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rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05964777
Enrollment
116
Registered
2023-07-28
Start date
2023-07-01
Completion date
2024-08-03
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder in Remission

Keywords

repetitive transcranial magnetic stimulation,Transcranial alternating current stimulation,diffusion tensor imaging,bipolar disorder

Brief summary

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.

Interventions

DEVICErTMS(repeated transcranial magnetic stimulation)

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.

DEVICEtACS(transcranial alternating current stimulation)

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).

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
14 Years to 45 Years
Healthy volunteers
No

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

1. History of severe somatic or brain organic diseases and craniocerebral trauma; 2. Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination; 3. Those who do not cooperate or cannot effectively complete the experiment; 4. Drug, alcohol or other psychoactive substance abusers; 5. Pregnant, lactating or planned pregnancy; 6. ECT or rTMS or tACS treatment was performed within six months.

Design outcomes

Primary

MeasureTime frameDescription
thinc-it0,3weekTHINC-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

Countries

China

Contacts

STUDY_DIRECTORShaoHua Hu, MD

Zhejiang University

STUDY_DIRECTORChina Zhejiang

The First Affiliated Hospital of Zhejiang University [Recruiting] Hangzhou, Zhejiang, China, 310000 Contact: ShaoHua Hu, MD 13957162903 dorhushaoh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026