Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression

Bipolar Disorder Clinical Trial

— LFMSBioMGeri  

Official title:

Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03484494
• Other study ID #: 2017P002783
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 29, 2018
• Est. completion date: August 30, 2023

Study information

• Verified date: January 2023
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 population with bipolar depression.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Bipolar I Disorder
• Bipolar II Disorder
• Depression
• Depressive Disorder
• Disease

Intervention

Device:
• Low Field Magnetic Stimulation
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.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.