NCT03484494Active, not recruiting
Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 22 Feb 2018
- Start date
- 29 May 2018
- Primary completion date
- 21 Jul 2026
- Lead sponsor
- Mclean Hospital
- Diseases
- Bipolar disorder
- NCT number
- NCT03484494
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 29 May 2018 to the primary completion date, 21 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects meeting DSM-5 criteria for schizophrenia, schizoaffective disorder, or other psychotic disorders, or dementia.
- 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).
Other
- Dangerous or active suicidal ideation, as measured by the C-SSRS (see "Safety Measures" section), and physician evaluation.
- 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 any contraindication for MRI (i.e. Presence of a pacemaker, neurostimulator, or metal in head or neck).
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McLean Hospital Coordinator of this site? Confirm its status | Belmont | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.