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

20. juni 2020 oppdatert av: David Hsu, Stony Brook University

Activating and Identifying Neural Responses to Social Rejection: a Combined Transcranial Direct Current Stimulation (tDCS) and Functional Magnetic Resonance Imaging (fMRI) Study

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

19

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New York
      • Stony Brook, New York, Forente stater, 11794-8101
        • Stony Brook University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 25 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Addition Exclusion Criteria for participating in fMRI:

  1. Metal anywhere in the body
  2. Weight over 250 pounds, or girth size incompatible for scanner bore.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Sham-komparator: Sham tDCS
tDCS stimulation will be administered over the brain area of interest, but will be shorter in duration than the "active" treatment
Enhet: Sham tDCS
Sham tDCS
Aktiv komparator: Active tDCS
tDCS stimulation will be administered over the brain area of interest
Enhet: tDCS
tDCS

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units)
Tidsramme: 1-3 weeks
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)
Tidsramme: 1-3 weeks

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)
Tidsramme: 1-3 weeks

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)
Tidsramme: 1-3 weeks

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Stony Brook University

Etterforskere

  • Hovedetterforsker: David T Hsu, PhD, Stony Brook University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. februar 2018

Primær fullføring (Faktiske)

16. oktober 2018

Studiet fullført (Faktiske)

16. oktober 2018

Datoer for studieregistrering

Først innsendt

1. april 2016

Først innsendt som oppfylte QC-kriteriene

11. april 2016

Først lagt ut (Anslag)

15. april 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. juli 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juni 2020

Sist bekreftet

1. juni 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • SBU Psychiatry Pilot

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Nei

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