Active — Not RecruitingNot Applicable

Improving Brain Stimulation Through Imaging

United States54 participantsStarted 2019-09-30

Plain-language summary

Repetitive pulse transcranial magnetic stimulation (rTMS) is a noninvasive treatment that involves stimulating the brain; however, treatment benefit depends on placing a TMS coil in the correct place on the head to reach critical brain regions below. Clinicians typically use scalp-based targeting, a process in which rather than using MRI guidance to target brain regions for stimulation, they use landmarks on the scalp. Several researchers, including the investigators' lab, showed that the current scalp-based targeting techniques do not position stimulation above the correct brain region, and patients fail to respond. The investigators propose to improve clinical scalp-based targeting by comparing it to MRI guided targeting. The most common clinical population receiving rTMS therapy is depressed patients. The investigators' plan is to study the accuracy of certain scalp-based rules in patients with depression. Accurate brain stimulation targeting is critical for effective rTMS therapy. For participants who are not undergoing rTMS therapy who have COVID-19 distress, we are offering a combined home-based neuromodulation (transcranial electrical stimulation) and focused psychotherapy program dedicated to improving the same outcome measure, quality of life. Transcranial electrical stimulation (tES) stimulates the brain over a large region; however, we are able to model with brain imaging which brain regions receive the strongest stimulation. Our goal is still to examine stimulation precision, but we will test whether strength of tES in the same brain regions that rTMS is targeting will also lead to improved quality of life. We will also carefully assess whether it is possible to measure healthy functioning, an outcome in the rTMS study, because sheltering in place may reduce activities and thus distort our measure. We will also test whether our psychotherapy intervention will mitigate this effect and, if so, we may make it available to all those depressed Veterans in whom we're studying the effect of neuromodulation on functioning.

Who can participate

Age range18 Years – 89 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Cohort 1: Capacity and willingness to participant in TMS, and fMRI as well as satisfying criteria for diagnosis. * Between 18 and 89 years of age. * Ability to obtain a Motor Threshold (MT) with single pulse TMS * Ability to safely and comfortably undergo an MRI and TMS * Able to read, verbalize, understand and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments * Depression (PHQ-9 \>= 10 and functional impairment present indicated with "difficulty" question OR sufficiently depressed to be enrolled in rTMS therapy) * Confirmed diagnosis of Major Depressive Disorder (MDD) * Can maintain all existing treatments (e.g. psychopharmacology, psychotherapy, etc.,) throughout course of the three sessions (psychological / functional assessments, MRI, and TMS), with modifications only as needed for clinical management * Is a Veteran Cohort 2: * Between 18 and 89 years of age * Ability to safely and comfortably undergo an MRI and tES * Ability to read, verbalize, understand, and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments * Depression (PHQ-9 \>= 10) and endorse that the COVID-19 pandemic has worsened their depression OR have a score on the COVID Stress Scale (CSS) on any item of 3 or greater indicating stressor is "very" or "often" a problem will allow the Veteran to enter the study Exclusion Criteria: * Participants who can not sa…

What they're measuring

World Health Organization Disability Assessment Schedule 2.0

Timeframe: Baseline

Veterans RAND 36-Item

Timeframe: Baseline

Trial details

NCT IDNCT03851380

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeOBSERVATIONAL

Primary completion2024-07-31