Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression (NCT03484494) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression
United States40 participantsStarted 2018-05-29
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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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).
What they're measuring
1
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.