What this study is
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.
What's being tested
- iTBS
Intervention · DEVICE
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.
Study details
- Official title
- 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
- Conditions
- Post Partum Depression
- Enrolling
- 40 people
- Starts
- 2018-01-24
- Est. completion
- 2027-08-30
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 50 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Participants must be over the age of 18.
- Participants must meet criteria for post-partum depression: a) onset of symptoms in the first year postpartum
- Participants must have a HRSD17 greater than or equal to 14 at baseline.
You can't join if
- Participants must not be pregnant.
- Participants must not meet moderate or severe use disorder of any substance with the exception of Tobacco Use Disorder.
- Participants must not have current psychotic symptoms.
- Participants must not have a history of dementia or other cognitive impairment.
- Participants must not have active suicidal ideation requiring hospitalization or a suicide attempt within the past 3 months.
- Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the neck, history of seizure, any known brain lesion).
- Participants must not have any unstable general medical conditions.
- Participants must not have had eclampsia during pregnancy.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMedical University of South Carolina
Charleston, South Carolina, United States
- Lisa McTeague, PhD · Contact843-792-8274mcteague@musc.edu
Recruiting
Study team
Sponsor
Medical University of South Carolina
Study ID Pro00073886
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.