- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05913960
Accelerated Intermittent Theta-Burst Stimulation Ameliorate Major Depressive Disorder by Regulating CAMKII Pathway
the Mechanism of Accelerated Intermittent Theta Burst Stimulation for Rapid Treatment of Major Depressive Disorder Based on the Prefrontal Excitation-inhibition Balance Regulated by CAMKII Pathway
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Recruiting
- The First Affiliated Hospital,Zhejiang University School of Medicine
-
Contact:
- Manli Huang, Dr
- Phone Number: +86 13957162975
- Email: huangmanli@zju.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Sign a written informed consent to participate in the trial and receive treatment;
- Major depressive disorder diagnosis;
- Hamilton depression scale (HAMD - 24) 24 total score 20 points or more;
- First episode or recurrence of depression patients, not taking psychiatric drugs;
- The han nationality, right-handed;
- Junior high school or above;
Exclusion Criteria:
- Other organic mental disorders and mental retardation and other severe mental disorders;
- Infection, trauma, and autoimmune diseases or other possible interference test evaluation of disease;
- Alcohol and drug dependence or is being treated for a hormone drugs patients;
- Craniocerebral injury;
- Seizure or a family history of epilepsy;
- Pregnancy and lactation women;
- All landowners had a metal and MRI contraindications or MRI examination revealed abnormal brain structure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Placebo stimulation
The sham group of MDD will receive sham rTMS stimulation.
|
The parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
|
Active Comparator: accelerated intermittent theta burst stimulation
Stimulation site: According to the localization of neural orientation navigation system, magnetic resonance data was read in Brainsight software, and three-dimensional brain reconstruction was carried out.
The stimulation target was located in the coordinates of Montreal Neurological Institute (MNI), which was located in the left dorsolateral prefrontal cortex BA46(-44, 40, 29).The treatment intensity was 100% exercise threshold, and a TBS stimulus series was stimulated for 2 seconds, including 10 times of 3 intra plexus stimuli of 50Hz and 5Hz intraplexus stimuli, 10s of interval, repeated 60 times, that is, a total of 1800 pulses per treatment, 10 times a day, 50 minutes interval, a total of 18000 pulses per day, continuous for 5 days.
|
Participants in the active stimulation group will receive the accelerated intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the neuronavigation system. Stimulation intensity will be standardized at 90% of RMT. Stimulation will be delivered to the L-DLPFC using an NTK-TMS-II100 TMS device,is compatible with the Brainsight TMS navigation system. |
Active Comparator: high frequency stimulation
Stimulation site: According to the localization of neural orientation navigation system, magnetic resonance data was read in Brainsight software, and three-dimensional brain reconstruction was carried out.
The stimulation target was located in the coordinates of Montreal Neurological Institute (MNI), which was located in the left dorsolateral prefrontal cortex BA46(-44, 40, 29).Treatment intensity was 100% exercise threshold, continuous 10Hz stimulation, repeated 75 times, that is, 3000 pulses per treatment, 6 times a day, 50 minutes interval, a total of 18000 pulses per day, continuous stimulation for 5 days.
|
Participants in the active stimulation group will receive the high frequnency stimulation to left DLPFC. The L-DLPFC will be targeted utilizing the neuronavigation system. Stimulation intensity will be standardized at 90% of RMT. Stimulation will be delivered to the L-DLPFC using an NTK-TMS-II100 TMS device,is compatible with the Brainsight TMS navigation system. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamilton depression scale-24
Time Frame: baseline
|
Assessement of depressive status,a score of more than 35 May indicate severe depression; More than 20 points, may be mild or moderate depression; A score of less than 8 indicates no symptoms of depression
|
baseline
|
Hamilton depression scale-24
Time Frame: 5days
|
Assessement of depressive status,a score of more than 35 May indicate severe depression; More than 20 points, may be mild or moderate depression; A score of less than 8 indicates no symptoms of depression
|
5days
|
Hamilton depression scale-24
Time Frame: 4 weeks
|
Assessement of depressive status,a score of more than 35 May indicate severe depression; More than 20 points, may be mild or moderate depression; A score of less than 8 indicates no symptoms of depression
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the score of THINC-it.
Time Frame: Baseline
|
THINC-it is a computerized cognitive screening tool that is designed to assess cognitive function in adults.
THINC-it stands for "THINking Clearly," and it includes a series of brief tests that evaluate several cognitive domains, including attention, working memory, executive function, and processing speed.
The tool is administered on a tablet or computer, and it takes approximately 20 minutes to complete.
|
Baseline
|
Change in the score of THINC-it.
Time Frame: 5 days
|
THINC-it is a computerized cognitive screening tool that is designed to assess cognitive function in adults.
THINC-it stands for "THINking Clearly," and it includes a series of brief tests that evaluate several cognitive domains, including attention, working memory, executive function, and processing speed.
The tool is administered on a tablet or computer, and it takes approximately 20 minutes to complete.
|
5 days
|
Change in the score of THINC-it.
Time Frame: 4 weeks
|
THINC-it is a computerized cognitive screening tool that is designed to assess cognitive function in adults.
THINC-it stands for "THINking Clearly," and it includes a series of brief tests that evaluate several cognitive domains, including attention, working memory, executive function, and processing speed.
The tool is administered on a tablet or computer, and it takes approximately 20 minutes to complete.
|
4 weeks
|
Change in neuroimaging using functional magnetic resonance
Time Frame: Baseline
|
Scanning functional magnetic resonance.
Functional magnetic resonance imaging (fMRI) is a neuroimaging technique that is used to measure changes in brain activity by detecting changes in blood flow.
In the context of major depression, fMRI has been used to study changes in brain function that may be associated with the condition.
Research using fMRI in major depression has shown that there are alterations in the activity of certain brain regions in people with the condition.
Specifically, fMRI studies have identified changes in the activity of the prefrontal cortex, the amygdala, and the hippocampus in people with major depression.
Overall, fMRI has provided valuable insights into the neural mechanisms underlying major depression, and may help to inform the development of new treatments for the condition.
|
Baseline
|
Change in neuroimaging using functional magnetic resonance
Time Frame: 5 days
|
Scanning functional magnetic resonance.
Functional magnetic resonance imaging (fMRI) is a neuroimaging technique that is used to measure changes in brain activity by detecting changes in blood flow.
In the context of major depression, fMRI has been used to study changes in brain function that may be associated with the condition.
Research using fMRI in major depression has shown that there are alterations in the activity of certain brain regions in people with the condition.
Specifically, fMRI studies have identified changes in the activity of the prefrontal cortex, the amygdala, and the hippocampus in people with major depression.
Overall, fMRI has provided valuable insights into the neural mechanisms underlying major depression, and may help to inform the development of new treatments for the condition.
|
5 days
|
Change of blood factor levels
Time Frame: baseline
|
Factors carried by peripheral blood and exosomes(Calcium/calmodulin dependent kinase II, cyclic-AMP dependent protein kinase A,protein kinase C and so on ).
|
baseline
|
Change of blood factor levels
Time Frame: 5 days
|
Factors carried by peripheral blood and exosomes(Calcium/calmodulin dependent kinase II, cyclic-AMP dependent protein kinase A,protein kinase C and so on ).
|
5 days
|
Change of blood factor levels
Time Frame: 4 weeks
|
Factors carried by peripheral blood and exosomes(Calcium/calmodulin dependent kinase II, cyclic-AMP dependent protein kinase A,protein kinase C and so on ).
|
4 weeks
|
Change in electroencephalogram
Time Frame: baseline
|
Electroencephalogram is collected from 64 electrodes.
EEG can be used to identify patterns of brain activity that are associated with the condition and to inform treatment decisions.
EEG can be a useful tool for identifying patterns of brain activity that are associated with MDD and for guiding treatment decisions.
Neurofeedback and TMS are two approaches that have shown promise in the treatment of MDD.
several parameters are analyzed to identify patterns of brain activity that may be associated with the condition.
These parameters include: Alpha power, Beta power, Theta power, Delta power, Coherence, and more.
|
baseline
|
Change in electroencephalogram
Time Frame: 5 days
|
Electroencephalogram is collected from 64 electrodes.
EEG can be used to identify patterns of brain activity that are associated with the condition and to inform treatment decisions.
EEG can be a useful tool for identifying patterns of brain activity that are associated with MDD and for guiding treatment decisions.
Neurofeedback and TMS are two approaches that have shown promise in the treatment of MDD.
several parameters are analyzed to identify patterns of brain activity that may be associated with the condition.
These parameters include: Alpha power, Beta power, Theta power, Delta power, Coherence, and more.
|
5 days
|
Hamilton anxiety scale
Time Frame: baseline
|
Assessement of anxious status.A total score of more than 29 May indicate severe anxiety; Over 21 points, there may be significant anxiety; More than 14 points, may have moderate anxiety; More than 7 points, may have mild anxiety; If the score is less than 7, there are no symptoms of anxiety
|
baseline
|
Hamilton anxiety scale
Time Frame: 5 days
|
Assessement of anxious status.A total score of more than 29 May indicate severe anxiety; Over 21 points, there may be significant anxiety; More than 14 points, may have moderate anxiety; More than 7 points, may have mild anxiety; If the score is less than 7, there are no symptoms of anxiety
|
5 days
|
Hamilton anxiety scale
Time Frame: 4 weeks
|
Assessement of anxious status.A total score of more than 29 May indicate severe anxiety; Over 21 points, there may be significant anxiety; More than 14 points, may have moderate anxiety; More than 7 points, may have mild anxiety; If the score is less than 7, there are no symptoms of anxiety
|
4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IITA20230315
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depressive Disorder
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on sham stimulation
-
National Cheng-Kung University HospitalRecruiting
-
Georgia Institute of TechnologyEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsNot yet recruiting
-
Sheba Medical CenterSuspended
-
Tianjin Anding HospitalChinese Academy of SciencesEnrolling by invitationSchizophrenia Negative TypeChina
-
Beijing Tiantan HospitalPeking Union Medical College Hospital; China-Japan Friendship Hospital; The First...Unknown
-
Mary Phillips, MD MD (Cantab)National Institute of Mental Health (NIMH)RecruitingBipolar DisorderUnited States
-
Christian BaumannETH ZurichRecruitingParkinson Disease | Mild Cognitive Impairment | Huntington DiseaseSwitzerland
-
Dr. med. Carlo CeredaUniversity Hospital Inselspital, Berne; CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE... and other collaboratorsUnknownIschemic Stroke | First Ever Clinical Stroke | Subacute Phase | Persistent Hemiparesis of Upper ExtremitySwitzerland
-
University of PittsburghCompleted
-
University of ManitobaRecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Paraplegia, Spinal | Paraplegia, IncompleteCanada