Effects of Deep Transcranial Magnetic Stimulation on Cognitive Function in Bipolar Depression: A Randomized Controlled Trial Using the MATRICS Consensus Cognitive Battery.
Lijun Chu, Xiaoju Jia, Ping Gao...
https://pubmed.ncbi.nlm.nih.gov/41788133Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06524505
Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression: a Double-blind, Randomized Controlled Trial
Led by Tianjin Anding Hospital · Updated on 2026-02-27
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of deep transcranial magnetic stimulation (dTMS) as an additional treatment for people with bipolar depression. The study aims to assess whether dTMS can improve depressive symptoms and cognitive function in these patients. This is a randomized, double-blind, sham-controlled trial involving 100 participants to evaluate the effects and tolerability of dTMS. Participants are randomly assigned to receive either active dTMS or sham (placebo) stimulation. Both groups undergo daily 20-minute sessions for five days each week over four weeks, except weekends. The active treatment uses the H1 coil delivering 55 trains of 18 Hz stimulation at 120% motor threshold, totaling 1980 pulses per session. The sham group follows the same schedule but with a sham coil that mimics the procedure without active stimulation. Throughout the study, participants have assessments at the start, after 2 weeks, 4 weeks, and 8 weeks. These include depression and anxiety rating scales, cognitive tests, and blood samples to measure brain-derived neurotrophic factor levels. Researchers will monitor symptom changes, cognitive function, and any side effects. The study concludes in February 2026, with ongoing evaluation of treatment response and safety.
CONDITIONS
Brief Title
Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of bipolar depression
- Age between 18 and 65 years
- A 17-item Hamilton Depression Rating Scale (HDRS-17) score of 17 or higher
- Stable medication regimen maintained for at least 4 weeks before treatment
- Minimum 4-week washout and re-evaluation after previous antidepressant therapy
You will not qualify if you...
- History of other psychiatric disorders, neurological diseases, or severe brain injury
- Received electroconvulsive therapy, rTMS, transcranial direct or alternating current stimulation, or other neurostimulation treatments within 3 months
- Contraindications to magnetic stimulation such as epilepsy, cardiovascular disorders, or metallic implants in the head
- Presence of hypomanic or manic symptoms at baseline or a Young Mania Rating Scale (YMRS) score greater than 12
- Pregnancy or lactation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 weeks
Participants receive daily deep Transcranial Magnetic Stimulation (dTMS) sessions or sham stimulation over four weeks, Monday through Friday. Each session lasts about 20 minutes.
20 visits (Monday to Friday for 4 weeks)
Follow-up
Duration - 4 weeks
Participants complete assessments to evaluate treatment effects and cognitive changes after the treatment period.
3 visits (at week 4, week 8, and week 8 blood collection)
Trial Site Locations
Total: 1 location
1
Tianjin Anding Hospital
Tianjin, China
Actively Recruiting
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Research Team
J
Jie Li, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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