Theta Burst Stimulation in Young Adults With Depression
NCT03737032 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2024-03-19
Summary
For the proposed 2-year study, the investigators will conduct a within-subject, counterbalanced investigation using functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS) to examine the acute effects of theta-burst stimulation (TBS) on function in dorsomedial prefrontal cortex (dmPFC) in 35 young adults with depression (18-25 years, 50% female).
Conditions
Interventions
- DEVICE
-
Intermittent Theta Burst Stimulation
Theta Burst Stimulation, a form of Transcranial Magnetic Stimulation, will be applied to the dorsomedial prefrontal cortex. will include 600 pulses delivered in brief bursts of three pulses with a frequency of 50 Hz, at an intensity of 110% of resting motor threshold, and administered every 200 ms (5 Hz). Bursts will be delivered without interruption for a total duration of 40 seconds.
- DEVICE
-
Continuous Theta Burst Stimulation
Theta Burst Stimulation, a form of Transcranial Magnetic Stimulation, will be applied to the dorsomedial prefrontal cortex. will include 600 pulses delivered in brief bursts of three pulses with a frequency of 50 Hz, at an intensity of 110% of resting motor threshold, and administered every 200 ms (5 Hz). Bursts will be delivered during 2 second periods (10 bursts/period) interleaved with 8-second stimulation-free intervals, for a total duration of 190 seconds.
- DEVICE
-
Sham Theta Burst Stimulation
For the sham of theta burst stimulation, the device providing Theta Burst Stimulation can be placed in the same position and turned on, creating a similar experience for the participant, without providing any neural stimulation. Sham TBS will be delivered with a Cool-B65 Active/Placebo Coil, which includes a sham setting, and MagLink research software.
Sponsors & Collaborators
-
National Institute of Mental Health (NIMH)
collaborator NIH -
Erika Forbes
lead OTHER
Principal Investigators
-
Erika E Forbes, Ph.D. · The University of Pittsburgh
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-31
- Primary Completion
- 2022-07-31
- Completion
- 2022-07-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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