Low Field Magnetic Stimulation: Open Label Study.

NCT02542475 | Unknown Phase 1

• 1 other identifier: 2015P001011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mood Disorders; Anxiety

Outcome Measures

Primary Outcomes (2)

• Changes in daily mood after LFMS treatment using the Beck Depression Inventory (BDI)

  Daily change in the BDI before and after each LFMS treatment

  24 hrs

• Change in mood after 5 days of LFMS treatment using the Hamilton Depression Rating Scale (HDRS)

  Change in HDRS from before the first treatment to after the 5th (final) treatment

  5 days

Study Arms (1)

Mood Improvement

EXPERIMENTAL

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

Device: Low Field Magnetic Stimulation

Interventions

Low Field Magnetic Stimulation 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.

Also known as: LFMS

Mood Improvement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be accepted into the study upon written referral by a McLean clinician or outside psychiatrist.
• Subjects will be men or women over the age of 18.
• Subjects must have failed at least one FDA approved treatment before enrolling in this study.
• Subjects must be capable of providing informed consent.
• 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.

You may not qualify if:

• Dangerous or active suicidal ideation.
• Pregnant or planning on becoming pregnant.
• Recent history (within 3 days) of ECT or TMS treatment.
• 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).
• Current psychosis.
• Contraindications for MRI: Presence of a pacemaker, neurostimulator, or metal in head or neck.
• "Do Not Resuscitate" order in place (to avoid risk in the case of non-study-related accidents).

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (1)

• 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.

  PMID: 24331545 BACKGROUND

MeSH Terms

Conditions

Mood Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Michael L Rohan, Ph.D.

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Imaging Physicist

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 7, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2020
• Last Updated: April 13, 2016

Record last verified: 2016-04

Locations

US (1)