Magnetic Stimulation for Bipolar Depression (LFMSBioMGeri Trial)

Recruiting in Palo Alto (17 mi)

Brent Forester MD - TECHNOLOGY & AGING ...

Overseen ByDavid G Harper, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mclean Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?The protocol involves functional Magnetic Resonance Imaging acquisitions immediately before and after Low Field Magnetic Stimulation treatment on two separate days in a sham controlled, randomized trial, in order to assess the physiologic effects of Low Field Magnetic Stimulation on brain function in a geriatric population with bipolar depression.

Eligibility Criteria

This trial is for older adults living near McLean Hospital with Bipolar Disorder Type I or II, currently depressed (MADRS ≥ 20), and stable on medications for at least two weeks. They must be able to consent and not have suicidal thoughts, mania, MRI contraindications, recent ECT/TMS treatment, substance abuse history, or other psychotic disorders/dementia.

Participant Groups

The study tests the effects of Low Field Magnetic Stimulation on brain function in geriatric patients with bipolar depression using before-and-after brain scans. It's a sham controlled trial where participants are randomly chosen to receive either the real treatment or a placebo.

2Treatment groups

Experimental Treatment

Group I: Sham firstExperimental Treatment1 Intervention

Subjects receive sham Low Field Magnetic Stimulation in the first imaging visit and active in the second.

Group II: Active firstExperimental Treatment1 Intervention

Subjects receive active Low Field Magnetic Stimulation in the first imaging visit and sham in the second.