HealthyNCT02739789

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

A study testing tDCS in people with Healthy, run by Stony Brook University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: tDCS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 14 Feb 2018to 16 Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 25 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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)

Show all 11Show fewer

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.

Who cannot join

Left-handed or ambidextrous
Metallic dental implants
Metallic objects in the brain/skull
Medical device implants
Implanted electronic devices
History of seizures

Show all 20Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Stony Brook University
Stony Brook, New York, 11794-8101

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested: tDCS, Sham tDCS
Keywords: tDCS rejection affect mood fMRI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tDCSDevice
tDCS
Sham tDCSDevice
Sham tDCS

Study groups in NCT02739789
Study group	Role	What they receive
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 Receives: Device: Sham tDCS
Active tDCS	Active comparator	tDCS stimulation will be administered over the brain area of interest Receives: Device: tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 1-3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 201816 Oct 2018

First posted15 Apr 2016 (estimated)
Study start14 Feb 2018
Primary completion16 Oct 2018
Study completion16 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: within-subjects crossover design
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02739789
Sponsor's protocol ID: SBU Psychiatry Pilot
Status last verified: Jun 2020
First submitted: 1 Apr 2016
Last updated: 8 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Activating and Identifying Neural Responses to Social Rejection: a Combined Transcranial Direct Current Stimulation (tDCS) and Functional Magnetic Resonance Imaging (fMRI) Study
ClinicalTrials.gov ID: NCT02739789
Acronym / sponsor ID: SBU Psychiatry Pilot
Conditions: Healthy
Keywords: tDCS rejection affect mood fMRI
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Stony Brook UniversityUniversity, hospital or other
Study start: 14 Feb 2018 (actual)
Primary completion: 16 Oct 2018 (actual)
Study completion: 16 Oct 2018 (actual)
First posted: 15 Apr 2016 (estimated)
Results: Posted 8 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: within-subjects crossover design

Arm	Type	Receives
Sham tDCS	Sham comparator	Device: Sham tDCStDCS stimulation will be administered over the brain area of interest, but will be shorter in duration than the "active" treatment
Active tDCS	Active comparator	Device: tDCStDCS stimulation will be administered over the brain area of interest

Who may qualify

Ages: 18 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (20 listed)

Left-handed or ambidextrous
Metallic dental implants
Metallic objects in the brain/skull
Medical device implants
Implanted electronic devices

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tDCStDCS	Device	Active tDCS
Sham tDCSSham tDCS	Device	Sham tDCS

Primary outcome

Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units)
Time frame: 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).
Change in Positive and Negative Affect Scale (During fMRI)
Time frame: 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.
Change in the Single-item Self-Esteem Scale (During fMRI)
Time frame: 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).
Change in Desire for Social Interaction Scale (During fMRI)
Time frame: 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).

Results and safety

Results posted to the registry on 8 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham tDCS First, Then Active tDCS	9	9
Active tDCS First, Then Sham tDCS	10	10

Primary outcome: Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units)

Time frame: 1-3 weeks. Mean (Standard Deviation). Unit: Arbitrary units

Measure	Sham tDCS n = 16	Active tDCS n = 16
left VLPFC (Rejection-Neutral)	.57 (.77)	.66 (.80)
right VLPFC (Rejection-Neutral)	.25 (.49)	.29 (.38)
left VLPFC (Acceptance-Neutral)	.67 (.84)	.33 (.77)
right VLPFC (Acceptance-Neutral)	.40 (1.14)	.31 (.72)
left NAcc (R-N)	.01 (.25)	.18 (.42)
right NAcc (R-N)	.05 (.30)	.24 (.53)
left NAcc (A-N)	.09 (.38)	.27 (.38)
right NAcc (A-N)	.17 (.38)	.34 (.58)

Primary outcome: Change in Positive and Negative Affect Scale (During fMRI)

Time frame: 1-3 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Sham tDCS n = 16	Active tDCS n = 16
Rejection-Neutral conditions (sad and rejected)	14.06 (18.82)	12.81 (14.72)
Acceptance-Neutral conditions (sad and rejected)	6.00 (20.63)	-3.33 (13.84)
Rejection-Neutral conditions (happy and accepted)	-10.94 (22.89)	-5.31 (20.37)
Acceptance-Neutral conditions (happy and accepted)	0 (22.20)	12.00 (25.48)

Primary outcome: Change in the Single-item Self-Esteem Scale (During fMRI)

Time frame: 1-3 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Sham tDCS n = 16	Active tDCS n = 16
Rejection-Neutral conditions	-5.33 (18.46)	-2.67 (21.54)
Acceptance-Neutral conditions	0.71 (12.69)	8.57 (28.78)

Primary outcome: Change in Desire for Social Interaction Scale (During fMRI)

Time frame: 1-3 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Sham tDCS n = 16	Active tDCS n = 16
Rejection-Neutral conditions	-16.88 (35.72)	-13.75 (30.30)
Acceptance-Neutral conditions	-2.00 (14.24)	1.33 (19.22)

Adverse events

Time frame: Adverse event data were collected over the duration of time over which each participant was assessed. This was an average of 30 days (standard deviation = 16 days, range = 14 - 74 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham tDCS	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Active tDCS	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David T Hsu, PhD principal investigator

Stony Brook University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing tDCS in people with Healthy, run by Stony Brook University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) (time frame: 1-3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02739789.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.