Theta Burst Stimulation in Young Adults With Depression

Erika Forbes

Status: Completed

Conditions: Depression

Treatments: Device: Sham Theta Burst Stimulation; Device: Intermittent Theta Burst Stimulation; Device: Continuous Theta Burst Stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03737032

R21MH117400 (U.S. NIH Grant/Contract)

PRO18040159

Details and patient eligibility

About

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).

Full description

Each participant will undergo 3 sessions of TMS, one each of continuous and intermittent TBS--with the goal of decreasing or increasing dmPFC responding, respectively--and one of sham TBS. Session order will be counterbalanced, with a double-blind approach to condition. Brain function, behavior, and mood will be assessed before and after each TBS session. Broadly, the investigators predict that inhibitory TBS to the dmPFC will enhance neural, behavioral, and subjective aspects of reward function by reducing dmPFC function and dmPFC connectivity with the ventral striatum (VS).

Enrollment: 29 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• DSM-5 Diagnosis of Major Depressive Disorder, Persistent Depressive Disorder (Dysthymia), Other Specified Depressive Disorder, or Other Unspecified Depressive Disorder

Exclusion criteria

• Bipolar disorder, substance dependence, or lifetime history of psychosis
• Neurological disorder (e.g., seizure disorder)
• Pregnant
• MRI contradictions: claustrophobia, permanent orthodontic devices, metal implants or other forms of metal in the body that cannot be removed

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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29 participants in 6 patient groups

Intermittent, Continuous, Sham Order

Experimental group

Description:

3 sessions of theta burst stimulation administered in the following order: 1) Intermittent theta burst stimulation, 2) Continuous theta burst stimulation, 3) Sham theta burst stimulation.

Treatment:

Device: Sham Theta Burst Stimulation

Device: Continuous Theta Burst Stimulation

Device: Intermittent Theta Burst Stimulation

Intermittent, Sham, Continuous Order

Experimental group

Description:

3 sessions of theta burst stimulation administered in the following order: 1) Intermittent theta burst stimulation, 2) Sham theta burst stimulation, 3) Continuous theta burst stimulation.

Treatment:

Device: Sham Theta Burst Stimulation

Device: Continuous Theta Burst Stimulation

Device: Intermittent Theta Burst Stimulation

Continuous, Intermittent, Sham Order

Experimental group

Description:

3 sessions of theta burst stimulation administered in the following order: 1) Continuous theta burst stimulation, 2) Intermittent theta burst stimulation, 3) Sham theta burst stimulation.

Treatment:

Device: Sham Theta Burst Stimulation

Device: Continuous Theta Burst Stimulation

Device: Intermittent Theta Burst Stimulation

Continuous, Sham, Intermittent Order

Experimental group

Description:

3 sessions of theta burst stimulation administered in the following order: 1) Continuous theta burst stimulation, 2) Sham theta burst stimulation, 3) Intermittent theta burst stimulation.

Treatment:

Device: Sham Theta Burst Stimulation

Device: Continuous Theta Burst Stimulation

Device: Intermittent Theta Burst Stimulation

Sham, Intermittent, Continuous Order

Experimental group

Description:

3 sessions of theta burst stimulation administered in the following order: 1) Sham theta burst stimulation, 2) Intermittent theta burst stimulation, 3) Continuous theta burst stimulation.

Treatment:

Device: Sham Theta Burst Stimulation

Device: Continuous Theta Burst Stimulation

Device: Intermittent Theta Burst Stimulation

Sham, Continuous, Intermittent Order

Experimental group

Description:

3 sessions of theta burst stimulation administered in the following order: 1) Sham theta burst stimulation, 2) Continuous theta burst stimulation, 3) Intermittent theta burst stimulation.

Treatment:

Device: Sham Theta Burst Stimulation

Device: Continuous Theta Burst Stimulation

Device: Intermittent Theta Burst Stimulation