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

NCT ID: NCT02739789

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-14
• Study Completion Date: 2018-10-16

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.

Detailed Description

Aim 1: To test the behavioral effects of tDCS during social rejection. The first step will be to obtain behavioral effects of transcranial direct current stimulation (tDCS) during social rejection without functional magnetic resonance imaging (fMRI). Whereas previous studies used "Cyberball" (a computerized ball-tossing game that simulates social exclusion), we will use the Social Feedback Task. This task was created by Dr. Hsu to be more ethologically-relevant, has been shown to sustain negative moods during rejection and activates the right ventral lateral prefrontal cortex (rVLPFC) (preliminary fMRI data from 50 healthy controls in Dr. Hsu's previous study). Anodal tDCS will be applied over the right or left VLPFC to measure changes in mood during rejection and neutral conditions. Depending on results, alternate regions in separate subjects may also be stimulated: dorsolateral prefrontal cortex, insula, anterior cingulate cortex, pre-supplementary, and supplementary motor area [all regions may be right or left hemisphere]. All of these regions have been shown to be involved in emotion regulation. Questionnaires will be given before, during, and after the task to assess cognitive and emotional states.

Aim 2: To identify neural pathways regulating negative moods during social rejection, using tDCS for activation and fMRI for assessment. Using a cross-over, sham-controlled design similar to previous tDCS+fMRI studies, we will measure the effects of anodal tDCS over the right or left VLPFC on neural activity and negative mood during rejection and neutral conditions. Alternate regions in separate subjects may also be stimulated including the dorsolateral prefrontal cortex, insula, anterior cingulate cortex, pre-supplementary, and supplementary motor area [all regions may be right or left hemisphere]. All of these regions have been shown to be involved in emotion regulation.

Conditions

Healthy

Study Design

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

Study Groups

Sham tDCS

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

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: DEVICE

Sham tDCS

Active tDCS

tDCS stimulation will be administered over the brain area of interest

Group Type: ACTIVE_COMPARATOR

tDCS

Intervention Type: DEVICE

tDCS

Interventions

tDCS

tDCS

Intervention Type: DEVICE

Sham tDCS

Sham tDCS

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Healthy males or females between 18 and 25 years old

2. 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.

3. Not currently in a romantic relationship

4. Ability to understand and follow instructions and oriented to name, time, and place.

5. No additional neurologic or psychiatric disorders

6. No current use of psychotropic drugs or during past 3 months (except marijuana and alcohol)

7. No current use of marijuana or during past 3 weeks

8. Not currently abusing alcohol

9. No history of alcohol or drug dependence within past 5 years

10. 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.

11. (Women): If stopped or started oral contraceptives recently, at least 60 days on/off oral contraceptives.

Exclusion Criteria

1. Left-handed or ambidextrous

2. Metallic dental implants

3. Metallic objects in the brain/skull

4. Medical device implants

5. Implanted electronic devices

6. History of seizures

7. History of strokes

8. Unexplained loss of consciousness

9. Frequent or severe headaches or neck pain

10. Clinically significant, uncontrolled liver, kidney, cardiac, or pulmonary disease

11. Terminal medical diagnosis consistent with survival < 1 year

12. Pregnancy; childbirth or miscarriage within 6 months, breastfeeding within 6 months of recruitment

13. Serious mental impairment. Mini mental state exam of < 23/30

14. Chronic skin disease

15. Previous experience with transcranial direct current stimulation (tDCS)

16. Regular tobacco use or tobacco use within past month

17. If using hormonal birth control, taking progestin-only pills (e.g., Cerazette, Ovrette), or Intrauterine devices (Mirena, Skyla), since progestin-only birth controls are more likely to cause mood swings.

1. Metal anywhere in the body

2. Weight over 250 pounds, or girth size incompatible for scanner bore.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

David Hsu

Assistant Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David T Hsu, PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook University

Stony Brook, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

SBU Psychiatry Pilot

Identifier Type: -

Identifier Source: org_study_id