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rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder

Primary Purpose

Bipolar Disorder in Remission

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder in Remission focused on measuring repetitive transcranial magnetic stimulation，Transcranial alternating current stimulation，diffusion tensor imaging，bipolar disorder

Eligibility Criteria

14 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Psychiatry, First Affiliated Hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation

Repetitive Transcranial magnetic stimulation and sham transcranial alternating current stimulation

Sham repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation

Arm Description

rTMS and tACS have a profound impact on cognitive impairment.,The damaged neural circuit of DLPFC-DACC may lead to impaired cognitive function in bipolar disorder.We used DTI imaging technology to calculate the stimulus site.Using high-frequency rTMS and high-precision tACS stimulation,thus affect the nerve ring pathway , thereby rapidly, effectively and safely improving cognitive impairment with bipolar disorder in remission.the subjects were subjected to rTMS for 20 minutes per day with the stimulation intensity of 10Hz and 100% of the motion threshold(MT),stimulation time of each sequence was 5 seconds, stimulation interval was 15 seconds, 3000 pulses per day for 15 days, and the total number of pulses was 45000. tACS has 5 high-precision targets, the total current is 2mA, and the stimulation frequency is 40hz. Under true stimulation, the current fade in and out time is 10 seconds, and the stimulation time is 30 minutes.

the subjects were subjected to rTMS for 20 minutes per day with the stimulation intensity of 10Hz and 100% of the motion threshold(MT),stimulation time of each sequence was 5 seconds, stimulation interval was 15 seconds, 3000 pulses per day for 15 days, and the total number of pulses was 45000. tACS has 5 high-precision targets, the total current is 2mA, and the stimulation frequency is 40hz. Under sham stimulation, the current fade in and out time is 10 seconds, the other 29 minutes and 40 seconds, no real current passes through.

The stimulus intensity was 20% of MT in the ShamComparator arm, and the remaining parameters were the same as the Active Comparator arm. tACS has 5 high-precision targets, the total current is 2mA, and the stimulation frequency is 40hz. Under true stimulation, the current fade in and out time is 10 seconds, and the stimulation time is 30 minutes.

Outcomes

Primary Outcome Measures

thinc-it
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

Secondary Outcome Measures

Full Information

First Posted
July 20, 2023
Last Updated
July 20, 2023
Sponsor
First Affiliated Hospital of Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05964777
Brief Title
rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder
Official Title
Efficacy and Safety of rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder: a Randomized, Double-blind, Sham Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
March 3, 2024 (Anticipated)
Study Completion Date
April 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder in Remission
Keywords
repetitive transcranial magnetic stimulation，Transcranial alternating current stimulation，diffusion tensor imaging，bipolar disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation
Arm Type
Active Comparator
Arm Description
rTMS and tACS have a profound impact on cognitive impairment.,The damaged neural circuit of DLPFC-DACC may lead to impaired cognitive function in bipolar disorder.We used DTI imaging technology to calculate the stimulus site.Using high-frequency rTMS and high-precision tACS stimulation,thus affect the nerve ring pathway , thereby rapidly, effectively and safely improving cognitive impairment with bipolar disorder in remission.the subjects were subjected to rTMS for 20 minutes per day with the stimulation intensity of 10Hz and 100% of the motion threshold(MT),stimulation time of each sequence was 5 seconds, stimulation interval was 15 seconds, 3000 pulses per day for 15 days, and the total number of pulses was 45000. tACS has 5 high-precision targets, the total current is 2mA, and the stimulation frequency is 40hz. Under true stimulation, the current fade in and out time is 10 seconds, and the stimulation time is 30 minutes.
Arm Title
Repetitive Transcranial magnetic stimulation and sham transcranial alternating current stimulation
Arm Type
Placebo Comparator
Arm Description
the subjects were subjected to rTMS for 20 minutes per day with the stimulation intensity of 10Hz and 100% of the motion threshold(MT),stimulation time of each sequence was 5 seconds, stimulation interval was 15 seconds, 3000 pulses per day for 15 days, and the total number of pulses was 45000. tACS has 5 high-precision targets, the total current is 2mA, and the stimulation frequency is 40hz. Under sham stimulation, the current fade in and out time is 10 seconds, the other 29 minutes and 40 seconds, no real current passes through.
Arm Title
Sham repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation
Arm Type
Placebo Comparator
Arm Description
The stimulus intensity was 20% of MT in the ShamComparator arm, and the remaining parameters were the same as the Active Comparator arm. tACS has 5 high-precision targets, the total current is 2mA, and the stimulation frequency is 40hz. Under true stimulation, the current fade in and out time is 10 seconds, and the stimulation time is 30 minutes.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation
Intervention Description
with the rapid development of neuroregulatory technology, rTMS and tACS have a profound impact on cognitive impairment. The damaged neural circuit of DLPFC-DACC may lead to impaired cognitive function in bipolar disorder.We used DTI imaging technology to calculate the DLPFC cortical region corresponding to the strongest point of dlpfc and DACC fiber connection as the stimulus site.Using high-frequency rTMS and high-precision tACS stimulation,thus affect the nerve ring pathway , thereby rapidly, effectively and safely improving cognitive impairment with bipolar disorder in remission.
Primary Outcome Measure Information:
Title
thinc-it
Description
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
Time Frame
0,3week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ShaoHua Hu, MD
Phone
13357169115
Ext
86
Email
dorhushaohua@zju.deu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaomei Zhang
Phone
13757275095
Ext
86
Email
zxm11982012@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ShaoHua Hu, MD
Organizational Affiliation
Zhejiang University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
China Zhejiang
Organizational Affiliation
The First Affiliated Hospital of Zhejiang University [Recruiting] Hangzhou, Zhejiang, China, 310000 Contact: ShaoHua Hu, MD 13957162903 dorhushaoh
Official's Role
Study Director
Facility Information:
Facility Name
Department of Psychiatry, First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hu ShaoHua, MD
Phone
13957162903
Email
dorhushaohua@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiaomei Zhang
Phone
zxm11982012@sina.com
Email
zxm11982012@sina.com

12. IPD Sharing Statement

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rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder

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