Low Field Magnetic Stimulation in Bipolar Depression
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Mclean Hospital
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Positive and Negative Affect Scale
Study Overview
Brief Summary
Individuals with bipolar depression who had a particular kind of brain imaging reported improved mood after the imaging. This effect may be linked to the changing magnetic fields used during these magnetic resonance imaging studies. The current studies are designed to further explore the important parameters of this effect and to clarify the degree and duration of the mood effects.
Detailed Description
An initial study using proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) in bipolar depressed individuals was associated with reports of improved mood. These studies employed oscillating magnetic fields similar to those used in functional MRI (fMRI), but which differ from the usual fMRI scan in field direction, waveform frequency, and strength. As the abbreviation EP-MRSI is used to describe several relatively common MR sequences, the specific potential clinical procedure being used is referred to as low field magnetic stimulation or LFMS. Following these initial results, investigators are conducting studies to determine the critical variables in both subjects and treatment for optimal response. Studies are also underway to characterize the response of specific depression symptoms, the degree of response, and the duration of response.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Primary diagnosis of bipolar disorder.
- •Current depression.
Exclusion Criteria
- •Contraindication for MRI due to metal in eyes/head
- •Claustrophobia.
- •Inability to lie flat.
- •History of brain injury.
Arms & Interventions
Active EEP-MRSI treatment
20 minutes of active treatment with theEcho-Planar Magnetic Resonance Imaging (EP-MRSI)
Intervention: Echo-Planar Magnetic Resonance Imaging (EP-MRSI) (Device)
Sham comparator EP-MRSI
Sham treatment (20 minutes) with the Echo-Planar Magnetic Resonance Imaging (EP-MRSI).
Intervention: Echo-Planar Magnetic Resonance Imaging (EP-MRSI) (Device)
Outcomes
Primary Outcomes
Positive and Negative Affect Scale
Time Frame: pre/post-treatment
Secondary Outcomes
- Visual-Analog Scales(pre/post-treatment)
- Montgomery Asberg Depression Rating Scale (MADRS)(pre-treatment)
Investigators
Michael Rohan
Imaging Physicist
Mclean Hospital