A Randomized Controlled Study on the Efficacy and Safety of Task-activated rTMS in Improving Cognitive Function in Patients With Bipolar Disorder

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

1. To clarify the efficacy and safety of task-based repetitive transcranial magnetic stimulation (rTMS) on cognitive function in patients with stable bipolar disorder. 2. To analyze the therapeutic mechanism of transcranial magnetic stimulation based on magnetic resonance imaging and explore the abnormal regulation mechanism of cognitive neural circuits.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 45
Healthy Volunteers: f
View:

• Aged 14 to 45 years, right-handed;

• Meet the diagnostic criteria for bipolar disorder in the stable remission period of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);

• Stable medication treatment;

• Clinical remission for more than three months, Young Mania Rating Scale (YMRS) ≤ 6 points Hamilton Depression Rating Scale 17 (HDRS 17) score ≤ 7 points;

• Cognitive impairment on the Cognitive Deficit Questionnaire (PDQ) ≥ 17 points;

• Fully understand the transcranial magnetic stimulation treatment, be willing to actively cooperate with the treatment, and sign the informed consent.

Locations
Other Locations
China
The First Affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Shaohua Hu
dorhushaohua@zju.edu.cn
086-13957162903
Time Frame
Start Date: 2024-12-20
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 82
Treatments
Experimental: rTMS active group and active cognitive training
Receive 10 Hz, 20 minutes of active rTMS stimulation; 20 minutes of cognitive training at the same time
Sham_comparator: rTMS active group and sham cognitive training
10 Hz, 20 minutes of active rTMS stimulation; 20 minutes of perform simple judgment training at the same time
Sham_comparator: rTMS sham group and active cognitive training
10 Hz, 20 minutes of low-intensity rTMS stimulation; 20 minutes of cognitive training at the same time
Sham_comparator: rTMS sham group and sham cognitive training
10 Hz, 20 minutes of low-intensity rTMS stimulation; perform simple judgment training for 20 minutes at the same time
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital of Zhejiang University

This content was sourced from clinicaltrials.gov