Low Field Magnetic Stimulation: Open Label Study.

NCT ID: NCT02542475

Last Updated: 2016-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2020-08-31

Brief Summary

To assess the effects of daily LFMS treatments for those suffering from affective or anxiety symptoms. We hypothesize a reduction in affective and or anxiety symptoms after active treatment over the period of one week, with improvement through the following week.

Detailed Description

The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain. 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. LFMS electromagnetic fields are significantly weaker (< 100x) than those used in ECT and rTMS.

LFMS was discovered at McLean Hospital and has thus far been studied as an experimental antidepressant treatment at McLean Hospital. LFMS is also being studied at Massachusetts General Hospital and 5 other hospitals in an NIH sponsored trial (RAPID) as well as in studies at Cornell-Weill School of Medicine. The mechanism of action for the antidepressant effects of LFMS is hypothesized to be an interaction between the electromagnetic fields and neurons in cortical regions, brought about by low level electrical stimulation applied with particular timing.

The current study proposes to assess the effects of daily LFMS treatments in participants suffering from affective disorders and/or anxiety. This is an open-label study. All subjects will receive active LFMS treatments. Potential subjects will be referred to the study by their clinicians and will be pre-screened by phone.

Conditions

Mood Disorders; Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mood Improvement

Mood change with daily Low Field Magnetic Stimulation in participants suffering from affective disorders and/or anxiety

Group Type: EXPERIMENTAL

Low Field Magnetic Stimulation

Intervention Type: DEVICE

The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain. 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. LFMS electromagnetic fields are significantly weaker (\< 100x) than those used in ECT and rTMS.

Interventions

Low Field Magnetic Stimulation

The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain. 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. LFMS electromagnetic fields are significantly weaker (\< 100x) than those used in ECT and rTMS.

Intervention Type: DEVICE

Other Intervention Names

LFMS

Eligibility Criteria

Inclusion Criteria

1. Subjects will be accepted into the study upon written referral by a McLean clinician or outside psychiatrist.

2. Subjects will be men or women over the age of 18.

3. Subjects must have failed at least one FDA approved treatment before enrolling in this study.

4. Subjects must be capable of providing informed consent.

5. Subjects must have either a Hamilton Depression Rating Scale (HDRS) score > 14 indicating moderate depression or Hamilton Anxiety Rating Scale (HARS) score > 18 indicating moderate anxiety.

Exclusion Criteria

1. Dangerous or active suicidal ideation.

2. Pregnant or planning on becoming pregnant.

3. Recent history (within 3 days) of ECT or TMS treatment.

4. Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no history of dependence in last year, no drug use within last month, other than marijuana use).

5. Current psychosis.

6. Contraindications for MRI: Presence of a pacemaker, neurostimulator, or metal in head or neck.

7. "Do Not Resuscitate" order in place (to avoid risk in the case of non-study-related accidents).

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michael Rohan

Imaging Physicist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael L Rohan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

References

Rohan ML, Yamamoto RT, Ravichandran CT, Cayetano KR, Morales OG, Olson DP, Vitaliano G, Paul SM, Cohen BM. Rapid mood-elevating effects of low field magnetic stimulation in depression. Biol Psychiatry. 2014 Aug 1;76(3):186-93. doi: 10.1016/j.biopsych.2013.10.024. Epub 2013 Nov 12.

Reference Type: BACKGROUND

PMID: 24331545 (View on PubMed)

Other Identifiers

2015P001011

Identifier Type: -

Identifier Source: org_study_id