SchizophreniaNCT03608462
Modulation of Repetitive Transcranial Magnetic Stimulation on Hippocampal Neurogenesis and Functional Network in Patients With Schizophrenia
A study testing repetitive transcranial magnetic stimulation(DLPFC) and repetitive transcranial magnetic stimulation(LPC) in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Based on the hypothesis that high-frequency repetitive transcranial magnetic stimulation(rTMS) on the right dorsolateral prefrontal cortex(DLPFC) and left parietal cortex(LPC) could normalise cognitive abnormalities by promoting hippocampal neurogenesis and cortical-hippocampal function in patients with… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- repetitive transcranial magnetic stimulation(DLPFC) and repetitive transcranial magnetic stimulation(LPC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Dec 2021
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The Structured Interview for Prodromal Symptoms (SIPS) was employed.
- Meet the diagnostic criteria of Diagnostic and Statistical Manual Diploma in Social Medicine(DSM-V) schizophrenia or schizophreniform psychosis.
- 18-50years of age,right-handed,normal vision or corrected vision, Han nationality.
- Disease course less than 5 years.
- Written informed consent
- Observation group: First-episode, In addition to criteria1-3,5,antipsychotics naïve,or antipsychotics withdrawal for more than 3 months.
Show all 11Show fewer
- Intervention group:In addition to criteria 1-6,currently under medication and medically stable for at least 1 month(PANSS score fluctuation<10%);continue the original antipsychotics for at least 1 months after recruitment,with consent of the patients,their psychiatrists and family members.
- The Structured Interview for Prodromal Symptoms (SIPS) was employed
- Matched to the early schizophrenia group in terms of age,sex ratio,handedness,and estimated premorbid IQ
- normal vision or corrected vision, Han nationality
- Written informed consent
Who cannot join
- Current or past neurological illness,severe physical illness,substance abuse or addiction,alcohol dependence,mental retardation,pregnancy or lactation,extreme agitation, stupor, negative suicide,or those who can not cooperate.A history of MECT within 6 months,or those with contraindications to MRI,rTMS.Medically unstable for at least 1 month (PANSS score fluctuation>10%)
- Healthy controls:
- History of psychiatric disease in the subjects themselves or a family history of mental disorder in their first-degree relatives,neurological illness,severe physical illness,substance abuse or alcohol dependence,mental retardation.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Modulation of rTMS on Hippocampal Neurogenesis and Functional Network in Early Schizophrenia
Based on the hypothesis that high-frequency repetitive transcranial magnetic stimulation(rTMS) on the right dorsolateral prefrontal cortex(DLPFC) and left parietal cortex(LPC) could normalise cognitive abnormalities by promoting hippocampal neurogenesis and cortical-hippocampal function in patients with schizophrenia,this research plan to utilise multimodal functional magnetic imaging method(including structural MRI,resting-state functional magnetic resonance imaging and 1H-MRS) to investigate therapeutic efficacy of intermittent theta burst stimulation (iTBS) on cognitive impairment in SZ patients with memory defects,as well as to elucidate the correlation between treatment effects and hippocampal neuroplasticity.
Read the detailed description
This study includes 150 schizophrenia patients and 30 healthy controls.This study will investigate 1).abnormalities of hippocampal neurogenesis in patients with schizophrenia compared to healthy controls by using 1H-MRS technique 2a).potential modulation effects of repetitive transcranial magnetic stimulation(rTMS) on hippocampal neurogenesis and cortical-hippocampal function of patients with schizophrenia 2b).the optimal rTMS therapy pattern on promoting hippocampal neurogenesis and improving cortico-hippocampal function by comparing the outcome of stimulating two regions(right dorsolateral prefrontal cortex or left parietal cortex) respectively 3).the therapeutic efficacy of rTMS on cognitive impairments and other psychotic symptoms of patients with schizophrenia by adopting cognitive function and psychotic symptoms evaluation,as well as to explore the optimal rTMS treatment pattern on cognitive function by comparing the outcome of stimulating two regions(DLPFC or LPC) respectively 4)association between therapeutic efficacy of rTMS on cognitive deficits and rTMS modulation on hippocampal neurogenesis and its network function,in order to elucidate the underlying mechanism of therapeutic effects of rTMS on cognitive dysfunction in schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- repetitive transcranial magnetic stimulation(DLPFC), repetitive transcranial magnetic stimulation(LPC)
- Keywords
- first episode schizophrenia, rTMS, hippocampal neurogenesis, MRS, cognitive function
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation(DLPFC)Device
high frequency(20Hz) repetitive transcranial magnetic stimulation on dorsolateral prefrontal cortex(DLPFC) .Duration:10 days.
repetitive transcranial magnetic stimulation(LPC)Device
high frequency(20Hz) repetitive transcranial magnetic stimulation on left parietal cortex(LPC).Duration:10 days
| Study group | Role | What they receive |
|---|---|---|
| rTMS targeting the right DLPFC | Sham comparator | 60 patients will be randomly allocated into this group,half of them will receive iTBS on the right DLPFC,while the other half will receive sham stimulation. Receives: Device: repetitive transcranial magnetic stimulation(DLPFC) |
| rTMS targeting the left LPC | Sham comparator | 60 patients will be randomly allocated into this group,half of them will receive iTBS on left LPC,while the other half will receive sham stimulation. Receives: Device: repetitive transcranial magnetic stimulation(LPC) |
| Observation group | No intervention | To investigate the abnormalities of hippocampal neurogenesis in patients with early schizophrenia(n=30) compared to healthy controls(n=30) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in MATRICS Consensus Cognitive Battery
MATRICS Consensus Cognitive Battery
Measured: baseline,24 hours after the rTMS treatment,30 days
Change of hippocampal neurogenesis(from baseline)
Quantify neural stem cells in hippocampal by using H1-MRS
Measured: baseline,24 hours after the rTMS treatment
Change of cortical-hippocampal functional network(from baseline)
Resting-state fMRI data are acquired
Measured: baseline,24 hours after the rTMS treatment
Change from baseline in associative memory
associative memory
Measured: baseline,24 hours after the rTMS treatment,30 days
Secondary outcomes (3)
Change from baseline in Positive and Negative Syndrome Scale(PANSS)
Positive and Negative Syndrome Scale(PANSS)
Measured: baseline,24 hours after the rTMS treatment,30 days
Change from baseline in the Scale for the Assessment of Negative Symptoms(SANS)
Scale for the Assessment of Negative Symptoms
Measured: baseline,24 hours after the rTMS treatment,30 days
Change from baseline in UCSD Performance-based Skills Assessment-Brief(UPSA-B)
UCSD Performance-based Skills Assessment-Brief
Measured: baseline,24 hours after the rTMS treatment,30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Apr 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2021 (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 SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- Model description
- In this research,we combine a cross-sectional case control study and a randomized controlled study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608462
- Sponsor's protocol ID
- YG2017ZD13
- Status last verified
- Jan 2021
- First submitted
- 9 Jul 2018
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Xiang Q, Cen H, Zhai Z, Gao T, Lu C, Dong Y, Ye Y, Zhang C, Zhuo K, Wang Y, Liu D. Efficacy of Cortical-Hippocampal Target Intermittent Theta Burst Stimulation (iTBS) on Associative Memory of Schizophrenia: A Double-Blind, Randomized Sham-Controlled Trial. Neuropsychiatr Dis Treat. 2024 Oct 10;20:1941-1955. doi: 10.2147/NDT.S468219. eCollection 2024.
PubMed 39411184
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of rTMS on Hippocampal Neurogenesis and Functional Network in Early Schizophrenia
- ClinicalTrials.gov ID
- NCT03608462
- Acronym / sponsor ID
- YG2017ZD13
- Conditions
- Schizophrenia
- Keywords
- first episode schizophrenia, rTMS, hippocampal neurogenesis, MRS, cognitive function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 Aug 2018 (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.
Based on the hypothesis that high-frequency repetitive transcranial magnetic stimulation(rTMS) on the right dorsolateral prefrontal cortex(DLPFC) and left parietal cortex(LPC) could normalise cognitive abnormalities by promoting hippocampal neurogenesis and cortical-hippocampal function in patients with schizophrenia,this research plan to utilise multimodal functional magnetic imaging method(including structural MRI,resting-state functional magnetic resonance imaging and 1H-MRS) to investigate therapeutic efficacy of intermittent theta burst stimulation (iTBS) on cognitive impairment in SZ patients with memory defects,as well as to elucidate the correlation between treatment effects and hippocampal neuroplasticity.
Detailed description
This study includes 150 schizophrenia patients and 30 healthy controls.This study will investigate 1).abnormalities of hippocampal neurogenesis in patients with schizophrenia compared to healthy controls by using 1H-MRS technique 2a).potential modulation effects of repetitive transcranial magnetic stimulation(rTMS) on hippocampal neurogenesis and cortical-hippocampal function of patients with schizophrenia 2b).the optimal rTMS therapy pattern on promoting hippocampal neurogenesis and improving cortico-hippocampal function by comparing the outcome of stimulating two regions(right dorsolateral prefrontal cortex or left parietal cortex) respectively 3).the therapeutic efficacy of rTMS on cognitive impairments and other psychotic symptoms of patients with schizophrenia by adopting cognitive function and psychotic symptoms evaluation,as well as to explore the optimal rTMS treatment pattern on cognitive function by comparing the outcome of stimulating two regions(DLPFC or LPC) respectively 4)association between therapeutic efficacy of rTMS on cognitive deficits and rTMS modulation on hippocampal neurogenesis and its network function,in order to elucidate the underlying mechanism of therapeutic effects of rTMS on cognitive dysfunction in schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- In this research,we combine a cross-sectional case control study and a randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| rTMS targeting the right DLPFC | Sham comparator | Device: repetitive transcranial magnetic stimulation(DLPFC)60 patients will be randomly allocated into this group,half of them will receive iTBS on the right DLPFC,while the other half will receive sham stimulation. |
| rTMS targeting the left LPC | Sham comparator | Device: repetitive transcranial magnetic stimulation(LPC)60 patients will be randomly allocated into this group,half of them will receive iTBS on left LPC,while the other half will receive sham stimulation. |
| Observation group | No intervention | –To investigate the abnormalities of hippocampal neurogenesis in patients with early schizophrenia(n=30) compared to healthy controls(n=30) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- The Structured Interview for Prodromal Symptoms (SIPS) was employed.
- Meet the diagnostic criteria of Diagnostic and Statistical Manual Diploma in Social Medicine(DSM-V) schizophrenia or schizophreniform psychosis.
- 18-50years of age,right-handed,normal vision or corrected vision, Han nationality.
- Disease course less than 5 years.
- Written informed consent
Key exclusion criteria (3 listed)
- Current or past neurological illness,severe physical illness,substance abuse or addiction,alcohol dependence,mental retardation,pregnancy or lactation,extreme agitation, stupor, negative suicide,or those who can not cooperate.A history of MECT within 6 months,or those with contraindications to MRI,rTMS.Medically unstable for at least 1 month (PANSS score fluctuation>10%)
- Healthy controls:
- History of psychiatric disease in the subjects themselves or a family history of mental disorder in their first-degree relatives,neurological illness,severe physical illness,substance abuse or alcohol dependence,mental retardation.
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 |
|---|---|---|
| repetitive transcranial magnetic stimulation(DLPFC)high frequency(20Hz) repetitive transcranial magnetic stimulation on dorsolateral prefrontal cortex(DLPFC) .Duration:10 days. | Device | rTMS targeting the right DLPFC |
| repetitive transcranial magnetic stimulation(LPC)high frequency(20Hz) repetitive transcranial magnetic stimulation on left parietal cortex(LPC).Duration:10 days | Device | rTMS targeting the left LPC |
Primary outcome
Change from baseline in MATRICS Consensus Cognitive Battery
Time frame: baseline,24 hours after the rTMS treatment,30 days
MATRICS Consensus Cognitive Battery
Change of hippocampal neurogenesis(from baseline)
Time frame: baseline,24 hours after the rTMS treatment
Quantify neural stem cells in hippocampal by using H1-MRS
Change of cortical-hippocampal functional network(from baseline)
Time frame: baseline,24 hours after the rTMS treatment
Resting-state fMRI data are acquired
Change from baseline in associative memory
Time frame: baseline,24 hours after the rTMS treatment,30 days
associative memory
3 secondary outcomes
Change from baseline in Positive and Negative Syndrome Scale(PANSS)
Time frame: baseline,24 hours after the rTMS treatment,30 days
Change from baseline in the Scale for the Assessment of Negative Symptoms(SANS)
Time frame: baseline,24 hours after the rTMS treatment,30 days
Change from baseline in UCSD Performance-based Skills Assessment-Brief(UPSA-B)
Time frame: baseline,24 hours after the rTMS treatment,30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Derived from this study: PubMed 39411184Li X, Xiang Q, Cen H, Zhai Z, Gao T, Lu C, Dong Y, Ye Y, Zhang C, Zhuo K, Wang Y, Liu D. Efficacy of Cortical-Hippocampal Target Intermittent Theta Burst Stimulation (iTBS) on Associative Memory of Schizophrenia: A Double-Blind, Randomized Sham-Controlled Trial. Neuropsychiatr Dis Treat. 2024 Oct 10;20:1941-1955. doi: 10.2147/NDT.S468219. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation(DLPFC) and repetitive transcranial magnetic stimulation(LPC) in people with Schizophrenia, run by Shanghai Mental Health Center 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 11 inclusion and 3 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 27 Sep 2021. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in MATRICS Consensus Cognitive Battery (time frame: baseline,24 hours after the rTMS treatment,30 days). The study lists 4 primary outcomes in all. 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 NCT03608462, 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 27 Sep 2021.