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Low Field Magnetic Stimulation (LFMS) in Mood Disorders: 6 Treatments (LFMS6tx)

Primary Purpose

Bipolar Depression, Unipolar Depression

Status

Suspended

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Low Field Magnetic Stimulation Device

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring Depression, Bipolar Depression, LFMS, Electromagnetic Stimulation

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects MUST be significantly depressed, currently.
Subjects must not have serious physical illnesses, neurological diseases or dementias.
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.
Subject must have a Ham-D score > 17, YMRS score < 7 (bipolar subjects only), and a MADRS score > 18.
Subjects must be capable of providing informed consent.
Subjects must have an established residence and phone.
Subjects may be medicated or unmedicated.

Exclusion Criteria:

Dangerous or active suicidal ideation.
Pregnant or planning on becoming pregnant.
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).
Mixed mood state or rapid cycling.
Presence of a pacemaker, neurostimulator, or metal in head or neck.

Sites / Locations

McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active LFMS treatment

Sham LFMS treatment

Arm Description

20 minute exposure to the LFMS electromagnetic field treatment

20 minute exposure to either the sham (inactive) electromagnetic field treatment

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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).

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.

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.

Full Information

NCT ID

NCT01557192

First Posted

March 14, 2012

Last Updated

April 12, 2016

Sponsor

Mclean Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01557192

Brief Title

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

Acronym

LFMS6tx

Official Title

Low Field Magnetic Stimulation in Mood Disorders in Six Visits

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Suspended

Why Stopped

on hold indefinitely due to lack of funding

Study Start Date

May 2010 (undefined)

Primary Completion Date

May 2020 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mclean Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Depression, Unipolar Depression

Keywords

Depression, Bipolar Depression, LFMS, Electromagnetic Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active LFMS treatment

Arm Type

Active Comparator

Arm Description

20 minute exposure to the LFMS electromagnetic field treatment

Arm Title

Sham LFMS treatment

Arm Type

Placebo Comparator

Arm Description

20 minute exposure to either the sham (inactive) electromagnetic field treatment

Intervention Type

Device

Intervention Name(s)

Low Field Magnetic Stimulation Device

Other Intervention Name(s)

LFMS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Montgomery-Asberg Depression Rating Scale (MADRS)score

Description

MADRS scores will be compared between the baseline and week 3, one week after the final treatment.

Time Frame

at baseline and at week 3

Title

Change in Positive-Negative Affect Scale (PANAS)score

Description

PANAS scores will be compared between the baseline and week 3, one week after the final treatment.

Time Frame

at baseline and at one and at week 3

Secondary Outcome Measure Information:

Title

Immediate mood improvement as measured by the difference in post and pre treatment PANAS ratings

Description

PANAS scores will be assessed at baseline and before and after each treatment. There are six treatments (Monday, Wednesday and Friday for two weeks).

Time Frame

at baseline and immediately before and after each treatment, 6 treatments across 2 weeks

Title

Change in Montgomery-Asberg Depression Rating Scale (MADRS)score

Description

MADRS scores will be compared between the baseline and week 4, two weeks after the final treatment.

Time Frame

at baseline and at week 4

Title

Change in Positive-Negative Affect Scale (PANAS)score.

Description

PANAS scores will be compared between the baseline and week 4, two weeks after the final treatment.

Time Frame

at baseline and at one and at week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects MUST be significantly depressed, currently. Subjects must not have serious physical illnesses, neurological diseases or dementias. 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. Subject must have a Ham-D score > 17, YMRS score < 7 (bipolar subjects only), and a MADRS score > 18. Subjects must be capable of providing informed consent. Subjects must have an established residence and phone. Subjects may be medicated or unmedicated. Exclusion Criteria: Dangerous or active suicidal ideation. Pregnant or planning on becoming pregnant. 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). Mixed mood state or rapid cycling. Presence of a pacemaker, neurostimulator, or metal in head or neck.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael L. Rohan, Ph.D.

Organizational Affiliation

Mclean Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

McLean Hospital

City

Belmont

State/Province

Massachusetts

ZIP/Postal Code

02478

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

14702256

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. doi: 10.1176/appi.ajp.161.1.93.

Results Reference

result

PubMed Identifier

15780843

Citation

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. doi: 10.1016/j.biopsych.2004.12.011.

Results Reference

result

Learn more about this trial

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

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