Healthy AdultsNCT03374631
Stimulating the Social Brain
A study testing active anodal tDCS in people with Healthy Adults, run by The University of Texas at Dallas at 1 site in United States.
Trial summary
This study investigates whether the way in which individuals process social stimuli can be altered, and specifically, whether feelings of paranoia and suspiciousness can be reduced by stimulating the brain's regulatory regions via transcranial Direct Current Stimulation (tDCS). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- active anodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 1 Oct 2020
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- between the ages of 18 ad 35
- previous classification as being high in sub-clinical paranoia
Who cannot join
- diagnosis of mental illness
- use of psychotropic medication
- Presence or history of medical, cardiac, or neurological disorders that may affect brain function (e.g., cardiac disease, endocrine disorders, renal disease, pulmonary disease, history of seizures or head trauma with unconsciousness for a period of 15 minutes or greater or CNS tumors)
- Presence of sensory limitation including visual (e.g., blindness, glaucoma, vision uncorrectable to 20/40) or hearing (e.g. hearing loss) impairments that interfere with assessment
- Not proficient in English
- Contraindications for tDCS (e.g., pregnancy or implanted devices such as pace maker)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Unversity of Texas at Dallas
Richardson, Texas, 75080
About this study
This study investigates whether the way in which individuals process social stimuli can be altered, and specifically, whether feelings of paranoia and suspiciousness can be reduced by stimulating the brain's regulatory regions via transcranial Direct Current Stimulation (tDCS).
Read the detailed description
Although paranoid ideation is typically associated with severe mental illnesses such as schizophrenia or bipolar disorder, 10-15% of individuals in the general population report experiencing paranoid thoughts on a regular basis. These individuals who are high in sub-clinical paranoia can show impaired work and social functioning as compared to individuals low in sub-clinical paranoia. The wide spread prevalence and negative functional impact of heightened paranoia reinforces the need to develop interventions that may help to reduce problematic patterns of paranoid thinking in both healthy individuals and those with mental illness.
Transcranial Direct Current Stimulation (tDCS) is a form of noninvasive neurostimulation which has been proposed as a therapeutic procedure in numerous psychiatric conditions. TDCS therefore may be a promising therapeutic technique for reducing symptoms of psychosis, and specifically paranoia. This study will compare experiences of paranoid ideation in individuals who are high in sub-clinical paranoia across two conditions: active anodal tDCS and sham tDCS.
- Conditions
- Healthy Adults
- Being tested
- active anodal tDCS, sham tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active anodal tDCSDevice
active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation
sham tDCSDevice
sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation
| Study group | Role | What they receive |
|---|---|---|
| Active anodal tDCS, Then Sham tDCS | Experimental | Active anodal tDCS followed by behavioral testing; one week later, sham tDCS followed by behavioral testing Receives: Device: active anodal tDCS; Device: sham tDCS |
| Sham tDCS, then Active anodal tDCS | Sham comparator | Sham tDCS followed by behavioral testing; one week later, active anodal tDCS followed by behavioral testing. Receives: Device: active anodal tDCS; Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in General Paranoid Ideation for Active vs. Sham Simulation
Level of paranoid ideation will be assessed with the self-report Paranoia Scale (PS; Fenigstein \& Vanable, 1992) both before and after tDCS to assess changes related to tDCS. The PS is a self-report measure designed to assess sub-clinical paranoid thought. Scores range from 20-100 with higher scores indicating higher levels of paranoia. The amount of pre-post change (i.e. PS score assessed before stimulation minus score after stimulation) is the primary value of interest and will be compared between active and sham stimulation. Improvements in paranoia will be indicated by positive values.
Measured: Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation
Change in Change in Social Paranoia for Active vs. Sham Simulation
Level of paranoid ideation will be assessed with the persecution subscale of the State Social Paranoia Scale (SSPS: Freeman et al., 2007) both before and after tDCS to assess changes related to tDCS. The SSPS is a psychometrically sound 20-item self- report measure assessing current levels of paranoid, positive, and neutral thinking about others. Ten items comprise the persecution subscale, and scores on this subscale range from 10-50 with higher scores indicating greater paranoia. The amount of pre-post change (i.e.SSPS score before stimulation minus SSPS score after stimulation) will be compared between active and sham stimulation. Positive values indicate reductions in paranoia after stimulation.
Measured: Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation
Secondary outcomes (2)
Trustworthiness Task Score for Active vs. Sham Stimulation
Participants will complete the Trustworthiness Task (Adolphs, Tranel, \& Damasio, 1998), which asks individuals to view 42 images of others and rate their level of trustworthiness on a scale from -3 to 3. Scores range from -126 to 126. Higher scores indicate greater perceptions of trustworthiness. Mean ratings following each stimulation type (active vs. sham) are calculated.
Measured: assessed 30 minutes after completion of the active/sham stimulation
Penn Emotion Recognition Test for Active vs. Sham Stimulation
The Emotion Recognition 40 (ER-40; Kohler, Turner, Bilker, Brinsinger, Siegel, Kanes... Gur, 2003) is a standardized, computer administered measure of facial affect recognition ability. It includes 40 color photographs of faces expressing 4 basic emotions (i.e. happiness, sadness, anger or fear) and neutral expressions. Participants view one face at a time and are asked to choose the correct emotion for each face. Scores range from 0-40 with higher scores indicating better accuracy. Mean performance following each stimulation type (active vs. sham) are calculated.
Measured: assessed 30 minutes after completion of the active/sham stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start1 Dec 2017
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
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 Healthy AdultsStudies 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
- Participants will complete active and sham simulation sessions in a randomized, counterbalanced order approximately one week apart.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Pinkham, PhD, The University of Texas at Dallas
- Investigators
- Amy Pinkham, PhD, Principal investigator, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374631
- Sponsor's protocol ID
- 17-126
- Status last verified
- Mar 2023
- First submitted
- 7 Dec 2017
- Last updated
- 22 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulating the Social Brain
- ClinicalTrials.gov ID
- NCT03374631
- Acronym / sponsor ID
- 17-126
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Posted 1 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether the way in which individuals process social stimuli can be altered, and specifically, whether feelings of paranoia and suspiciousness can be reduced by stimulating the brain's regulatory regions via transcranial Direct Current Stimulation (tDCS).
Detailed description
Although paranoid ideation is typically associated with severe mental illnesses such as schizophrenia or bipolar disorder, 10-15% of individuals in the general population report experiencing paranoid thoughts on a regular basis. These individuals who are high in sub-clinical paranoia can show impaired work and social functioning as compared to individuals low in sub-clinical paranoia. The wide spread prevalence and negative functional impact of heightened paranoia reinforces the need to develop interventions that may help to reduce problematic patterns of paranoid thinking in both healthy individuals and those with mental illness.
Transcranial Direct Current Stimulation (tDCS) is a form of noninvasive neurostimulation which has been proposed as a therapeutic procedure in numerous psychiatric conditions. TDCS therefore may be a promising therapeutic technique for reducing symptoms of psychosis, and specifically paranoia. This study will compare experiences of paranoid ideation in individuals who are high in sub-clinical paranoia across two conditions: active anodal tDCS and sham tDCS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will complete active and sham simulation sessions in a randomized, counterbalanced order approximately one week apart.
| Arm | Type | Receives |
|---|---|---|
| Active anodal tDCS, Then Sham tDCS | Experimental | Device: active anodal tDCS, Device: sham tDCSActive anodal tDCS followed by behavioral testing; one week later, sham tDCS followed by behavioral testing |
| Sham tDCS, then Active anodal tDCS | Sham comparator | Device: active anodal tDCS, Device: sham tDCSSham tDCS followed by behavioral testing; one week later, active anodal tDCS followed by behavioral testing. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- between the ages of 18 ad 35
- previous classification as being high in sub-clinical paranoia
Key exclusion criteria (6 listed)
- diagnosis of mental illness
- use of psychotropic medication
- Presence or history of medical, cardiac, or neurological disorders that may affect brain function (e.g., cardiac disease, endocrine disorders, renal disease, pulmonary disease, history of seizures or head trauma with unconsciousness for a period of 15 minutes or greater or CNS tumors)
- Presence of sensory limitation including visual (e.g., blindness, glaucoma, vision uncorrectable to 20/40) or hearing (e.g. hearing loss) impairments that interfere with assessment
- Not proficient in English
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 |
|---|---|---|
| active anodal tDCSactive anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation | Device | Active anodal tDCS, Then Sham tDCS, Sham tDCS, then Active anodal tDCS |
| sham tDCSsham tDCS with behavioral tasks and self-report measures to assess paranoid ideation | Device | Active anodal tDCS, Then Sham tDCS, Sham tDCS, then Active anodal tDCS |
Primary outcome
Change in General Paranoid Ideation for Active vs. Sham Simulation
Time frame: Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation
Level of paranoid ideation will be assessed with the self-report Paranoia Scale (PS; Fenigstein \& Vanable, 1992) both before and after tDCS to assess changes related to tDCS. The PS is a self-report measure designed to assess sub-clinical paranoid thought. Scores range from 20-100 with higher scores indicating higher levels of paranoia. The amount of pre-post change (i.e. PS score assessed before stimulation minus score after stimulation) is the primary value of interest and will be compared between active and sham stimulation. Improvements in paranoia will be indicated by positive values.
Change in Change in Social Paranoia for Active vs. Sham Simulation
Time frame: Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation
Level of paranoid ideation will be assessed with the persecution subscale of the State Social Paranoia Scale (SSPS: Freeman et al., 2007) both before and after tDCS to assess changes related to tDCS. The SSPS is a psychometrically sound 20-item self- report measure assessing current levels of paranoid, positive, and neutral thinking about others. Ten items comprise the persecution subscale, and scores on this subscale range from 10-50 with higher scores indicating greater paranoia. The amount of pre-post change (i.e.SSPS score before stimulation minus SSPS score after stimulation) will be compared between active and sham stimulation. Positive values indicate reductions in paranoia after stimulation.
2 secondary outcomes
Trustworthiness Task Score for Active vs. Sham Stimulation
Time frame: assessed 30 minutes after completion of the active/sham stimulation
Penn Emotion Recognition Test for Active vs. Sham Stimulation
Time frame: assessed 30 minutes after completion of the active/sham stimulation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Healthy Participants
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.
Amy Pinkham, PhD principal investigator
The University of Texas at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active anodal tDCS in people with Healthy Adults, run by The University of Texas at Dallas 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 2 inclusion and 6 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 22 Mar 2023. 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 1 Aug 2022). 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?
Change in General Paranoid Ideation for Active vs. Sham Simulation (time frame: Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2023.