Safety & efficacy of the sheets-type ELF-ELME therapy for depression

JRCT ID: jRCTs042240061

Registered date:25/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Depressive episode (DSM-5)
• Date of first enrollment: 25/07/2024
• Target sample size: 4
• Study type: Interventional
• Intervention(s): A sheets-type magnetic field stimulator incorporating a device that generates an extremely low frequency-weak magnetic fields is worn for two hours a day.

Outcome(s)

• Primary Outcome: Presence of adverse events

Secondary Outcome

Change in MADRS Scores
Change in Clinical Global Impression - Improvement (CGI-I)
Change in Clinical Global Impression - Severity (CGI-S)
Change in AI-MADRS
Wearing compliance rate
Comparison of efficacy and safety between head-worn and bedding-type devices using the dataset from a previous study (head-worn ELF-ELME generator, Asian J Psychiatr 96:104036, 2024) and the dataset from this study

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1. 18 to 75 years old, male and female
2. Patients who met the diagnostic criteria for a depressive episode according to DSM-5
3. Patients with a total MADRAS score of 22 or higher at baseline.
4. Patients whose written consent to participate in this study has been obtained from them.

Exclude criteria

1.Patients who met the following disorders according to the DSM-5 (delirium, dementia,amnesia and other cognitive disorders; schizophrenia and other psychotic disorders; mental retardation, etc.)
2.Patients who met the diagnostic criteria for substance abuse and substance dependence according to the DSM-5 within 24 weeks (excluding nicotine-related or caffeine-related disorders)
3.Patients with intracranial lesions with a history of or at risk for epilepsy/convulsive seizures. Patients who take drugs that risk lowering the convulsive threshold; tricyclic antidepressants, maprotiline, theophylline, methylphenidate, ketamine, etc.
4.Patients with a score of 4 or higher on item 10 (suicidal thoughts) of the MADRAS who are at high risk of suicide, or patients who are judged by the principal investigator to be at high risk of suicide.
5.Patients who have had a change in pharmacotherapy within 4 weeks
6.Patients who received other investigational drugs or standard psychotherapy such as cognitive behavioral therapy, interpersonal therapy, or psychoanalytic therapy within 16 weeks
7.Patients who received electroconvulsive therapy or high intensity light therapy within 16 weeks
8.Patients with serious complications such as diseases of the liver, kidney, blood, respiratory organs, digestive organs, cardiovascular system, metabolic and electrolyte abnormalities, or hypersensitivity
9.Patients with metals in close proximity to the stimulation site (cochlear implants, magnetic clips, stimulators such as deep brain stimulation or vagus nerve stimulation, intracranial titanium products, magnetized dentures or implants), cardiac pacemakers
10.pregnant patients
11.Patients who, for any other reason, are judged by the investigator to be inappropriate for participation in the study.

Related Information

• Primary Sponsor: Inada Toshiya
• Secondary Sponsor: Ono Kinji