Improving Brain Stimulation Through Imaging

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.

Conditions

• Depression
• Depressive Disorder, Treatment-Resistant
• COVID Stress

Interventions

BEHAVIORAL

Psychological / Functional Assessment

Psychological and functional assessment battery to characterize participants.

OTHER

Structural and Functional MRI

Structural and functional magnetic resonance imaging session.

DEVICE

Transcranial Magnetic Brain Stimulation and MR Image Guidance

MRI guided transcranial magnetic stimulation and measurement of targeting accuracy.

DEVICE

Transcranial Electrical Stimulation (tES)

Home-based Transcranial Direct Current Stimulation

Sponsors & Collaborators

• Providence VA Medical Center

  collaborator FED

• Atlanta VA Medical Center

  collaborator FED

• VA Office of Research and Development

  lead FED

Principal Investigators

• Allyson C Rosen, PhD · VA Palo Alto Health Care System, Palo Alto, CA

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-30

Primary Completion

2024-07-31

Completion

2026-05-01

FDA Device

Yes

Countries

• United States

Study Locations