Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression

NCT03484494 | Active Not Recruiting FDA Device

• 1 other identifier: 2017P002783
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Depression; Bipolar I Disorder; Bipolar II Disorder; Bipolar Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (2)

Active first

OTHER

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

Device: Low Field Magnetic Stimulation

Sham first

OTHER

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

Device: Low Field Magnetic Stimulation

Interventions

Low Field Magnetic Stimulation DEVICE

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.

Active first; Sham first

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• David G Harper, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David Harper, PhD

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

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 30, 2018
• Study Start: May 29, 2018
• Primary Completion (Estimated): July 21, 2026
• Study Completion (Estimated): July 21, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)