LFMS: Initial Trial in Geriatric Bipolar Depression (LFMS)
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|ClinicalTrials.gov Identifier: NCT02707276|
Recruitment Status : Active, not recruiting
First Posted : March 14, 2016
Last Update Posted : August 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Depression Depressed Phase||Device: Active Low Field Magnetic Stimulation Device: Sham Low Field Magnetic Stimulation||Not Applicable|
The investigators have previously observed mood improvement in participants with bipolar depression in a population aged 21-60. Here the investigators hope to extend these results to a similar but new population, geriatric bipolar depression (GPD). In addition to the evaluation of the effect of multiple treatments, as well as observation of the duration of the effect after a delay of one week in this population, the investigators will assess whether this population presents any noticeable difference in tolerance or effect.
The protocol involves five treatments on consecutive days with one follow-up visit; this is a randomized, double-blind, sham-controlled study (subjects will either receive active treatment or sham treatment for all five treatment sessions).
The mechanisms of depression in a geriatric population may differ from those in a younger population. In particular, brain structures and connectivity have changed, and there is the increased risk of comorbid diagnoses such as dementia that might confound treatment and assessment. In this study the investigators hope to extend the findings of LFMS in the general population to directly address the treatment of bipolar depression in a geriatric population.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Low Field Magnetic Stimulation: Initial Trial in Geriatric Bipolar Depression|
|Actual Study Start Date :||September 7, 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Active LFMS
Active Low Field Magnetic Stimulation three 20 minute treatments, once per day for five consecutive days
Device: Active Low Field Magnetic Stimulation
Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
Other Name: Active LFMS
Sham Comparator: Sham LFMS
Sham Low Field Magnetic Stimulation three 20 minute treatments, once per day for five consecutive days
Device: Sham Low Field Magnetic Stimulation
The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
Other Name: Sham LFMS
- Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 1 week ]10 item interviewer rated assessment for depression
- Beck Depression Inventory (BDI) [ Time Frame: 30 minutes ]21 item self rating depression assessment
- Hamilton Anxiety Rating Scale (HARS) [ Time Frame: 1 week ]14 item interviewer rated assessment of anxiety
- Beck Anxiety Inventory (BAI) [ Time Frame: 30 minutes ]21 item self rating anxiety assessment
- CNS Vital Signs Cognitive Battery (CNSVS) [ Time Frame: 1 week ]Electronic multi-modular cognitive assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707276
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|Principal Investigator:||Brent Forester, M.D. MSc.||Mclean Hospital|