Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bipolar Depression
- Bipolar Disorder
- Bipolar I Disorder
- Bipolar II Disorder
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention 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 (Participant, Care Provider, Investigator)Masking Description: The device is operated using subject-specific links on a laptop. The active or sham identity of the links is prepared automatically and not known to study staff or participants.Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Both males and females
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 and proton Magnetic Resonance Spectroscopy. Following screening vis...
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 and proton Magnetic Resonance Spectroscopy. Following screening visits, study procedures include two visits, at least two weeks apart, during which subjects will complete brief mood scales, undergo 15 minutes of imaging, receive 20 minutes of Low Field Magnetic Stimulation treatment, and then return to the scanner to undergo another 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 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.
Tracking Information
- NCT #
- NCT03484494
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Brent P Forester, MD Mclean Hospital
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