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.
Full Title of Study: “Using Human Brain Connectivity to Identify the Causal Neuroanatomical Substrate of Depression Symptoms”
- Study Type: Interventional
- Study Design
- Intervention Model: Single Group Assignment
- Primary Purpose: Basic Science
- Masking: None (Open Label)
- Study Primary Completion Date: October 31, 2022
- Other: MRI scan and behavioral testing
- Patients will undergo an MRI scan and behavioral testing
Arms, Groups and Cohorts
- Experimental: MRI and behavioral assessment
- Subjects will undergo an hour-long MRI scanning session, a marking for the site of planned clinical TMS stimulation and a behavioral testing battery before and after their TMS treatment course.
Clinical Trial Outcome Measures
- Prediction of rTMS clinical response
- Time Frame: 1 year after study completion
- Connectivity between each patient’s stimulation site and the subgenual cingulate will be used to predict clinical response to rTMS
Participating in This Clinical Trial
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
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
Link Original: https://trialbulletin.com/lib/entry/ct-03276793