Impaired InsightNCT04513132
Targeted Intervention Study of DTMS on Impaired Insight in Early Psychosis
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 reflecting the function of self monitoring was a potential objective marker of 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
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2027
- 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 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 14~35 years old;
- 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;
- 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.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: A Study on Targeted Intervention for Insight in Patients with First Episode and Clinical High Risk of Schizophrenia Based on Theta Oscillation in Anterior Cingulate Cortex
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 reflecting the function of self monitoring was a potential objective marker of impaired insight. And further functional magnetic resonance imaging (fMRI) analysis showed that the functional connectivity between anterior cingulate gyrus (ACC) and medial temporal gyrus (MTG) was related to insight. Studies have shown that ACC theta oscillation is the key to self monitoring, and theta-alpha phase synchronization between frontotemporal is closely related to cognition. Therefore, this project hypothesized that targeted regulation of ACC theta oscillations could promote theta-alpha phase synchronization and functional connectivity between ACC and MTG, thereby improving patients' insight. The first-episode and high-risk subjects were recruited to detect the theta oscillation of ACC, theta-Alpha phase synchronization and functional connectivity between ACC and MTG using EEG-fMRI. Deep transcranial magnetic stimulation was introduced to regulate ACC theta oscillations. The high-risk subjects were followed up for two years. It was estimated that the theta-alpha phase synchronization of ACC-MTG and insight in the active-dTMS group were significantly improved. And the outcome of the high-risk subjects is better. The project develops neuroregulatory techniques for impaired insight of schizophrenia and is expected to provide a solution for this clinical pain point.
Read the detailed description
The study will conduct randomized and controlled experimental design, including deep transcranial magnetic stimulation (dTMS) and sham stimulation (SH-dTMS). Each included participant will be given informed consent and then randomly assigned to different montage of stimulation. Participants are blind to the dTMS montage. Researchers in this study will include clinical evaluators, laboratory inspectors, dTMS operators, and statistical analysts. Before unblinding, each group of researchers will have no access to the information collected by the other groups. For example, except the dTMS operators, no one knows which stimulus montage any of the participants receive. 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. Clinical assessments and laboratory tests will be administered at baseline and at the end of the last session. After the post-intervention tests, first stage unblinding will be conducted. At this moment, dTMS operators will provide the groups of A and B, but no corresponding montage, to the statistical analysts. After analyzing the differences between the two groups, second stage unblinding will be performed and the results of the clinical trial will be further analyzed by revealing the corresponding stimulus montage of each group. This study will be implemented at a single center, the Shanghai Mental Health Center (SMHC).
- Conditions
- Impaired Insight
- Being tested
- active-dTMS, sham-dTMS
- Keywords
- Insight, Deep transcranial magnetic stimulation, Self monitoring, Anterior cingulate cortex, Middle temporal gyrus, Theta oscillation
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 | Participants will be intervened with deep transcranial magnetic stimulation (dTMS). Receives: Device: active-dTMS |
| sham-CHR | Sham comparator | Participants, as a control group, will receive sham stimulation. Receives: Device: sham-dTMS |
| active-FES | Active comparator | Patients with first-episode schizophrenia will be intervened with deep transcranial magnetic stimulation (dTMS). Receives: Device: active-dTMS |
| sham-FES | Sham comparator | Patients with first-episode schizophrenia, 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.
Change in clinical insight
Clinical insight will be assessed using SAI. SAI is a semi-structured interview tools including seven items, with a total score of 14, 0-6 for recognition of illness, 0-4 for relabeling of psychotic phenomena, and 0-4 for treatment compliance. Patients, with less than 3 scores on recognition of illness, 2 on relabeling of psychotic phenomena, and 2 on treatment compliance, are considered to be improved on insight.
Measured: Baseline and immediately after the intervention
Change in error-related negativity
The error-related negativity (ERN) is observed over frontocentral sites within 100 ms following an error response in behavioral tasks, reflecting error-detecting activity, 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
Change in Resting-state functional brain connectivity between anterior cingulate cortex (ACC) and middle temporal gyrus (MTG)
Imaging data will be collected on a 3-T Siemens Magnetom Verio syngo MR B17 scanner and a 32-channel head coil, including structural phase and resting stage detection, which will be used to analyze the functional connection between ACC and MTG.
Measured: Baseline and immediately after the intervention
Secondary outcomes (5)
Change in 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
Covariant change of clinical insight and psychopathological symptoms
Clinical insight will be assessed using SAI, and the psychopathological symptoms will be measured using PANSS. The correlation of psychopathological symptoms with clinical insight will be analyzed, especially possible covariant change after dTMS treatment.
Measured: Baseline and immediately after the intervention
Change in 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
Change in theta oscillation in ACC and theta-alpha phase synchronization between ACC and MTG
Theta oscillation and theta-alpha phase synchronization will be recorded using using a magnetic resonance compatible 64 electrode cap (BrainAMP MR, Brain Products, Munich, Germany) based on the international society for electroencephala 10/20 standard system.
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: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Because this research is a modification of a previous study that was not obtained, and the intervention method has changed significantly, we are considering withdrawing this study and reapplying.
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.
- 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
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jijun Wang, Doctoral, Study chair, Shanghai Mental Health CenterTianhong Zhang, Doctoral, Study director, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513132
- Sponsor's protocol ID
- DTMS2024
- Status last verified
- Jan 2023
- First submitted
- 5 Aug 2020
- Last updated
- 24 Dec 2024
- 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 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Targeted Intervention for Insight in Patients with First Episode and Clinical High Risk of Schizophrenia Based on Theta Oscillation in Anterior Cingulate Cortex
- ClinicalTrials.gov ID
- NCT04513132
- Acronym / sponsor ID
- DTMS2024
- Conditions
- Impaired Insight
- Keywords
- Insight, Deep transcranial magnetic stimulation, Self monitoring, Anterior cingulate cortex, Middle temporal gyrus, Theta oscillation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because this research is a modification of a previous study that was not obtained, and the intervention method has changed significantly, we are considering withdrawing this study and reapplying.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Aug 2020 (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 reflecting the function of self monitoring was a potential objective marker of impaired insight. And further functional magnetic resonance imaging (fMRI) analysis showed that the functional connectivity between anterior cingulate gyrus (ACC) and medial temporal gyrus (MTG) was related to insight. Studies have shown that ACC theta oscillation is the key to self monitoring, and theta-alpha phase synchronization between frontotemporal is closely related to cognition. Therefore, this project hypothesized that targeted regulation of ACC theta oscillations could promote theta-alpha phase synchronization and functional connectivity between ACC and MTG, thereby improving patients' insight. The first-episode and high-risk subjects were recruited to detect the theta oscillation of ACC, theta-Alpha phase synchronization and functional connectivity between ACC and MTG using EEG-fMRI. Deep transcranial magnetic stimulation was introduced to regulate ACC theta oscillations. The high-risk subjects were followed up for two years. It was estimated that the theta-alpha phase synchronization of ACC-MTG and insight in the active-dTMS group were significantly improved. And the outcome of the high-risk subjects is better. The project develops neuroregulatory techniques for impaired insight of schizophrenia and is expected to provide a solution for this clinical pain point.
Detailed description
The study will conduct randomized and controlled experimental design, including deep transcranial magnetic stimulation (dTMS) and sham stimulation (SH-dTMS). Each included participant will be given informed consent and then randomly assigned to different montage of stimulation. Participants are blind to the dTMS montage. Researchers in this study will include clinical evaluators, laboratory inspectors, dTMS operators, and statistical analysts. Before unblinding, each group of researchers will have no access to the information collected by the other groups. For example, except the dTMS operators, no one knows which stimulus montage any of the participants receive. 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. Clinical assessments and laboratory tests will be administered at baseline and at the end of the last session. After the post-intervention tests, first stage unblinding will be conducted. At this moment, dTMS operators will provide the groups of A and B, but no corresponding montage, to the statistical analysts. After analyzing the differences between the two groups, second stage unblinding will be performed and the results of the clinical trial will be further analyzed by revealing the corresponding stimulus montage of each group. This study will be implemented at a single center, the Shanghai Mental Health Center (SMHC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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-dTMSParticipants will be intervened with deep transcranial magnetic stimulation (dTMS). |
| sham-CHR | Sham comparator | Device: sham-dTMSParticipants, as a control group, will receive sham stimulation. |
| active-FES | Active comparator | Device: active-dTMSPatients with first-episode schizophrenia will be intervened with deep transcranial magnetic stimulation (dTMS). |
| sham-FES | Sham comparator | Device: sham-dTMSPatients with first-episode schizophrenia, 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 (5 listed)
- 14~35 years old;
- 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;
- 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-FES |
| 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-FES |
Primary outcome
Change in clinical insight
Time frame: Baseline and immediately after the intervention
Clinical insight will be assessed using SAI. SAI is a semi-structured interview tools including seven items, with a total score of 14, 0-6 for recognition of illness, 0-4 for relabeling of psychotic phenomena, and 0-4 for treatment compliance. Patients, with less than 3 scores on recognition of illness, 2 on relabeling of psychotic phenomena, and 2 on treatment compliance, are considered to be improved on insight.
Change in error-related negativity
Time frame: Baseline and immediately after the intervention
The error-related negativity (ERN) is observed over frontocentral sites within 100 ms following an error response in behavioral tasks, reflecting error-detecting activity, 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.
Change in Resting-state functional brain connectivity between anterior cingulate cortex (ACC) and middle temporal gyrus (MTG)
Time frame: Baseline and immediately after the intervention
Imaging data will be collected on a 3-T Siemens Magnetom Verio syngo MR B17 scanner and a 32-channel head coil, including structural phase and resting stage detection, which will be used to analyze the functional connection between ACC and MTG.
5 secondary outcomes
Change in psychopathological symptoms
Time frame: Baseline and immediately after the intervention
Covariant change of clinical insight and psychopathological symptoms
Time frame: Baseline and immediately after the intervention
Change in reality monitoring ability
Time frame: Baseline and immediately after the intervention
Change in theta oscillation in ACC and theta-alpha phase synchronization between ACC and MTG
Time frame: Baseline and immediately after the intervention
Convertion rate of transition into psychosis
Time frame: 2 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 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.
Jijun Wang, Doctoral study chair
Shanghai Mental Health Center
Tianhong Zhang, Doctoral 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 5 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: withdrawn, as of the sponsor's last update on 24 Dec 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 in clinical insight (time frame: Baseline and immediately after the intervention). The study lists 3 primary outcomes in all. 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 24 Dec 2024.