RecruitingNot ApplicableNCT03417960

Accelerated iTBS for Post Partum Depression

An Open Label Study to Assess the Feasibility and Tolerability of Accelerated Theta Burst Repetitive Transcranial Magnetic Stimulation (iTBS-rTMS) for the Treatment of Post-Partum Depression

Sponsor

Medical University of South Carolina

Enrollment

40 participants

Start Date

Jan 24, 2018

Study Type

INTERVENTIONAL

Conditions

Post Partum Depression

Summary

Study 1: The investigators are studying the feasibility and tolerability of 10x/day intermittent theta burst (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over the course of 6 days for women with post-partum depression. The investigators further aim to characterize the anticipated anti-depressant effect of this treatment paradigm. Study 2: The investigators are studying the feasibility and tolerability of 12 sessions/day of intermittent theta burse (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over 5 days for women with post-partum depression. The investigators aim to compare the two different treatment schedules.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a type of non-invasive brain stimulation called accelerated TMS (transcranial magnetic stimulation) as a treatment for postpartum depression — depression that starts within the first year after having a baby. **You may be eligible if...** - You are 18 years or older - You developed depression within the first year after giving birth - Your depression score on a standard rating scale is 14 or higher at the start of the study - You are able to provide consent and complete the assessments **You may NOT be eligible if...** - You are currently pregnant - You have a moderate to severe substance use disorder (except tobacco) - You have a pacemaker, metal implants in your head, or a history of seizures (due to the brain stimulation device) - You have a diagnosis of schizophrenia or other psychotic disorders - You are at high risk of suicide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEiTBS

The investigators will treat post-partum depressed subjects with accelerated intermittent theta burst stimulation. iTBS will be delivered via a MagVenture MagPro100 and Cool-B65 coil. The investigators will use a standard resting motor threshold (rMT) determination to determine the TMS dose. Treatment will be delivered at 120% of the motor threshold. In study 1, the accelerated paradigm will consist of 10 such sessions separated by 15 minutes, for three treatment days per week. There will be 2 weeks of 10 sessions on each of three days for a total of six treatment days, divided by one treatment-free week between treatment weeks. In study 2, the accelerated paradigm will consist of 12 sessions per day for 5 total treatment days. Treatments will be delivered at the 10-20 EEG coordinate for F3 (approximating the left DLPFC), and will be found using the Beam-F3 method.