Bipolar DisorderLFMSBioMGeriNCT03484494
Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression
A study testing Low Field Magnetic Stimulation in people with Bipolar Disorder and Bipolar Depression, run by Mclean Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder
- What is being tested?
- Low Field Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2018to 21 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Low Field Magnetic Stimulation
- Keywords
- Geriatric, Low Field Magnetic Stimulation, Antidepressant, fMRI, MRS
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Field Magnetic StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active first | Other | Subjects receive active Low Field Magnetic Stimulation in the first imaging visit and sham in the second. Receives: 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. Receives: Device: Low Field Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start29 May 2018
- Primary completion21 Jul 2026 (estimated)
- Study completion21 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David G. Harper, Ph.D., Mclean Hospital
- Investigators
- David G Harper, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484494
- Sponsor's protocol ID
- 2017P002783
- Acronym
- LFMSBioMGeri
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2018
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression
- ClinicalTrials.gov ID
- NCT03484494
- Acronym / sponsor ID
- LFMSBioMGeri / 2017P002783
- Keywords
- Geriatric, Low Field Magnetic Stimulation, Antidepressant, fMRI, MRS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 21 Jul 2026 (estimated)
- Study completion
- 21 Jul 2026 (estimated)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active first | Other | Device: Low Field Magnetic StimulationSubjects receive active Low Field Magnetic Stimulation in the first imaging visit and sham in the second. |
| Sham first | Other | Device: Low Field Magnetic StimulationSubjects receive sham Low Field Magnetic Stimulation in the first imaging visit and active in the second. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Field Magnetic StimulationLow 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. | Device | Active first, Sham first |
Primary outcome
Change in resting state brain activity measured by functional Magnetic Resonance Imaging.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G Harper, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Field Magnetic Stimulation in people with Bipolar Disorder and Bipolar Depression, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resting state brain activity measured by functional Magnetic Resonance Imaging. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.