Activating and Identifying Neural Responses to Social Rejection: a Combined tDCS and fMRI Study

NCT02739789 | Completed Results

• 1 other identifier: SBU Psychiatry Pilot
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This research study identifies neural pathways regulating negative moods during rejection by combining transcranial direct current stimulation (tDCS) and fMRI in a sample of healthy controls.

Conditions

Healthy

Keywords

tDCS rejection affect mood fMRI

Outcome Measures

Primary Outcomes (4)

• Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units)

  Images from fMRI scans for each participant are preprocessed (e.g., realigned, normalized, smoothed). Changes in BOLD signal are modeled for rejection and acceptance vs neutral blocks, and contrast images are created. These contrast images are used to compare tDCS vs sham for each subject in a within-subjects analysis. BOLD responses are reported as arbitrary units (i.e., change from sham stimulation). Regions of interest include left and right ventrolateral prefrontal cortex (VLPFC), left and right nucleus accumbens (NAcc), left and right amygdala (Amyg), left and right anterior insula (AI), left and right dorsal anterior cingulate cortex (dACC).

  1-3 weeks

• Change in Positive and Negative Affect Scale (During fMRI)

  Change in emotion will be measured on the "Positive and Negative Affect Scale." During Rejection, Acceptance, and Neutral conditions, participants rate how much they feel "sad," "rejected," "happy," and "accepted" on a visual analog scale from "not at all" (minimum score of "0") to "extremely" (maximum score of "100"). Scores for "sad" were averaged with "rejected," and scores for "happy" were averaged with "accepted." The averaged scores during Neutral were subtracted from Rejection and Acceptance to derive the outcome measures. Higher outcome measure score means that the participant felt more of that particular emotion during a particular condition (minus neutral). Thus, a higher score for "happy and accepted" during the Acceptance-Neutral condition means a better outcome. Similarly, a lower score for "happy and accepted' during Rejection-Neutral condition means a worse outcome.

  1-3 weeks

• Change in the Single-item Self-Esteem Scale (During fMRI)

  Change in self-esteem will be measured on the "Single-item Self-Esteem Scale." During Rejection, Acceptance, and Neutral conditions, participants respond to the item "I have high self-esteem" on a visual analog scale from "not at all true of me" (minimum score of "0") to "very true of me" (maximum score of "100"). Scores during Neutral were subtracted from Rejection and Acceptance to derive the outcome measures. Higher outcome measure score means that the participant had more self-esteem, and thus a better outcome, during a particular condition (minus neutral).

  1-3 weeks

• Change in Desire for Social Interaction Scale (During fMRI)

  Change in Desire for Social Interaction will be measured on the "Desire for Social Interaction Scale." During Rejection, Acceptance, and Neutral conditions, participants respond to four items measuring desire for social interaction (e.g., "I would enjoy social interaction right now") on a visual analog scale from "very slightly or not at all" (minimum score of "0") to "extremely" (maximum score of "100"). Scores during Neutral were subtracted from Rejection and Acceptance to derive the outcome measures. Higher outcome measure score means that the participant had greater desire for social interaction, and thus a better outcome, during a particular condition (minus neutral).

  1-3 weeks

Study Arms (2)

Sham tDCS

SHAM COMPARATOR

tDCS stimulation will be administered over the brain area of interest, but will be shorter in duration than the "active" treatment

Device: Sham tDCS

Active tDCS

ACTIVE COMPARATOR

tDCS stimulation will be administered over the brain area of interest

Device: tDCS

Interventions

tDCS DEVICE

tDCS

Active tDCS

Sham tDCS DEVICE

Sham tDCS

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or females between 18 and 25 years old
• No diagnosis on Axis I by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV. No current, or within the past 5 years.
• Not currently in a romantic relationship
• Ability to understand and follow instructions and oriented to name, time, and place.
• No additional neurologic or psychiatric disorders
• No current use of psychotropic drugs or during past 3 months (except marijuana and alcohol)
• No current use of marijuana or during past 3 weeks
• Not currently abusing alcohol
• No history of alcohol or drug dependence within past 5 years
• A negative urine pregnancy and toxicology screen. Verbal affirmation will be obtained (i.e., "not pregnant" and "not currently using psychotropic drugs or during the past 3 months") during the Screening Visit (Day 1). Urine screen will be obtained on Days 2 and 3. If subject reports that there is a "possibility that she is pregnant" on Day 1 (Screening Visit) a urine pregnancy screen will be performed on that day.
• (Women): If stopped or started oral contraceptives recently, at least 60 days on/off oral contraceptives.

You may not qualify if:

• Left-handed or ambidextrous
• Metallic dental implants
• Metallic objects in the brain/skull
• Medical device implants
• Implanted electronic devices
• History of seizures
• History of strokes
• Unexplained loss of consciousness
• Frequent or severe headaches or neck pain
• Clinically significant, uncontrolled liver, kidney, cardiac, or pulmonary disease
• Terminal medical diagnosis consistent with survival \< 1 year
• Pregnancy; childbirth or miscarriage within 6 months, breastfeeding within 6 months of recruitment
• Serious mental impairment. Mini mental state exam of \< 23/30
• Chronic skin disease
• Previous experience with transcranial direct current stimulation (tDCS)

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794-8101, United States

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. David Hsu, Assistant Professor of Psychiatry
• Organization: Stony Brook University

david.hsu@stonybrookmedicine.edu

(631) 638-1522

Study Officials

• David T Hsu, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: within-subjects crossover design

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 15, 2016
• Study Start: February 14, 2018
• Primary Completion: October 16, 2018
• Study Completion: October 16, 2018
• Last Updated: July 8, 2020
• Results First Posted: July 8, 2020

Record last verified: 2020-06

Locations

US (1)