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New Techniques for Diagnosis and Treatment of Cognitive Impairment in Affective Disorder

Primary Purpose

Affective Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Transcranial direct 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 Affective Disorder

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 16-65 years old, regardless of gender;
  2. Meet DSM-V diagnostic criteria for depression or bipolar disorder;
  3. Duration of stable period ≥ 3 months;
  4. Young Mania Rating Scale (YMRS) ≤ 6 points;
  5. Hamilton Depression Rating Scale 17 - item (HDRS-17) score ≤ 7;
  6. The score of cognitive defects questionnaire (PDQ) ≥ 17;
  7. Han nationality, right-handed;
  8. 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.

Sites / Locations

  • The First Affiliated Hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Transcranial magnetic stimulation

Transcranial direct-current stimulation

Arm Description

Outcomes

Primary Outcome Measures

Wechsler Memory Scale
The Wechsler Memory Scale score was used to evaluate the degree of cognitive function, and the lower the score, the more severe the cognitive function impairment. The scoring threshold is 70 points. A lower score means more severe cognitive impairment.

Secondary Outcome Measures

Full Information

First Posted
May 26, 2022
Last Updated
March 9, 2023
Sponsor
First Affiliated Hospital of Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05596461
Brief Title
New Techniques for Diagnosis and Treatment of Cognitive Impairment in Affective Disorder
Official Title
Research on New Techniques for Diagnosis and Treatment of Neuropsychiatric Diseases - Research on New Techniques for Diagnosis and Treatment of Affective Disorders and Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
October 1, 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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to explore the pathological mechanism of cognitive impairment in patients with affective disorder based on brain gut axis research, preliminarily verify the clinical efficacy of new neural regulation technology on cognitive impairment, and establish an evaluation model to predict the efficacy of physical therapy for affective disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Affective Disorder

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Transcranial magnetic stimulation
Arm Type
Experimental
Arm Title
Transcranial direct-current stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Intervention Description
Setting up a new target for rTMS. In the past research, the common target of rTMS in the treatment of cognitive impairment of affective disorder was left Dorsolateral prefrontal CORTEX (DLPFC) . The left lateral DLPFC and the primary visual Cortex (V1) both play important roles in cognitive process. The regions with the strongest functional connection between V1 and DLPFC were selected as the stimulation targets.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
Targeted multi-channel tDCS based on individualized simulation scale can be combined with individualized simulation modeling optimization, and based on individual MRI information, through quantitative evaluation and intelligent algorithms to achieve stimulation parameter optimization, reduce the stimulation dose to non-target target areas, and improve target brain stimulation The treatment targeting and aggregation of the area can realize personalized and precise treatment.
Primary Outcome Measure Information:
Title
Wechsler Memory Scale
Description
The Wechsler Memory Scale score was used to evaluate the degree of cognitive function, and the lower the score, the more severe the cognitive function impairment. The scoring threshold is 70 points. A lower score means more severe cognitive impairment.
Time Frame
0-8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 16-65 years old, regardless of gender; Meet DSM-V diagnostic criteria for depression or bipolar disorder; Duration of stable period ≥ 3 months; Young Mania Rating Scale (YMRS) ≤ 6 points; Hamilton Depression Rating Scale 17 - item (HDRS-17) score ≤ 7; The score of cognitive defects questionnaire (PDQ) ≥ 17; Han nationality, right-handed; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hu ShaoHua, M.D
Phone
13357169115
Ext
+86
Email
dorhushaohua@zju.deu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wang DanDan
Phone
18867132330
Ext
+86
Email
851176155@qq.com
Facility Information:
Facility Name
The 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
Phone
13957162903
Email
dorhushaohua@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

New Techniques for Diagnosis and Treatment of Cognitive Impairment in Affective Disorder

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