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

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.

Study Overview

• Status: Recruiting
• Conditions: Bipolar Depression
• Intervention / Treatment: Device: deep Transcranial Magnetic Stimulation (dTMS) -active; Device: deep Transcranial Magnetic Stimulation (dTMS) -sham

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Li, Doctor; Phone Number: +86 022 88188006; Email: jieli@tjmhc.com

Study Locations

• China
  • Tianjin, China
    • Recruiting
    • Tianjin Anding Hospital
    • Contact: Jie Li, Doctor; Phone Number: +86 022 88188006; Email: jieli@tjmhc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Confirmed diagnosis of bipolar depression;

• age between 18 and 65 years;
• a 17-item Hamilton Depression Rating Scale (HDRS-17) score >= 17,
• a stable pharmacological regimen maintained for at least 4 weeks prior to the beginning of the treatment phase ;
• for participants who had previously received antidepressant therapy, a minimum 4-week washout period followed by re-evaluation.

Exclusion Criteria:

• a lifetime history of other psychiatric disorders, neurological diseases, or severe brain injury;
• receipt of electroconvulsive therapy, rTMS, transcranial direct current stimulation, transcranial alternating current stimulation, or other neurostimulation treatments within the previous 3 months;
• contraindications to magnetic stimulation, including epilepsy, cardiovascular disorders, or metallic implants in the head;
• the presence of hypomanic/manic symptoms at baseline or a score greater than 12 on the Young Mania Rating Scale (YMRS);
• pregnancy or lactation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dTMS group; 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).	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).
Sham Comparator: sham group; The sham stimulation was performed using the same procedures, with the sham coil.	Device: deep Transcranial Magnetic Stimulation (dTMS) -sham; The sham stimulation was performed using the same procedures, with the sham coil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change over time in the score of Hamilton Depression Rating Scale (HDRS-17).	The aim is to explore whether deep Transcranial Magnetic Stimulation (dTMS) combined with Pharmacological treatment could alleviate the severity of depressive symptoms as measured with HDRS-17 in bipolar depression after 4-week treatment. Hamilton Depression Rating Scale (HDRS-17) was used to evaluate the severity of symptoms of depression. Higher total score of the scale means more severe depressive symptoms.	baseline, week 2, week 4, week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change over time in the score of Hamilton Anxiety Rating Scale (HAMA)	The aim is to explore whether dTMS combined with Pharmacological treatment could alleviate the severity of anxious symptoms as measured with HAMA in bipolar depression after 4-week treatment. Hamilton Anxiety Rating Scale (HAMA) was used to evaluate the severity of symptoms of anxiety. Higher total score of the scale means more severe anxious symptoms.	baseline, week 2, week 4, week 8
The change of scores in MATRICS Consensus Cognitive Battery(MCCB)	The aim is to observe whether active-stimuli in addition to pharmacological treatment will improve the cognitive function as measured with the MATRICS Consensus Cognitive Battery (MCCB) after 4 weeks of treatment compared to sham-stimuli, and investigators assess the scale at baseline, week 4 and week 8.	baseline, week 4, week 8
Response and remission rates at weeks 2, week 4 and week 8 with HDRS-17.	The aim is to evaluate the response and remission rates at weeks 2, week 4 and week 8 with HDRS-17.	weeks 2, week 4 and week 8
The changes of levels of Brain Derived Neurotrophic Factor (BDNF) in peripheral blood	The aim is to investigate the change of Brain Derived Neurotrophic Factor (BDNF) level in peripheral blood as active stimuli in addition to regular medical treatment after 4 weeks of treatment compared to sham stimuli, and EDTA tubes were used to collect 5ml of peripheral blood at baseline, weeks 4, and 8 before feeding. The plasma was extracted after centrifugation, and the concentration of BDNF in plasma was detected by ELISA.	baseline, week 4, week 8
The change of scores of adverse events scale from baseline to week 4	The aim is to evaluate the adverse effects during the treatment.	baseline, week 4

Collaborators and Investigators

• Sponsor: Tianjin Anding Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): September 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Mood Disorders; Bipolar Disorder
• Other Study ID Numbers: dTMS-TJAH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No