NCT05194098 · San Francisco Veterans Affairs Medical Center
Using Electrophysiology to Index Non-invasive Brain Stimulation Effects on Reward System Functioning in Depression
What this study is about
Depression is a leading cause of morbidity and mortality, conferring substantial healthcare and societal costs.
View original scientific description
Depression is a leading cause of morbidity and mortality, conferring substantial healthcare and societal costs. By studying methods to non-invasively target neural circuitry involved in reward responsivity, information generated by this project will improve understanding of the circuit alterations that underlie motivation and pleasure deficits in depression, and could also lead to the development of biologically-based markers of neurostimulation-based treatment response.
Interventions
DEVICE
TMS: single session intermittent theta burst stimulation (iTBS) to dorsomedial prefrontal target in individuals with major depressive disorder, via MagVenture MagPro R30 device / Cool-DB80 A/P coil
Active Session: Single session of standard iTBS of 50Hz triplet bursts, 5 times each second with a 2 s on / 8 s off duty cycle for 600 pulses per hemisphere (1200 pulses total) will be applied for a total stimulation time of 6:40 minutes
DEVICE
SHAM (inactive) TMS stimulation
Sham neurostimulation (SHAM) entails use of the sham side of the D-B80 A/P placed over the same anatomical target, without any active stimulation.
Primary outcome measures
Targeted neurostimulation effects on reward feedback evaluation
Time frame: EEG measurements are collected directly after neurostimulation (iTBS vs SHAM) sessions
Within the MDD group, the investigators will examine whether neurostimulation of a dmPFC target induces changes in the Reward Positivity (RewP) event-related potential component by comparing RewP amplitude after iTBS to RewP amplitude after sham stimulation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- All participants
- 18-65 years old
- Normal (or corrected to normal) vision
- Participants with MDD
- Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for MDD
- Screened for TMS and MRI safety
- On a stable psychiatric medication regime for \> 1 month
Exclusion criteria
- (all participants):
- Premorbid IQ estimate \< 70
- Past or present neurological problems (including seizures and head trauma resulting in neurological or cognitive sequelae)
- Loss of consciousness \> 30 minutes or any loss of consciousness with neurological sequelae
- Major medical conditions (e.g., seizure disorders, treatment with anticonvulsant medication, endocrine disorders, significant cardiac pathology), or other physical conditions if they preclude participation in EEG, TMS, or MRI protocols (e.g. peripheral nerve damage, limb paralysis etc.)
- Substance dependence, within the past year, current (past 3 months) substance misuse, or failed urine toxicology on the day of neuroimaging sessions
- Known claustrophobia
- Pregnancy (a pregnancy urine test will be conducted to rule-out pregnancy) Exclusion criteria (Participants with MDD only)
- Past or present DSM-5 (SCID-5) 'Schizophrenia Spectrum or Other Psychotic Disorder' diagnosis
- Past or present DSM-5 (SCID-5) Bipolar and Related Disorders Diagnosis
- Past or present DSM-5 (SCID-5) MDD with psychotic features (mood congruent or mood incongruent)
- Past or present DSM-5 (SCID-5) Gambling Disorder Exclusion Criteria (HCs only) • DSM-5 (SCID-5) criteria for any psychiatric disorder
Where
- San Francisco, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 2, 2024 · Source of record for eligibility and locations