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Can electrical stimulation reduce brain activity in brain regions involved in reward responses linked to risk-taking behavior in people with bipolar disorder?

Modulation of ventrolateral prefrontal cortical activity during reward processing by transcranial direct current stimulation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11314056
Enrollment
134
Registered
2019-02-13
Start date
2016-09-01
Completion date
Unknown
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar disorder Mental and Behavioural Disorders

Interventions

After determining eligibility at a visit 1 via clinical screening, the participants were scheduled for 2 scan visits (Visits 2 and 3). Scan visits comprised the same procedures except that participant

Sponsors

University of Pittsburgh
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All participants: 1. Right-handed (Annett criteria) 2. Aged 18-45 years 3. Able to give basic informed consent 4. Women of childbearing potential must agree to a urine pregnancy test Adults with no psychiatric history (healthy controls): 5. No previous/present psychiatric history of any disorder including Substance Use Disorders (SCID-5 criteria) 6. No family history of psychiatric illness (Family History Questionnaire criteria) Adults with Bipolar Disorder I (BDI): 7. In remission with a diagnosis of BDI (DSM-5 criteria; euthymic for more than 2 months) 8. Any antidepressant, any mood stabilizer, any atypical antipsychotic, or any combination of atypical antipsychotics and/or mood stabilizers and/or antidepressants taken for 2 months or longer or unmedicated individuals

Exclusion criteria

Exclusion criteria: All participants: 1. Not native English speaking or not fluent 2. History of head injury/severe concussion, neurological, pervasive developmental disorder (e.g. autism), or systemic medical disease (that could impact fMRI scans; from medical records and report by each potential participant) 3. Mini-Mental State Examination (cognitive state) score 7 on the Hamilton Rating Scale for Depression (HRDS) 13. Score >10 on the Young Mania Rating Scale (YMRS) 14. Psychotic: Score of 3 or more on suspiciousness, hallucinations, unusual thought content subscales of the Brief Psychiatric Rating Scale (BPRS) Adults with no psychiatric history (healthy controls): 15. Lifetime history of alcohol/substance abuse/dependence (including nicotine) and/or illicit substance use (except cannabis), determined by Structured Clinical Interview for DSM-5 (SCID-5)(50). Urine tests on the scan day will exclude individuals with current illicit substance use (except cannabis); salivary alcohol tests will exclude individuals who are intoxicated on the scan day. Alcohol/nicotine/caffeine/cannabis use (below SCID-5 abuse/dependence levels) per week will be allowed, recorded for all individuals 16. Lifetime history of psychotropic medicine use 17. First degree relative with Axis I disorder 18. Present/previous personal history of psychiatric illness in childhood or after the age of 18 years (SCID-I)

Design outcomes

Primary

MeasureTime frame
1. Reward expectancy (RE) activation assessed using blood-oxygen-level dependent (BOLD) signal change in MRI scan at the scan visit of left vlPFC, VS and amygdala, using as regions of interest the left vlPFC mask created from previous studies of reward processing in BD, a VS mask based on prior reward-related activation loci with the same paradigm, and an amygdala mask, using the SPM atlas toolbox (http://fmri.wfubmc.edu/) 2. RE functional connectivity measured by extracted parameter estimates in the brain by MRI at the scan visit

Secondary

MeasureTime frame
1. Prediction error (PE)-related VS activation measured by BOLD signal change in the brain by MRI at the scan visit Added 27/02/2019: 2. Risky decision making is measured by performance on a risky decision making task, which occurs after each scan 3. Affect is measured by the Hamilton Rating Scale for Depression (HRSD) and Young Mania Rating Scale (YMRS) at the screen visit as well as before and after each scan

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026