Completed

NCT Number: NCT05964777

rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder

Based on the individualized positioning technology of diffusion tensor imaging (DTI), the purpose of this study is to explore a new stimulation target and protocol for the treatment of bipolar disorder in remission through the repetitive transcranial magnetic stimulation(rTMS) and transcranial alternating current stimulation（tACS）under neuronavigation，verify whether there is abnormal functional connectivity and structural connections between the dorsolateral prefrontal cortex (dlpfc) and the dorsal anterior cingulate gyrus (dacc) related to cognitive impairment in bipolar disorder in remission, which will contribute to further understand the relevant neural pathway and mechanism.

Completed

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Key information

Conditions

Bipolar Disorder in Remission

Age range

14 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1. Age 14-45 years old, regardless of gender] 2.Meet DSM-V diagnostic criteria for bipolar depressive in remission 3.Young Mania Rating Scale (YMRS) ≤ 6 points; 4.Hamilton Depression Scale(HAMD-17)≤7 points; 5.Cognitive deficit questionnaire PDQ≥17 points; 6.Han nationality, right-handed; 7.More than 9 years of education.

Exclusion criteria

History of severe somatic or brain organic diseases and craniocerebral trauma;
Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination;
Those who do not cooperate or cannot effectively complete the experiment;
Drug, alcohol or other psychoactive substance abusers;
Pregnant, lactating or planned pregnancy;
ECT or rTMS or tACS treatment was performed within six months.

Treatment and study plan

rTMS（repeated transcranial magnetic stimulation）

Device

It is a therapeutic technique that utilizes repetitive pulsed magnetic fields applied externally to the skull to act on specific areas of the central nervous system. By altering the membrane potential of cortical neurons, it induces electric currents, which in turn affect brain metabolism and neural electrical activity, leading to a series of physiological and biochemical reactions.on of the therapeutic target.

The true stimulation group receives treatment at 100% of the rTMS intensity, while the sham stimulation group receives treatment at 20% of the rTMS intensity. All other parameters are the same. The treatment is conducted from Monday to Friday for a total of three weeks, amounting to 15 sessions.

tACS（transcranial alternating current stimulation）

Device

It is a non-invasive brain stimulation method that involves injecting sinusoidal currents to manipulate and entrain inherent neural oscillations, thereby modulating neural activity.

Under true stimulation, the stimulation electrode inputs 2mA, with a stimulation frequency of 40Hz. The other four return electrodes each output 0.5mA. The current fade-in and fade-out time is 10 seconds, and the stimulation duration is 30 minutes. For sham stimulation, the duration is the same as for true stimulation, but only the first and last 20 seconds have real electrical stimulation (i.e., 10 seconds of stimulation at the beginning and end, with no real stimulation during the intervening 29 minutes and 40 seconds).

Primary outcomes

thinc-it

Time frame: 0,3week

THINC-it test suites: Used primarily to assess cognitive dimensions such as executive function, learning and memory, attention, and processing speed in patients with BD. The assessment was conducted before and after treatment, and consisted of five main parts:Spotter,Symbol Check,Code Breaker,Trails test,PDQ-5-D

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

Efficacy and Safety of rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder: a Randomized, Double-blind, Sham Controlled Study

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jul 28, 2023
Registry last updated: May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.