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

Bipolar Depression Clinical Trial

— LFMS6tx  

Official title:

Low Field Magnetic Stimulation in Mood Disorders in Six Visits

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01557192
• Other study ID #: 2010-P-001097
• Status: Suspended
• Phase: Phase 1
• First received: March 14, 2012
• Last updated: April 12, 2016
• Start date: May 2010
• Est. completion date: May 2020

Study information

• Verified date: April 2016
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder
• Mood Disorders
• Unipolar Depression

Intervention

Device:
• Low Field Magnetic Stimulation Device
The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. Subjects will be given one 20 minute exposure to either the LFMS or sham electromagnetic field treatment.

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, 

References & Publications (2)

Carlezon WA Jr, Rohan ML, Mague SD, Meloni EG, Parsegian A, Cayetano K, Tomasiewicz HC, Rouse ED, Cohen BM, Renshaw PF. Antidepressant-like effects of cranial stimulation within a low-energy magnetic field in rats. Biol Psychiatry. 2005 Mar 15;57(6):571-6 — View Citation

Rohan M, Parow A, Stoll AL, Demopulos C, Friedman S, Dager S, Hennen J, Cohen BM, Renshaw PF. Low-field magnetic stimulation in bipolar depression using an MRI-based stimulator. Am J Psychiatry. 2004 Jan;161(1):93-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Montgomery-Asberg Depression Rating Scale (MADRS)score	MADRS scores will be compared between the baseline and week 3, one week after the final treatment.	at baseline and at week 3	No
Primary	Change in Positive-Negative Affect Scale (PANAS)score	PANAS scores will be compared between the baseline and week 3, one week after the final treatment.	at baseline and at one and at week 3	No
Secondary	Immediate mood improvement as measured by the difference in post and pre treatment PANAS ratings	PANAS scores will be assessed at baseline and before and after each treatment. There are six treatments (Monday, Wednesday and Friday for two weeks).	at baseline and immediately before and after each treatment, 6 treatments across 2 weeks	No
Secondary	Change in Montgomery-Asberg Depression Rating Scale (MADRS)score	MADRS scores will be compared between the baseline and week 4, two weeks after the final treatment.	at baseline and at week 4	No
Secondary	Change in Positive-Negative Affect Scale (PANAS)score.	PANAS scores will be compared between the baseline and week 4, two weeks after the final treatment.	at baseline and at one and at week 4	No