Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression

Not Applicable

Active, not recruiting

• Conditions: Bipolar Depression; Bipolar Disorder; Bipolar I Disorder; Bipolar II Disorder
• Interventions: Device: Low Field Magnetic Stimulation

• Registration Number: NCT03484494
• Lead Sponsor: Mclean Hospital

Brief Summary

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.

Detailed Description

In this study, the investigators will examine changes in brain activity from Low Field Magnetic Stimulation in subjects over the age of 50 with bipolar disorder who are currently depressed using functional Magnetic Resonance Imaging. Following screening visits, study procedures include two visits, at least two weeks apart, during which subjects will complete brief mood scales, undergo up to 15 minutes of imaging, receive 20 minutes of Low Field Magnetic Stimulation treatment, and then return to the scanner to undergo up to 15 minutes of imaging procedures. Due to the crossover design, subjects receiving active treatment during the first visit will receive sham treatment during the second visit; subjects receiving sham treatment during the first visit will receive active treatment during the second visit. A follow-up phone call will occur at least two days after each imaging/treatment visit. The main endpoint of this study is the observation of changes in resting state functional Magnetic Resonance Imaging activity in post-treatment acquisitions as compared to pre-treatment acquisitions.

Study Timeline

• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-03-30
• Study Start: 2018-05-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29
• Primary Completion: 2025-05-21
• Study Completion: 2025-05-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Subjects will have a diagnosis of Bipolar Disorder Type I or II, current episode depressed as measure by a MADRS ≥ 20.
2. Subjects must be maintained on a stable dose of all psychotropic medications for a period of at least two weeks prior to screening.
3. Subjects must be capable of providing informed consent.
4. Subjects must permanently reside within a 2-hour drive of McLean Hospital.
5. Subjects must be currently seen by a provider (psychiatrist, therapist, PCP) whose practice is within a 2-hour drive of McLean Hospital.

Exclusion Criteria

1. Dangerous or active suicidal ideation, as measured by the C-SSRS (see "Safety Measures" section), and physician evaluation.
2. Subjects meeting DSM-5 criteria for schizophrenia, schizoaffective disorder, or other psychotic disorders, or dementia.
3. Current mania as defined by a score of ≥ 10 on the Young Mania Rating Scale at screening.
4. Subject has an MMSE score ≤ 24.
5. Subject is pregnant or plans on becoming pregnant.
6. Subject has recent history (within 7 days of screening) of ECT or TMS treatment.
7. Subject has recent history of substance abuse (cannot meet DSM-5 criteria for substance abuse, no significant drug abuse within last 3 months, no history of dependence in last year, no drug use within last month, other than marijuana use).
8. Subject has any contraindication for MRI (i.e. Presence of a pacemaker, neurostimulator, or metal in head or neck).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active first	Low Field Magnetic Stimulation	Subjects receive active Low Field Magnetic Stimulation in the first imaging visit and sham in the second.
Sham first	Low Field Magnetic Stimulation	Subjects receive sham Low Field Magnetic Stimulation in the first imaging visit and active in the second.

Primary Outcome Measures

Name	Time	Method
Change in resting state brain activity measured by functional Magnetic Resonance Imaging.	Resting state functional Magnetic Resonance Imaging data are acquired 4 times, twice within one hour during imaging visit 1 and twice within one hour during imaging visit 2 which occurs at least two weeks later.	Comparison of change in brain activity occurring over the time of treatment, compared between active and sham treatment visits. This is assessed by combining pre and post treatment measures made during active and sham treatment visits using the following formula: (post active treatment - pre active treatment) - ( post sham - pre sham). The brain activity is measured using blood oxygenation level dependent image of brain activity acquired in the resting state using functional Magnetic Resonance Imaging.

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States