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Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression: a Double-blind, Randomized Controlled Trial
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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Tianjin Anding Hospital
Tianjin, China
Start Date
August 1, 2024
Primary Completion Date
September 1, 2025
Completion Date
February 1, 2026
Last Updated
February 27, 2026
100
ESTIMATED participants
deep Transcranial Magnetic Stimulation (dTMS) -active
DEVICE
deep Transcranial Magnetic Stimulation (dTMS) -sham
DEVICE
Lead Sponsor
Tianjin Anding Hospital
NCT04480918
NCT07172516
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