NCT06524505

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

Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression: a Double-blind, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tianjin Anding Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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% motor threshold (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.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DEVICE	deep Transcranial Magnetic Stimulation (dTMS) -active	with the H1-coil device included 20-min sessions of 18 Hz (2-s trains separated by 20-s inter-train intervals, 55 trains totaling 1980 pulses/session).
DEVICE	deep Transcranial Magnetic Stimulation (dTMS) -sham	The sham stimulation was performed using the same procedures, with the sham coil.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-09-01
• Completion: 2026-02-01
• First posted: 2024-07-29
• Last updated: 2026-02-27

Locations

1 site across 1 country: China