Clinical trial NCT03484494: Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression
Official title: Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Bipolar Depression
Bipolar I Disorder
Bipolar II Disorder
Keywords: Geriatric
Low Field Magnetic Stimulation
Antidepressant
fMRI
MRS
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in resting state brain activity measured by functional Magnetic Resonance Imaging.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: David G Harper, PhD
role: PRINCIPAL_INVESTIGATOR
References: