CClinicalTrials.gg
Status unknownNCT05596461Updated Mar 10, 2023

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

An interventional study of Transcranial magnetic stimulation and Transcranial direct current stimulation in Affective Disorder, sponsored by First Affiliated Hospital of Zhejiang University. Status unknown at 1 site in China. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-10.

Sponsored by First Affiliated Hospital of Zhejiang University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2022, registered May 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Affective Disorder
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's planned enrollment of 90 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 255 studies on the registry; 139 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Transcranial magnetic stimulation

    Device: Transcranial magnetic stimulation

  • Experimental
    Transcranial direct-current stimulation

    Device: Transcranial direct current stimulation

Interventions

  • DeviceTranscranial magnetic stimulation

    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.

  • DeviceTranscranial direct current stimulation

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0-8 weeks

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Zhejiang University
    Hangzhou, Zhejiang 310000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05596461
Lead sponsor
First Affiliated Hospital of Zhejiang University
Responsible party
Hu ShaoHua (Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University, First Affiliated Hospital of Zhejiang University) — Principal investigator
First posted
Oct 27, 2022
Start date
Jan 1, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
Mar 10, 2023

Study contacts

Hu ShaoHua, M.D
Contact
dorhushaohua@zju.deu.cn
13357169115 ext. +86
Wang DanDan
Contact
851176155@qq.com
18867132330 ext. +86

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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