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Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression (LFMSBioMGeri)

Primary Purpose

Bipolar Disorder, Bipolar Depression, Bipolar I Disorder

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Low Field Magnetic Stimulation

About this trial

This is an interventional basic science trial for Bipolar Disorder focused on measuring Geriatric, Low Field Magnetic Stimulation, Antidepressant, fMRI, MRS

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Dangerous or active suicidal ideation, as measured by the C-SSRS (see "Safety Measures" section), and physician evaluation.
Subjects meeting DSM-5 criteria for schizophrenia, schizoaffective disorder, or other psychotic disorders, or dementia.
Current mania as defined by a score of ≥ 10 on the Young Mania Rating Scale at screening.
Subject has an MMSE score ≤ 24.
Subject is pregnant or plans on becoming pregnant.
Subject has recent history (within 7 days of screening) of ECT or TMS treatment.
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).
Subject has any contraindication for MRI (i.e. Presence of a pacemaker, neurostimulator, or metal in head or neck).

Sites / Locations

McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Active first

Sham first

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in resting state brain activity measured by functional Magnetic Resonance Imaging.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03484494

First Posted

February 22, 2018

Last Updated

January 30, 2023

Sponsor

Mclean Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03484494

Brief Title

Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression

Acronym

LFMSBioMGeri

Official Title

Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 29, 2018 (Actual)

Primary Completion Date

August 30, 2023 (Anticipated)

Study Completion Date

August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mclean Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder

Keywords

Geriatric, Low Field Magnetic Stimulation, Antidepressant, fMRI, MRS

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

This is a sham controlled, randomized, double blinded crossover design study of immediate change to brain activity caused by Low Field Magnetic Stimulation.

Masking

ParticipantCare ProviderInvestigator

Masking Description

The device is operated using subject-specific links on a laptop. The active or sham identity of the links is prepared automatically and not known to study staff or participants.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active first

Arm Type

Other

Arm Description

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

Arm Title

Sham first

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Low Field Magnetic Stimulation

Intervention Description

Low Field Magnetic Stimulation is an application of a series of electromagnetic pulses to the brain through a small cylinder that the subject places the top of their head inside.

Primary Outcome Measure Information:

Title

Change in resting state brain activity measured by functional Magnetic Resonance Imaging.

Description

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects will have a diagnosis of Bipolar Disorder Type I or II, current episode depressed as measure by a MADRS ≥ 20. Subjects must be maintained on a stable dose of all psychotropic medications for a period of at least two weeks prior to screening. Subjects must be capable of providing informed consent. Subjects must permanently reside within a 2-hour drive of McLean Hospital. Subjects must be currently seen by a provider (psychiatrist, therapist, PCP) whose practice is within a 2-hour drive of McLean Hospital. Exclusion Criteria: Dangerous or active suicidal ideation, as measured by the C-SSRS (see "Safety Measures" section), and physician evaluation. Subjects meeting DSM-5 criteria for schizophrenia, schizoaffective disorder, or other psychotic disorders, or dementia. Current mania as defined by a score of ≥ 10 on the Young Mania Rating Scale at screening. Subject has an MMSE score ≤ 24. Subject is pregnant or plans on becoming pregnant. Subject has recent history (within 7 days of screening) of ECT or TMS treatment. 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). Subject has any contraindication for MRI (i.e. Presence of a pacemaker, neurostimulator, or metal in head or neck).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brent P Forester, MD

Organizational Affiliation

Mclean Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

McLean Hospital

City

Belmont

State/Province

Massachusetts

ZIP/Postal Code

02478

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression

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