Brain Connectivity in Depression

Status:	Recruiting
Conditions:	Depression, Depression
Therapuetic Areas:	Psychiatry / Psychology
Healthy:	No
Age Range:	18 - 70
Updated:	12/12/2018
Start Date:	April 3, 2018
End Date:	October 31, 2022
Contact:	Danielle Cooke, BS
Email:	dcooke1@bidmc.harvard.edu
Phone:	617-667-0362

Using Human Brain Connectivity to Identify the Causal Neuroanatomical Substrate of Depression Symptoms

This study will include 60 subjects with medication-refractory depression undergoing
transcranial magnetic stimulation (TMS) to the left dorsal lateral prefrontal cortex (DLPFC).
In order to obtain good quality data and account for attrition, 80 subjects will be
recruited. Subjects will be recruited from the Clinical Program of FDA approved TMS at the
Berenson-Allen Center and the Butler TMS Clinic (40 per site). Subjects will undergo an
hour-long MRI scanning session, an optional DNA-sample collection, up to three 20 minute
neuronavigation sessions for marking the site of TMS stimulation, questionnaires, and a
behavioral testing battery before and after their TMS treatment course. The task battery will
last 45-60 minutes and consist of the Emotion Conflict Resolution (ECR) task, Multi-Source
Interference Task (MSIT), War Game (Gambling) task, and Associative Learning with Reversal
task. Subjects' scores on the Hamilton Depression Rating Scale (HDRS) and Beck Depression
Inventory (BDI) will also be assessed before and after the TMS course. MRI data will be
utilized to identify brain regions whose connectivity to the stimulation site co-varies with
the aforementioned objective measures of symptom improvement.

Inclusion Criteria:

1. Male or female

2. Aged 18-70.

3. Have previously received or will receive TMS to the left dorsal-lateral prefrontal
cortex as part of the clinical treatment program at the Berenson-Allen Center for
Non-invasive Brain Stimulation or the Psychiatric Neurotherapeutics program at McLean
Hospital for treatment of medication resistant depression

Exclusion Criteria:

1. Any current or past history of a major psychiatric illness other than depression (e.g.
bipolar affective disorder, schizophrenia, obsessive compulsive disorder,
post-traumatic stress disorder, generalized anxiety disorder)

2. Any significant current neurological illness (e.g. a history of seizures or
unexplained loss of consciousness, a family history of epilepsy, signs of increased
intracranial pressure, previously abnormal MRI scans, parkinsonism or dementia). Of
note, most of these are also contraindications to receiving TMS and these patients
would not be enrolled in the clinical treatment program.

3. Patients who are pregnant or lactating (by menstrual history)

4. Current abuse of an illicit substance (e.g. marijuana, cocaine, heroin, hallucinogens,
psychostimulants)

5. Positive MRI screen that would preclude the subject from undergoing magnetic resonance
imaging. These include, but are not limited to any of the following:

1. Known metal in the head (such as a surgical aneurysm clip), or a history of prior
neurosurgical procedures

2. Ferromagnetic bioimplants activated by any electronic, mechanical or magnetic
means such as: cochlear implants, pacemakers, medication pumps, vagal
stimulators, deep brain stimulators, neurostimulators, biostimulators, or
ventriculo-peritoneal shunts

3. Subjects who have or might have bullet fragments or other metal fragments
(veterans or workers exposed to metal in their work environment)

4. Subjects with metallic paint (e.g. color contact lenses, tattoos, metallic
eyeliner)

5. Subjects expressing significant anxiety or claustrophobia about being in the
magnet.

6. Subjects that cannot adhere to the experimental protocol for any reason.

We found this trial at

sites

Beth Israel Deaconess Medical Center

330 Brookline Ave
Boston, Massachusetts 02215

617-667-7000