCS: sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation	Total of all reporting groups
Overall Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	20.7 (2.30)	19.6 (1.98)	20.15 (2.19)
Sex: Female, Male (Count of Participants)
Female	12 60%	13 65%	25 62.5%
Male	8 40%	7 35%	15 37.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 25%	6 30%	11 27.5%
Not Hispanic or Latino	15 75%	14 70%	29 72.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	11 55%	10 50%	21 52.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 5%	0 0%	1 2.5%
White	6 30%	7 35%	13 32.5%
More than one race	2 10%	3 15%	5 12.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Change in General Paranoid Ideation for Active vs. Sham Simulation
Description	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.
Time Frame	Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Stimulation	Sham Stimulation
Arm/Group Description	20 minutes of Active anodal tDCS followed by behavioral testing	20 minutes of Sham tDCS followed by behavioral testing
Measure Participants	40	40
Mean (Standard Deviation) [score on a scale]	1.60 (3.11)	.73 (3.80)

2. Primary Outcome

Title	Change in Change in Social Paranoia for Active vs. Sham Simulation
Description	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.
Time Frame	Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Anodal Stimulation	Sham tDCS
Arm/Group Description	20 minutes of Active anodal tDCS followed by behavioral testing	20 minutes of Sham tDCS followed by behavioral testing
Measure Participants	40	40
Mean (Standard Deviation) [score on a scale]	.75 (2.52)	.93 (2.34)

3. Secondary Outcome

Title	Change in Trustworthiness Task Score for Active vs. Sham Stimulation
Description	Participants will complete the Trustworthiness Task (Adolphs, Tranel, & Damasio, 1998), which asks individuals to view 42 images of others and rate their level of trustworthiness on a scale from -3 to 3. Scores range from -126 to 126. Higher scores indicate greater perceptions of trustworthiness. Mean ratings following each stimulation type (active vs. sham) are calculated.
Time Frame	assessed 30 minutes after completion of the active/sham stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Anodal tDCS	Sham tDCS
Arm/Group Description	20 minutes of Active anodal tDCS followed by behavioral testing	20 minutes of Sham tDCS followed by behavioral testing
Measure Participants	40	40
Mean (Standard Deviation) [score on a scale]	-.14 (.64)	-.14 (.60)

4. Secondary Outcome

Title	Change in Penn Emotion Recognition Test for Active vs. Sham Stimulation
Description	The Emotion Recognition 40 (ER-40; Kohler, Turner, Bilker, Brinsinger, Siegel, Kanes... Gur, 2003) is a standardized, computer administered measure of facial affect recognition ability. It includes 40 color photographs of faces expressing 4 basic emotions (i.e. happiness, sadness, anger or fear) and neutral expressions. Participants view one face at a time and are asked to choose the correct emotion for each face. Scores range from 0-40 with higher scores indicating better accuracy. Mean performance following each stimulation type (active vs. sham) are calculated.
Time Frame	assessed 30 minutes after completion of the active/sham stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Anodal tDCS	Sham tDCS
Arm/Group Description	20 minutes of Active anodal tDCS followed by behavioral testing	20 minutes of Sham tDCS followed by behavioral testing
Measure Participants	40	40
Mean (Standard Deviation) [score on a scale]	35.05 (2.39)	35.33 (2.31)

Adverse Events

Time Frame	10 days for each arm.
Arm/Group Title	Active Anodal tDCS		Sham tDCS
Arm/Group Description	20 minutes of Active anodal tDCS followed by behavioral testing		20 minutes of Sham tDCS followed by behavioral testing
All Cause Mortality
	Active Anodal tDCS		Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Serious Adverse Events
	Active Anodal tDCS		Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Active Anodal tDCS		Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.