Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression

Tianjin Anding Hospital

Status: Enrolling

Conditions: Bipolar Depression

Treatments: Device: deep Transcranial Magnetic Stimulation (dTMS) -sham; Device: deep Transcranial Magnetic Stimulation (dTMS) -active

Study type: Interventional

Funder types: Other

Identifiers

NCT06524505

dTMS-TJAH

Details and patient eligibility

About

The aim of this study is to evaluate the feasibility and efficacy of deep transcranial magnetic stimulation (dTMS) as an add-on treatment for bipolar depression. Meanwhile, we aim to evaluate the effect of dTMS on cognitive function of bipolar depressive patients. we hypothesize dTMS would improve depressive symptoms and cognitive function in bipolar disorder.

Full description

This is a randomized, double-blind, sham-controlled study to detect the effect of dTMS for treatment of bipolar depression. 100 participants were randomly assigned 1:1 to dTMS group or sham-control group. For both active and sham group, daily dTMS sessions were scheduled in a 5-day sequence for four consecutive weeks, and each session lasted 20minutes. Based on the original and stable medication, the active stimulation consisted of 55 18 Hz, 2 s trains at 120% MT intensity, with a between-train interval of 20 s (1980 pulses per day or 39 600 pulses per treatment). The sham stimulation was performed using the same procedures, with the sham coil.

Scale assessments are performed at baseline, week 2, week 4 and week 8. Collection of blood took place at baseline, week 4 and week 8.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Confirmed diagnosis of bipolar depression;

• Met standardized criteria for failure to achieve remission from pharmacological treatment in the current illness episode;
• Pharmacological treatment maintained unchanged for the four weeks preceding rTMS application；
• Able to read, verbalize understanding and voluntarily sign the informed consent form prior to performance of any study-specific procedures or assessments

Exclusion criteria

• Previous treatment with rTMS;
• Ferromagnetic material close to the head;
• Cardiac pacemaker and/or implanted electronic device;
• The presence of neurological disorders (uncontrolled epilepsy, previous significant head injuries, brain surgery);
• Pregnancy or lactation;
• Significant medical and/or psychiatric comorbidities;
• Substance abuse in the last three months (not including caffeine or nicotine);
• Acute psychosis;
• Acute suicidality;
• Patient refuses to sign consent for participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

dTMS group

Experimental group

Description:

Participants receive active stimulation with H1 coil, consisting of 55 18 Hz, 2 s trains at 120% MT intensity, with a between-train interval of 20 s ,1980 pulses per day. The subjects were stimulated every day for 4 weeks (except weekends).

Treatment:

Device: deep Transcranial Magnetic Stimulation (dTMS) -active

sham group

Sham Comparator group

Description:

The sham stimulation was performed using the same procedures, with the sham coil.

Treatment:

Device: deep Transcranial Magnetic Stimulation (dTMS) -sham