Low Field Magnetic Stimulation (LFMS) in Mood Disorders: 6 Treatments

Phase 1

Suspended

• Conditions: Unipolar Depression; Bipolar Depression
• Interventions: Device: Low Field Magnetic Stimulation Device

• Registration Number: NCT01557192
• Lead Sponsor: Mclean Hospital

Brief Summary

To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS) as an antidepressant treatment in subjects with mood disorders.

Detailed Description

The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. The field and timing parameters of the LFMS pulses, such as pulse timing, duration, frequency, and electric and magnetic field distribution and direction are different from other neurostimulation methods.

The mechanism of action for the antidepressant effects of LFMS is hypothesized to be an effect on dendritic or synaptic activity in the cortex, brought about by low level electrical stimulation applied with particular timing. This is analogous to the synaptic effects of pharmaceutical antidepressants in providing a "boost" to synapses in certain brain regions.

Previous investigations of LFMS included depressed subjects with bipolar disorder. This study will evaluate the antidepressant effects of multiple LFMS treatments in bipolar disorder and major depressive disorder.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2012-03-14
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-19
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-13
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Subjects MUST be significantly depressed, currently.
2. Subjects must not have serious physical illnesses, neurological diseases or dementias.
3. Subjects will meet DSM-IV criteria for Bipolar Disorder Type I or II, Major Depressive Disorder, Post Traumatic Stress Disorder, or Obsessive Compulsive Disorder, and be currently depressed.
4. Subject must have a Ham-D score > 17, YMRS score < 7 (bipolar subjects only), and a MADRS score > 18.
5. Subjects must be capable of providing informed consent.
6. Subjects must have an established residence and phone.
7. Subjects may be medicated or unmedicated.

Exclusion Criteria

1. Dangerous or active suicidal ideation.
2. Pregnant or planning on becoming pregnant.
3. Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month).
4. Mixed mood state or rapid cycling.
5. Presence of a pacemaker, neurostimulator, or metal in head or neck.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active LFMS treatment	Low Field Magnetic Stimulation Device	20 minute exposure to the LFMS electromagnetic field treatment
Sham LFMS treatment	Low Field Magnetic Stimulation Device	20 minute exposure to either the sham (inactive) electromagnetic field treatment

Primary Outcome Measures

Name	Time	Method
Change in Montgomery-Asberg Depression Rating Scale (MADRS)score	at baseline and at week 3	MADRS scores will be compared between the baseline and week 3, one week after the final treatment.
Change in Positive-Negative Affect Scale (PANAS)score	at baseline and at one and at week 3	PANAS scores will be compared between the baseline and week 3, one week after the final treatment.

Secondary Outcome Measures

Name	Time	Method
Immediate mood improvement as measured by the difference in post and pre treatment PANAS ratings	at baseline and immediately before and after each treatment, 6 treatments across 2 weeks	PANAS scores will be assessed at baseline and before and after each treatment. There are six treatments (Monday, Wednesday and Friday for two weeks).
Change in Positive-Negative Affect Scale (PANAS)score.	at baseline and at one and at week 4	PANAS scores will be compared between the baseline and week 4, two weeks after the final treatment.
Change in Montgomery-Asberg Depression Rating Scale (MADRS)score	at baseline and at week 4	MADRS scores will be compared between the baseline and week 4, two weeks after the final treatment.

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States