Impaired InsightNCT06831877
Study on Deep Transcranial Magnetic Stimulation for Enhancing Insight
A study testing active-dTMS in people with Impaired Insight, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Impaired insight is a key factor in the conversion of high-risk individuals to schizophrenia, but there is a lack of targeted interventions. We found that an electroencephalogram (EEG) signal, error-related negativity (ERN), was closely related to impaired insight. Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Impaired Insight
- What is being tested?
- active-dTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meet the criteria of clinical high risk for psychosis or meet the DSM-V diagnostic criteria for schizophrenia;
- Meeting the following definition of impaired insight: below a specific threshold in at least one dimension of the Scale to Assess Unawareness of Mental Disorder (SAI). Specifically, a score of less than 2 in the "awareness of the need for treatment" dimension, less than 3 in the "recognition of illness" dimension, or less than 2 in the "attribution of psychotic symptoms" dimension qualifies an individual as having impaired insight;
- Having completed at least six years of primary education;
- Being able to give informed consent, oral or written. Patients under 18 years old give oral consent and their next of kin or legal guardians give written consent.
Who cannot join
- Participating in any other clinical intervention research;
- Meeting the diagnostic criteria of psychotic disorders (including affective disorders);
- Threshold symptoms are induced by other mental disorders or psychoactive substances;
- Undergoing anti-psychotic medication for more than 2 weeks;
- Being diagnosed as organic brain diseases, or severe somatic diseases;
- Had Experienced traumatic brain injury, and got scores of 7;
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- Dementia, or mental retardation (IQ<70);
- Being a condition of scalp infection;
- A pacemaker or other metal implants in the body, pregnancy, or claustrophobia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Weimin Yang, 18017311052, kjksmhc@yeah.net
About this study
Official title: Targeted Intervention Study of Deep Transcranial Magnetic Stimulation for Impaired Insight in Patients with High-Risk and First-Episode Psychosis
Impaired insight is a key factor in the conversion of high-risk individuals to schizophrenia, but there is a lack of targeted interventions. We found that an electroencephalogram (EEG) signal, error-related negativity (ERN), was closely related to impaired insight. The more pronounced the ERN attenuation in patients with high-risk and first-episode psychosis, the more severe the impairement of clinical insight. ERN is a negative potential that appears at the frontal and central scalp electrode locations within 100 ms after an erroneous behavioral response, reflecting the activity of the brain's error-monitoring system. Research has shown that the brain region underlying ERN is partly located in the anterior cingulate cortex (ACC). Other research has reported that the activity extending from the ACC to the medial prefrontal cortex (mPFC) is associated with impaired insight in patients with various disorders. Therefore, this project targets mPFC/ACC and uses deep transcranial magnetic stimulation (dTMS) for targeted modulation, with an exploratory observation of changes in patients' insight before and after neurostimulation.
Read the detailed description
This study will be carried out at a single center, the Shanghai Mental Health Center (SMHC).
- Modulating ACC Functional Activity Using dTMS to Observe Changes in Insight Among FES and CHR Before and After Intervention This study will employ a randomized, double-blind, sham-controlled experimental design. dTMS intervention will be administered for 10 consecutive days, with two sessions per day, ensuring at least a 3-hour interval between sessions. A total of 36 FES participants and 68 CHR participants with impaired insight will be recruited. Participants will be randomly assigned to either the active-dTMS group or the sham-dTMS group to compare changes in insight between the two conditions. This study will conduct clinical assessments and laboratory testing before and immediately after the intervention. Additionally, clinical assessments will be performed at one month and three months post-intervention to analyze the sustained effects of dTMS in modulating ACC functional activity to improve insight.
- Follow-Up of CHR Participants to Analyze the Predictive Role of Insight and ACC Functional Activity on CHR Outcomes A prospective cohort design will be used to compare the transition outcomes among three CHR groups: the active-dTMS group, the sham-dTMS group, and an observational control group. The primary focus is to examine the probability of conversion to schizophrenia at a one-year follow-up and to analyze the extent to which insight and ACC functional activity predict CHR outcomes. 34 CHR participants with intact insight (observational control group) will be recruited for baseline assessments and laboratory testing, followed by a one-year follow-up. By comparing baseline assessments, laboratory indicators, and clinical outcomes between the observational control group and the CHR intervention groups (active-dTMS and sham-dTMS), this study aims to determine whether improvement in insight in the active-dTMS group leads to prognostic outcomes comparable to those of the observational control group. Specifically, it will assess whether the risk of conversion to schizophrenia in the active-dTMS group becomes statistically indistinguishable from that of the observational control group.
- Conditions
- Impaired Insight
- Being tested
- active-dTMS, sham-dTMS
- Keywords
- Insight, Self monitoring, Anterior cingulate cortex, Medial prefrontal cortex, Deep transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active-dTMSDevice
The dTMS using H-coil with 5Hz stimulate ACC. The sessions of dTMS will be conducted twice daily for 5 consecutive days, and twice sessions of a day will be separated by 3 hours at least.
sham-dTMSDevice
The sham-dTMS has the same appearance with the real stimulation coil, which can not generate magnetic field. A sound generator is built in the coil beat to simulate the sound of the real stimulation.
| Study group | Role | What they receive |
|---|---|---|
| active-CHR | Active comparator | Individuals with clinical high risk for psychosis (CHR) will be intervened with dTMS. Receives: Device: active-dTMS |
| sham-CHR | Sham comparator | Individuals with CHR, as a control group, will receive sham stimulation. Receives: Device: sham-dTMS |
| NoI-CHR | No intervention | For the observation group of CHR, baseline assessments will be conducted, and follow-up outcomes will be observed one year later. Clinical outcomes will be compared with those of the CHR intervention group. |
| active-FEP | Active comparator | Patients with first-episode psychosis (FEP) will be intervened with dTMS. Receives: Device: active-dTMS |
| sham-FEP | Sham comparator | FEP patients , as a control group, will receive sham stimulation. Receives: Device: sham-dTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Insight
Clinical insight will be assessed using the SAI (Schedule for Assessment of Insight). The SAI is a semi-structured interview tool consisting of seven items, with a total score of 14. It evaluates three areas: illness recognition (scoring 0-6), relabeling of symptoms (scoring 0-4), and treatment compliance (scoring 0-4). Patients are considered to have impaired insight if they score less than 3 on illness recognition, less than 2 on relabeling of symptoms, and less than 2 on treatment compliance.
Measured: Baseline and immediately after the intervention
Secondary outcomes (5)
Error-related negativity
The error-related negativity (ERN) is observed over frontocentral sites within 100 ms following an error response in behavioral tasks and a reduced ERN indicates reduced error monitoring. EEG epochs were marked with artifacts and excluded from the following ERN analysis if on any electrode, (i) the maximal peak-to-peak amplitude exceeded 100 μV within any moving window (width: 200 ms; step: 50 ms) or (ii) the absolute amplitude exceeded 100 μV at any time point. The calculation for the ERN was based on no fewer than five available epochs with erroneous responses.
Measured: Baseline and immediately after the intervention
Resting-state functional activity of the anterior cingulate cortex (ACC) and its functional connectivity with the whole brain
Imaging data will be collected on a 3 Tesla Siemens Prisma scanner with a 64-channel Siemens head coil, including structural phase and resting stage detection, which will be used to analyze the functional activity.
Measured: Baseline and immediately after the intervention
Psychopathological symptoms
This study will also observe the psychopathological symptoms, including positive, negative and general symptoms, using PANSS.The reductive ratio of PANSS points will be calculated after dTMS treatment.
Measured: Baseline and immediately after the intervention
Reality monitoring ability
Reality monitoring ability refers to distinguish internally self-generated information from externally-derived information. The test will be carried out by the experimental paradigm of reality monitoring ability.The stimulus materials are easy to be accepted and understood by patients with mental illness.The material consisted of 48 pairs of familiar pictures and was divided into two tests, each consisting of a learning and a testing phase. In the learning phase, 24 pictures will be presented with different combinations of conditions (four combinations of "perceptive/imaginative × left/right" conditions). In the testing phase, one object will be presented and the participants will be asked to decide whether the other paired object is perceptive or imaginative, or whether the image is positioned on the left or right side of the screen.
Measured: Baseline and immediately after the intervention
Convertion rate of transition into psychosis
This study will use SIPS to identify individuals with CHR and assess the participants' clinical outcomes, including transition into psychosis, symptomatic, remission, and other disorders
Measured: 1-2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired InsightStudies of the same condition, open and under way.
- 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
- Participants will be randomly assigned to different montage of stimulation, including deep transcranial magnetic stimulation (active-dTMS) and sham stimulation (sham-dTMS).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jijun Wang, Study director, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831877
- Sponsor's protocol ID
- dTMS and Insight
- Status last verified
- Dec 2024
- First submitted
- 12 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Intervention Study of Deep Transcranial Magnetic Stimulation for Impaired Insight in Patients with High-Risk and First-Episode Psychosis
- ClinicalTrials.gov ID
- NCT06831877
- Acronym / sponsor ID
- dTMS and Insight
- Conditions
- Impaired Insight
- Keywords
- Insight, Self monitoring, Anterior cingulate cortex, Medial prefrontal cortex, Deep transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 18 Feb 2025 (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.
Impaired insight is a key factor in the conversion of high-risk individuals to schizophrenia, but there is a lack of targeted interventions. We found that an electroencephalogram (EEG) signal, error-related negativity (ERN), was closely related to impaired insight. The more pronounced the ERN attenuation in patients with high-risk and first-episode psychosis, the more severe the impairement of clinical insight. ERN is a negative potential that appears at the frontal and central scalp electrode locations within 100 ms after an erroneous behavioral response, reflecting the activity of the brain's error-monitoring system. Research has shown that the brain region underlying ERN is partly located in the anterior cingulate cortex (ACC). Other research has reported that the activity extending from the ACC to the medial prefrontal cortex (mPFC) is associated with impaired insight in patients with various disorders. Therefore, this project targets mPFC/ACC and uses deep transcranial magnetic stimulation (dTMS) for targeted modulation, with an exploratory observation of changes in patients' insight before and after neurostimulation.
Detailed description
This study will be carried out at a single center, the Shanghai Mental Health Center (SMHC).
- Modulating ACC Functional Activity Using dTMS to Observe Changes in Insight Among FES and CHR Before and After Intervention This study will employ a randomized, double-blind, sham-controlled experimental design. dTMS intervention will be administered for 10 consecutive days, with two sessions per day, ensuring at least a 3-hour interval between sessions. A total of 36 FES participants and 68 CHR participants with impaired insight will be recruited. Participants will be randomly assigned to either the active-dTMS group or the sham-dTMS group to compare changes in insight between the two conditions. This study will conduct clinical assessments and laboratory testing before and immediately after the intervention. Additionally, clinical assessments will be performed at one month and three months post-intervention to analyze the sustained effects of dTMS in modulating ACC functional activity to improve insight.
- Follow-Up of CHR Participants to Analyze the Predictive Role of Insight and ACC Functional Activity on CHR Outcomes A prospective cohort design will be used to compare the transition outcomes among three CHR groups: the active-dTMS group, the sham-dTMS group, and an observational control group. The primary focus is to examine the probability of conversion to schizophrenia at a one-year follow-up and to analyze the extent to which insight and ACC functional activity predict CHR outcomes. 34 CHR participants with intact insight (observational control group) will be recruited for baseline assessments and laboratory testing, followed by a one-year follow-up. By comparing baseline assessments, laboratory indicators, and clinical outcomes between the observational control group and the CHR intervention groups (active-dTMS and sham-dTMS), this study aims to determine whether improvement in insight in the active-dTMS group leads to prognostic outcomes comparable to those of the observational control group. Specifically, it will assess whether the risk of conversion to schizophrenia in the active-dTMS group becomes statistically indistinguishable from that of the observational control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Participants will be randomly assigned to different montage of stimulation, including deep transcranial magnetic stimulation (active-dTMS) and sham stimulation (sham-dTMS).
| Arm | Type | Receives |
|---|---|---|
| active-CHR | Active comparator | Device: active-dTMSIndividuals with clinical high risk for psychosis (CHR) will be intervened with dTMS. |
| sham-CHR | Sham comparator | Device: sham-dTMSIndividuals with CHR, as a control group, will receive sham stimulation. |
| NoI-CHR | No intervention | –For the observation group of CHR, baseline assessments will be conducted, and follow-up outcomes will be observed one year later. Clinical outcomes will be compared with those of the CHR intervention group. |
| active-FEP | Active comparator | Device: active-dTMSPatients with first-episode psychosis (FEP) will be intervened with dTMS. |
| sham-FEP | Sham comparator | Device: sham-dTMSFEP patients , as a control group, will receive sham stimulation. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Meet the criteria of clinical high risk for psychosis or meet the DSM-V diagnostic criteria for schizophrenia;
- Meeting the following definition of impaired insight: below a specific threshold in at least one dimension of the Scale to Assess Unawareness of Mental Disorder (SAI). Specifically, a score of less than 2 in the "awareness of the need for treatment" dimension, less than 3 in the "recognition of illness" dimension, or less than 2 in the "attribution of psychotic symptoms" dimension qualifies an individual as having impaired insight;
- Having completed at least six years of primary education;
- Being able to give informed consent, oral or written. Patients under 18 years old give oral consent and their next of kin or legal guardians give written consent.
Key exclusion criteria (9 listed)
- Participating in any other clinical intervention research;
- Meeting the diagnostic criteria of psychotic disorders (including affective disorders);
- Threshold symptoms are induced by other mental disorders or psychoactive substances;
- Undergoing anti-psychotic medication for more than 2 weeks;
- Being diagnosed as organic brain diseases, or severe somatic diseases;
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 |
|---|---|---|
| active-dTMSThe dTMS using H-coil with 5Hz stimulate ACC. The sessions of dTMS will be conducted twice daily for 5 consecutive days, and twice sessions of a day will be separated by 3 hours at least. | Device | active-CHR, active-FEP |
| sham-dTMSThe sham-dTMS has the same appearance with the real stimulation coil, which can not generate magnetic field. A sound generator is built in the coil beat to simulate the sound of the real stimulation. | Device | sham-CHR, sham-FEP |
Primary outcome
Clinical Insight
Time frame: Baseline and immediately after the intervention
Clinical insight will be assessed using the SAI (Schedule for Assessment of Insight). The SAI is a semi-structured interview tool consisting of seven items, with a total score of 14. It evaluates three areas: illness recognition (scoring 0-6), relabeling of symptoms (scoring 0-4), and treatment compliance (scoring 0-4). Patients are considered to have impaired insight if they score less than 3 on illness recognition, less than 2 on relabeling of symptoms, and less than 2 on treatment compliance.
5 secondary outcomes
Error-related negativity
Time frame: Baseline and immediately after the intervention
Resting-state functional activity of the anterior cingulate cortex (ACC) and its functional connectivity with the whole brain
Time frame: Baseline and immediately after the intervention
Psychopathological symptoms
Time frame: Baseline and immediately after the intervention
Reality monitoring ability
Time frame: Baseline and immediately after the intervention
Convertion rate of transition into psychosis
Time frame: 1-2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- 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.
Jijun Wang study director
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active-dTMS in people with Impaired Insight, 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 18 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lihua Xu, Doctoral (15000092086, mas_xulihua2008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Insight (time frame: Baseline and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2025.