Affective DisorderNCT05596461
New Techniques for Diagnosis and Treatment of Cognitive Impairment in Affective Disorder
A study testing Transcranial magnetic stimulation and Transcranial direct current stimulation in people with Affective Disorder, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Affective Disorder
- What is being tested?
- Transcranial magnetic stimulation and Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Hu ShaoHua, 13957162903, dorhushaohua@zju.edu.cn
About this study
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
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.
- Conditions
- Affective Disorder
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationDevice
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.
Transcranial direct current stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial magnetic stimulation | Experimental | Not described Receives: Device: Transcranial magnetic stimulation |
| Transcranial direct-current stimulation | Experimental | Not described Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Affective DisorderStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu ShaoHua, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596461
- Sponsor's protocol ID
- IIT20210036C-R1
- Status last verified
- Mar 2023
- First submitted
- 26 May 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou H, Wang M, Xu T, Zhang X, Zhao X, Tang L, Zhao P, Wang D, Lai J, Wang F, Zhang S, Hu S. Cognitive Remediation in Patients With Bipolar Disorder: A Randomized Trial by Sequential tDCS and Navigated rTMS Targeting the Primary Visual Cortex. CNS Neurosci Ther. 2024 Dec;30(12):e70179. doi: 10.1111/cns.70179.
PubMed 39703101
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05596461
- Acronym / sponsor ID
- IIT20210036C-R1
- Conditions
- Affective Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial magnetic stimulation | Experimental | Device: Transcranial magnetic stimulation |
| Transcranial direct-current stimulation | Experimental | Device: Transcranial direct current stimulation |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulationSetting 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. | Device | Transcranial magnetic stimulation |
| Transcranial direct current stimulationTargeted 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. | Device | Transcranial direct-current stimulation |
Primary outcome
Wechsler Memory Scale
Time frame: 0-8 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Derived from this study: PubMed 39703101Zhou H, Wang M, Xu T, Zhang X, Zhao X, Tang L, Zhao P, Wang D, Lai J, Wang F, Zhang S, Hu S. Cognitive Remediation in Patients With Bipolar Disorder: A Randomized Trial by Sequential tDCS and Navigated rTMS Targeting the Primary Visual Cortex. CNS Neurosci Ther. 2024 Dec;30(12):e70179. doi: 10.1111/cns.70179.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation and Transcranial direct current stimulation in people with Affective Disorder, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hu ShaoHua, M.D (13357169115 ext. +86, dorhushaohua@zju.deu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wechsler Memory Scale (time frame: 0-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05596461, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.