Exploring brain stimulation effects on decision-making in depression
Brain Stimulation Studies of Decision-making Using Repetitive Transcranial Magnetic Stimulation (rTMS) and Temporal Interference (TI)
NA · Emory University · NCT04099056
This study is testing if brain stimulation can help people with depression make better decisions during challenging tasks compared to healthy individuals.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Emory University (other) |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT04099056 on ClinicalTrials.gov |
What this trial studies
This project investigates how brain regions involved in decision-making are affected by depression, particularly during challenging choices. Participants with depression and healthy controls will engage in game-like tasks while receiving transcranial magnetic stimulation (TMS) or temporal interference (TI) to assess the impact of these interventions on cognitive control and choice behavior. The study aims to clarify the relationship between brain stimulation and decision-making processes, leveraging advanced neuromodulation techniques alongside behavioral assessments.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with depression who are fluent in English and meet specific health criteria.
Not a fit: Patients who are pregnant, have contraindications to fMRI or TMS, or are currently using drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of decision-making impairments in depression and lead to improved therapeutic strategies.
How similar studies have performed: Previous studies using TMS and TI have shown promise in understanding cognitive processes, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provides written informed consent * Fluent English speaker * Absence of current drug use as assessed by subject history and/or urine drug screen Exclusion Criteria: * Pregnant or currently breastfeeding women or any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant, as assessed by subject report and/or urine pregnancy screen * Contraindications to fMRI scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia) as assessed with the standard MRI screening form from the Facility for Research and Education in Neuroscience (FERN) * Unable to fit comfortably in the scanner * Contraindication to TMS, including history or family history of epilepsy, metallic implants in the head and/or neck, brain stimulators, vagus nerve stimulators, ventriculoperitoneal (VP) shunt, pacemakers * Current use of medications that may increase the risk of seizures (e.g., bupropion, varenicline, chlorpromazine, theophylline) or reduce the effects of rTMS, such as benzodiazepines * History or current serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease, as assessed by subject history * Not right-handed as assessed by the Chapman handedness inventory or self-report * History of head injury resulting in more than a brief loss of consciousness, as assessed by subject history * History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine), as assessed by subject history * History of use of dopaminergic drugs (including methylphenidate or other stimulant medication), as assessed by subject history * Current use or more than occasional use in the past year of tobacco products, including cigarettes, e-cigarettes, cigars, snuff, and chewing tobacco, or nicotine replacement products such as gum or patches, as assessed by subject history * Evidence of significant inconsistencies in self-report measures Additional Exclusion Criteria for Optional Ecological Momentary Assessment (EMA)Component for Subject Safety * Anything above minimal risk for suicide, as assessed during the clinical interview (SCID) at screening and the Columbia Suicide Severity Rating Scale (C-SSR). C-SSRS risk will be assessed as any score \> 3. * Any physical or neuropsychiatric conditions that may worsen/or prevent walking or running. Additional Exclusion Criteria for Optional Ecological Momentary Assessment (EMA)Component for Data Quality * Meet criteria for current psychotic disorders, bipolar disorders, or severe substance use disorders as assessed by the Mini International Neuropsychiatric Interview. * Used psychotropic medications within the last six weeks as assessed by subject history. Additional Exclusion Criteria for Participants with Major Depressive Disorder: * Anything above minimal risk for suicide, as assessed during the clinical interview (SCID) at screening and the Columbia Suicide Severity Rating Scale (C-SSRS) * A symptom severity score of at least 11, as assessed by the Beck Depression Inventory (BDI)-II * History or current diagnosis of any of the following Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV psychiatric illnesses: * Organic mental disorder * Schizophrenia spectrum disorders * Delusional disorder * Psychotic disorders not otherwise specified * Patients with mood-congruent or mood-incongruent psychotic features * Patients with bipolar mood disorders * Substance dependence * Substance abuse within the last 12 months (except cocaine or stimulant abuse), which will lead to exclusion * Absence of any psychotropic medications for at least 2 weeks. No patient will be asked to discontinue or otherwise interrupt any psychotropic medications to participate in this study. The listed "washout" periods are only applicable for patients who previously used psychotropic medications, but recently decided to discontinue their use for some other reason. * 6 weeks for fluoxetine * 6 months for neuroleptics * 2 weeks for benzodiazepines * 2 weeks for any other antidepressants Additional Exclusion Criteria for Healthy Controls: * Any current or past history of any DSM-IV psychiatric illnesses, presence of a DSM-IV psychiatric disorder within a first-degree relative, or current or past use of psychotropic medications * Score no greater than 10 on the BDI-II * Score \> 1 on the SHAPS
Where this trial is running
Atlanta, Georgia
- Emory University — Atlanta, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Michael Treadway, PhD — Emory University
- Study coordinator: Michael Treadway, PhD
- Email: tread.lab.cbid@emory.edu
- Phone: 404 727-3166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depression, Transcranial magnetic stimulation, Temporal Interference