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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
History of seizures or on medications that substantially reduce seizure threshold
Neurological or uncontrolled medical disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 minutes
Awards & highlights
Summary
This trial aims to study how different types of brain stimulation affect brain activity in adult military Veterans. The goal is to use this information to create personalized brain stimulation techniques. Researchers will assess the changes in the
Who is the study for?
This trial is for English-speaking military veterans of any gender, aged 18 or older, who are experiencing major depressive disorder. Participants must not have a history of seizures, neurological diseases, active substance abuse, head trauma with loss of consciousness, and cannot be pregnant or breastfeeding. They also must be able to undergo MRI scans.
What is being tested?
The study is exploring how different types of transcranial magnetic stimulation (TMS), a non-invasive brain stimulation technique, affect brain activity in adults. The aim is to tailor personalized TMS treatments for depression based on these findings.
What are the potential side effects?
TMS may cause discomfort at the site of application on the scalp, headache or lightheadedness. In rare cases it can induce seizures but this risk is minimized by excluding individuals with seizure histories.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of seizures or take medication that lowers my seizure threshold.
Select...
I do not have any uncontrolled neurological or medical conditions.
Select...
I have had a head injury that made me lose consciousness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 45 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Transcranial Magnetic Stimulation (TMS) / Electroencephalography (EEG) change
Trial Design
2Treatment groups
Active Control
Group I: Standard TMSActive Control1 Intervention
A series of standard TMS protocols will be delivered to determine target engagement compared to seTMS. TMS will be delivered using neuro-navigation based on participant's own MRI images. Intensity will be set to 120% of the participant's motor threshold. Participants will be monitored during the session for adverse events and/or side effects.
Group II: Sensory-entrained TMS (seTMS)Active Control1 Intervention
Sensory entrained TMS (seTMS) is a combination of music and TMS to align brain oscillations and enhance the effects of TMS. seTMS will be delivered to determine target engagement to noninvasive seTMS brain stimulation compared to standard TMS. TMS will be delivered using neuro-navigation based on participant's own MRI images. Intensity will be set to 120% of the participant's motor threshold. Participants will be monitored during the session for adverse events and/or side effects.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,144 Total Patients Enrolled
109 Trials studying Depression
93,866 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,286 Total Patients Enrolled
688 Trials studying Depression
258,285 Patients Enrolled for Depression
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