Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women, ages 18 to 65
No current or history of neurological disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 hours
Awards & highlights
Study Summary
This trial is testing a new way to use transcranial magnetic stimulation (TMS) to treat mental illness. TMS is already approved by the FDA for depression and obsessive-compulsive disorder, but this new method may be more effective. The study will recruit patients with medication-resistant depression and test how well the new method works.
Who is the study for?
This trial is for right-handed adults aged 18-65 with depression who are not on antidepressants, have no seizure risk or neurological disorders, and understand English. It excludes those with MRI contraindications, history of seizures or ECT/rTMS failure, pregnancy/breastfeeding, substance abuse, psychotic/bipolar disorder, or certain medications.Check my eligibility
What is being tested?
The study tests personalized rTMS treatment against standard methods in medication-resistant depression. Participants undergo a double-blind trial comparing closed-loop rTMS (tailored to individual brain activity) to open-loop and sham (placebo) versions to see which best engages a biomarker linked to depression severity.See study design
What are the potential side effects?
rTMS may cause discomfort at the stimulation site, headache, lightheadedness, tingling sensations or muscle twitching during the procedure. Rarely it can induce seizures but this is minimized by excluding individuals with seizure risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I have no history of neurological disorders.
Select...
I am not taking any antidepressant medications.
Select...
I do not have seizures or a risk of developing them.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Transcranial Magnetic Stimulation (TMS) / Electroencephalography (EEG) change
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Closed-loop rTMSExperimental Treatment1 Intervention
Closed-loop rTMS will be delivered to determine the target engagement compared to open-loop rTMS. Closed loop rTMS will be applied for two consecutive days for 30 minutes to determine dose response. Closed- loop rTMS will be delivered using neuro-navigation based on participants' own MRI images. rTMS will last approximately 30 minutes (3000 pulses total) and will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the rTMS session for adverse events and/or side effects.
Group II: Open-loop rTMSActive Control1 Intervention
A series of open-loop rTMS protocols will be delivered to determine the most effective standard and individualized rTMS. Active rTMS will be delivered using neuro-navigation based on participants' own MRI images. For each clinically-utilized rTMS protocol (1Hz, 5Hz, 10Hz, 20Hz), 3000 pulses will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the rTMS session for adverse events and/or side effects.
Group III: Sham rTMSPlacebo Group1 Intervention
Sham rTMS will be delivered for two consecutive sessions to mimic active rTMS conditions. To maximize sham validity, both 1) a direction- sensor TMS coil will alert the operators to flip the coil if the wrong side is being used, and 2) low-intensity electrical stimulation to match the active rTMS frequency will be applied to scalp electrodes under the coil for sham and placed but not activated in the active arm. The rTMS coil will be positioned using neuro-navigation based on participants' own MRI images, mimicking active rTMS. Sham rTMS will last approximately 30 minutes (3000 pulses total) and will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the sham rTMS session for adverse events and/or side effects.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,566 Total Patients Enrolled
107 Trials studying Depression
93,884 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.I have no history of neurological disorders.You currently use drugs or alcohol in a way that is harmful or addictive.We will ask you some questions over the phone to check if you have depression.I have had a head injury that made me lose consciousness.I haven't taken any as-needed medication in the last 48 hours.I am not taking any antidepressant medications.I am taking medication that could make it easier for me to have seizures.I have been diagnosed with a psychotic or bipolar disorder.You have a medical condition that is not under control or keeps changing.I have tried ECT or rTMS treatments without success.I do not have any uncontrolled neurological or medical conditions.I have a history of seizures.I do not have seizures or a risk of developing them.
Research Study Groups:
This trial has the following groups:- Group 1: Closed-loop rTMS
- Group 2: Open-loop rTMS
- Group 3: Sham rTMS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do I meet the criteria to participate in this trial?
"This clinical trial is open to 54 melancholic people aged 18-65, with the following prerequisites: gender neutrality, current lack of antidepressant medication use, native English comprehension for EEG and TMS understanding as well as familiarity with clinical scales; right handedness; absence of neurological disorders or seizure risks; along with no PRN drug intake in a 48 hour period prior to scheduled appointment."
Answered by AI
Does this trial admit minors as participants?
"The minimum age requirement to be eligible for this trial is 18 years old, with a maximum age of 65."
Answered by AI
Are participants still being accepted for this investigation?
"Clinicaltrials.gov data shows that this clinical trial is currently recruiting for participants, with the original posting date of June 1st 2021 and an update on January 4th 2022."
Answered by AI
What is the participant quota for this research project?
"Affirmative. Records hosted on clinicaltrials.gov demonstrate that this research project, which was initially advertised on June 1st 2021 , is presently recruiting participants. Around 54 individuals need to be enlisted from one medical facility."
Answered by AI
Who else is applying?
What state do they live in?
Washington
How old are they?
18 - 65
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger