Mood DisordersPhase 1/2NCT02542475
Low Field Magnetic Stimulation: Open Label Study.
A Phase 1/2 study testing Low Field Magnetic Stimulation in people with Mood Disorders and Anxiety, run by Mclean Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mood Disorders, Anxiety
- What is being tested?
- Low Field Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Aug 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Low Field Magnetic Stimulation
- Medical subject headings
- Mood Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Field Magnetic StimulationDevice
Also called LFMS
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.
| Study group | Role | What they receive |
|---|---|---|
| Mood Improvement | Experimental | Mood change with daily Low Field Magnetic Stimulation in participants suffering from affective disorders and/or anxiety Receives: Device: Low Field Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in daily mood after LFMS treatment using the Beck Depression Inventory (BDI)
Daily change in the BDI before and after each LFMS treatment
Measured: 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
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2019 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Rohan, Mclean Hospital
- Investigators
- Michael L Rohan, Ph.D., Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542475
- Sponsor's protocol ID
- 2015P001011
- Status last verified
- Apr 2016
- First submitted
- 3 Sep 2015
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24331545
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Field Magnetic Stimulation: Open Label Study.
- ClinicalTrials.gov ID
- NCT02542475
- Acronym / sponsor ID
- 2015P001011
- Conditions
- Mood Disorders, Anxiety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mood Improvement | Experimental | Device: Low Field Magnetic StimulationMood change with daily Low Field Magnetic Stimulation in participants suffering from affective disorders and/or anxiety |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Field Magnetic StimulationAlso: LFMSThe 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. | Device | Mood Improvement |
Primary outcome
Changes in daily mood after LFMS treatment using the Beck Depression Inventory (BDI)
Time frame: 24 hrs
Daily change in the BDI before and after each LFMS treatment
Change in mood after 5 days of LFMS treatment using the Hamilton Depression Rating Scale (HDRS)
Time frame: 5 days
Change in HDRS from before the first treatment to after the 5th (final) treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Background: PubMed 24331545Rohan 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.
Related trials for Mood Disorders
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Depressive Disorder, Major, Inflammation
RecruitingObservational study
Tracking Response to Antidepressants in Advance of Investigational Trials
Major Depressive Disorder
Active, not recruiting
Functional Remediation for Older Adults With Bipolar Disorder
Bipolar Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael L Rohan, Ph.D. principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low Field Magnetic Stimulation in people with Mood Disorders and Anxiety, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in daily mood after LFMS treatment using the Beck Depression Inventory (BDI) (time frame: 24 hrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02542475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.