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Behavioural Intervention
TMS for Depression
N/A
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 18-65 years old
Diagnosis of major depressive or persistent depressive disorder as per SCID clinical interview
Must not have
History of neurological disorder or traumatic brain injury (other than mild)
Unable to have an MRI scan, or current or prior medical condition that could interfere with the collection or interpretation of MRI data
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study how the brain responds to transcranial magnetic stimulation (TMS) in people with depression by focusing on a specific brain region called the subgenual anterior cingulate cortex
Who is the study for?
This trial is for individuals with various forms of depression, including persistent depressive disorder and major depressive disorder. Participants must be eligible to undergo MRI scans and receive daily TMS treatments on weekdays for 4-6 weeks.
What is being tested?
The study is testing how a brain region called the subgenual anterior cingulate cortex (sgACC) responds to Transcranial Magnetic Stimulation (TMS). It involves daily TMS sessions combined with MRI scans to observe changes in sgACC engagement during treatment.
What are the potential side effects?
TMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases. The MRI procedure might lead to discomfort due to its enclosed nature and loud noises during scanning.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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I have been diagnosed with major or persistent depression.
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I can understand and agree to the study's requirements.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of a serious neurological disorder or traumatic brain injury.
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I cannot have an MRI or have a condition that affects MRI results.
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I am not currently experiencing severe lack of sleep or effects from drugs.
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I did not improve after undergoing rTMS or ECT/MST treatments.
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I am currently taking medication for mental health issues.
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I am taking more than 350 mg of Wellbutrin.
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I cannot undergo or tolerate TMS therapy.
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I have a history of stroke, epilepsy, or brain scarring.
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I am not taking stimulants or drugs like cyclosporine that can affect the brain.
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I am on dialysis.
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I have difficulty getting to daily treatment sessions due to transportation or physical issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
sgACC Blood Oxygen Level Dependent (BOLD) signal change following single-pulse fMRI-guided TMS (TMS On vs TMS Off)
Secondary study objectives
Change in sgACC evoked response Pre/Post TMS treatment with positive and negative sgACC correlated targets
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Anticorrelation TargetActive Control1 Intervention
TMS treatment will be administered using a TMS target anticorrelated with the sgACC.
Group II: Positive Correlation TargetActive Control1 Intervention
TMS treatment will be administered using a TMS target positively correlated with the sgACC.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,075 Previous Clinical Trials
42,719,796 Total Patients Enrolled
70 Trials studying Depression
29,945 Patients Enrolled for Depression
National Institutes of Health (NIH)NIH
2,811 Previous Clinical Trials
8,161,208 Total Patients Enrolled
59 Trials studying Depression
48,144 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,913 Previous Clinical Trials
2,738,485 Total Patients Enrolled
699 Trials studying Depression
260,881 Patients Enrolled for Depression
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