Low Field Magnetic Stimulation: Open Label Study.

Anxiety Clinical Trial

Official title:

Low Field Magnetic Stimulation: Open Label Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02542475
• Other study ID #: 2015P001011
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: September 3, 2015
• Last updated: April 12, 2016
• Start date: September 2015
• Est. completion date: August 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Mood Disorders

Intervention

Device:
• 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.

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 (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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No