The Efficacy and Safety of Task-state-based Temporal Interference Stimulation (TI) in the Treatment of Patients With Depression

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

This study intends to investigate the intervention efficacy of temporal interference stimulation (TI) on mood symptoms in depressed patients, as well as to explore the neuroimaging mechanisms of TI improvement in depressed patients using pre- and post-treatment magnetic resonance.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-50 years old, right-handed, and completed nine years of compulsory education;

Met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for depression;

HAMD-17≥18;

Subject was a first-time medication-naïve patient or had previously used antidepressant medication and was currently off medication for ≥2 weeks;

Disqualifiers

Co-morbid other psychiatric disorders, including bipolar disorder, affective psychiatric disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.;

Severe suicidal ideation or behavior;

History of a serious physical illness or a disease that may affect the central nervous system;

Neurologic disorders or risk of seizures such as previous cranial disorders, head trauma, abnormal electroencephalograms, magnetic resonance evidence of structural brain abnormalities, or a family history of epilepsy;

Trial design

Design model

Single group

Treatments tested in this trial

  • Temporal Interference Stimulation

    Device

    During the treatment period, all subjects were treated with a fixed time interference stimulation (TI) device at a frequency of 30 minutes twice a day, 5 days a week, for a total of 10 treatments. The output current intensity during treatment is 3.64 mA+4.36 mA.

Treatment groups

43 Participants
are divided into 1 treatment group
Group A: Temporal Interference StimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hamilton Depression Scale(HAMD-17)

The Hamilton Depression Scale(HAMD-17) was used to assess the extent of the patient's depressive episodes, with higher scores representing more severe depression, and this scale was used to monitor the patient's improvement in depression before and after treatment.

Time frame
0-5 days

Secondary outcomes

1

Montgomery-Asberg Depression Rating Scale(MADRS)

The Montgomery-Asberg Depression Rating Scale (MADRS) is used to reflect the effectiveness of antidepressant treatment and to monitor changes in a patient's condition. The scale is a stand-alone scale whose ratings are based on a clinical interview with questioning about symptoms that leads to a rating of depression severity.

Time frame
0-5 days
2

Beck Scale for Suicide Ideation (BSS)

The Beck Suicidal Ideation Scale was used to assess the patients' suicidal ideation.

Time frame
0-5 days

Other outcomes

Sponsors and contacts

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