Low Field Magnetic Stimulation: Open Label Study.



Status:Active, not recruiting
Conditions:Anxiety, Anxiety, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2015
End Date:August 2020

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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.

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.

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).
We found this trial at
1
site
115 Mill St
Belmont, Massachusetts 02478
(617) 855-2000
McLean Hospital McLean Hospital is a comprehensive psychiatric hospital committed to providing easy access to...
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from
Belmont, MA
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