N/A
N=19
Activating and Identifying Neural Responses to Social Rejection: a Combined tDCS and fMRI Study
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02739789 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) — .57; .66; .25; .29 Arbitrary units
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- tDCS (Device); Sham tDCS (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stony Brook University
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) |
.57; .66; .25; .29; .67; .33 | — |
| PRIMARY Change in Positive and Negative Affect Scale (During fMRI) |
14.06; 12.81; 6.00; -3.33; -10.94; -5.31 | — |
| PRIMARY Change in the Single-item Self-Esteem Scale (During fMRI) |
-5.33; -2.67; 0.71; 8.57 | — |
| PRIMARY Change in Desire for Social Interaction Scale (During fMRI) |
-16.88; -13.75; -2.00; 1.33 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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)
- Regular tobacco use or tobacco use within past month
- 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.
Addition Exclusion Criteria for participating in fMRI:
- Metal anywhere in the body
- Weight over 250 pounds, or girth size incompatible for scanner bore.
Data sourced from ClinicalTrials.gov (NCT02739789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.