Treatment Resistant Schizophrenia Based on the DTMSNCT05167942
Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia
A study testing deep transcranial magnetic stimulation with H1 coil, High frequency deep transcranial magnetic stimulation with H1 coil and iTBS deep transcranial magnetic stimulation with H1 coil in people with Treatment Resistant Schizophrenia Based on the DTMS, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Negative symptoms and cognitive dysfunction are of importance for the prognosis of the patients of schizophrenia. Based on the hypothesis that deep transcranial magnetic stimulation(dTMS) on prefrontal cortex #PFC# could down-regulate the glutamate level of PFC and regulate the functional network in patients with… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Treatment Resistant Schizophrenia Based on the DTMS
- What is being tested?
- deep transcranial magnetic stimulation with H1 coil, High frequency deep transcranial magnetic stimulation with H1 coil and iTBS deep transcranial magnetic stimulation with H1 coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 30 Sep 2023
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients with schizophrenia who meet the dsm-5 diagnostic criteria
- Aged from 18 to 55
- Right-handedness, normal hearing, visual acuity or corrected visual acuity
- Written informed consent of the patient and his/her family
- All patients received MINI 7.0 structured interviews
Who cannot join
- Patients who are currently taking clozapine or who have failed to respond to a full course of treatment with clozapine
- 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
- Medically unstable for at least 1 month
Trial locations and contacts
1 site in 1 country.
About this study
Negative symptoms and cognitive dysfunction are of importance for the prognosis of the patients of schizophrenia. Based on the hypothesis that deep transcranial magnetic stimulation(dTMS) on prefrontal cortex #PFC# could down-regulate the glutamate level of PFC and regulate the functional network in patients with treatment resistance 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 high-frequency deep transcranial magnetic stimulation on SZ patients symptoms,as well as to elucidate the correlation between treatment effects and glutamate level of PFC
Read the detailed description
This study includes 87 treatment resistance schizophrenia patients. This study will investigate 1)abnormalities of the glutamate level of PFC in patients with schizophrenia compared to healthy controls by using 1H-MRS technique. 2)potential modulation effects of deep transcranial magnetic stimulation(dTMS) on prefrontal cortex function of patients with schizophrenia. 3)the therapeutic efficacy of dTMS 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 dTMS treatment pattern on cognitive function.
- Being tested
- deep transcranial magnetic stimulation with H1 coil, High frequency deep transcranial magnetic stimulation with H1 coil, iTBS deep transcranial magnetic stimulation with H1 coil
- Keywords
- Deep Transcranial Magnetic Stimulation, Treatment Resistant Schizophrenia, H1 coil
- Medical subject headings
- Schizophrenia, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep transcranial magnetic stimulation with H1 coilDevice
Sham deep transcranial magnetic stimulation on PFC .Duration:40 days.
High frequency deep transcranial magnetic stimulation with H1 coilDevice
high frequency(20Hz) deep transcranial magnetic stimulation on PFC .Duration:40 days.
iTBS deep transcranial magnetic stimulation with H1 coilDevice
iTBS deep transcranial magnetic stimulation on PFC .Duration:40 days.
| Study group | Role | What they receive |
|---|---|---|
| Sham dTMS | Sham comparator | 29 patients will be randomly allocated into this group,they will receive sham stimulation. Receives: Device: deep transcranial magnetic stimulation with H1 coil |
| dTMS 20Hz | Active comparator | 29 patients will be randomly allocated into this group,they will receive real stimulation. Receives: Device: High frequency deep transcranial magnetic stimulation with H1 coil |
| dTMS iTBS | Active comparator | 29 patients will be randomly allocated into this group,they will receive real stimulation. Receives: Device: iTBS deep transcranial magnetic stimulation with H1 coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Positive and Negative Syndrome Scale(PANSS)
Change from baseline in Positive and Negative Syndrome Scale(PANSS) after dtms treat 40 days
Measured: baseline,24 hours after the dTMS treatment,40 days
Change from baseline in MATRICS Consensus Cognitive Battery
MATRICS Consensus Cognitive Battery
Measured: baseline,24 hours after the rTMS treatment,40 days
Secondary outcomes (1)
Change of PFC neurogenesis
Quantify neural stem cells in hippocampal by using H1-MRS
Measured: baseline,24 hours after the dTMS treatment,40days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Nov 2021
- Primary completionSep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant Schizophrenia Based on the DTMSStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167942
- Sponsor's protocol ID
- 20y11906300
- Status last verified
- Nov 2021
- First submitted
- 10 Dec 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia
- ClinicalTrials.gov ID
- NCT05167942
- Acronym / sponsor ID
- 20y11906300
- Keywords
- Deep Transcranial Magnetic Stimulation, Treatment Resistant Schizophrenia, H1 coil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 22 Dec 2021 (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.
Negative symptoms and cognitive dysfunction are of importance for the prognosis of the patients of schizophrenia. Based on the hypothesis that deep transcranial magnetic stimulation(dTMS) on prefrontal cortex #PFC# could down-regulate the glutamate level of PFC and regulate the functional network in patients with treatment resistance 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 high-frequency deep transcranial magnetic stimulation on SZ patients symptoms,as well as to elucidate the correlation between treatment effects and glutamate level of PFC
Detailed description
This study includes 87 treatment resistance schizophrenia patients. This study will investigate 1)abnormalities of the glutamate level of PFC in patients with schizophrenia compared to healthy controls by using 1H-MRS technique. 2)potential modulation effects of deep transcranial magnetic stimulation(dTMS) on prefrontal cortex function of patients with schizophrenia. 3)the therapeutic efficacy of dTMS 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 dTMS treatment pattern on cognitive function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham dTMS | Sham comparator | Device: deep transcranial magnetic stimulation with H1 coil29 patients will be randomly allocated into this group,they will receive sham stimulation. |
| dTMS 20Hz | Active comparator | Device: High frequency deep transcranial magnetic stimulation with H1 coil29 patients will be randomly allocated into this group,they will receive real stimulation. |
| dTMS iTBS | Active comparator | Device: iTBS deep transcranial magnetic stimulation with H1 coil29 patients will be randomly allocated into this group,they will receive real stimulation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with schizophrenia who meet the dsm-5 diagnostic criteria
- Aged from 18 to 55
- Right-handedness, normal hearing, visual acuity or corrected visual acuity
- Written informed consent of the patient and his/her family
- All patients received MINI 7.0 structured interviews
Key exclusion criteria (3 listed)
- Patients who are currently taking clozapine or who have failed to respond to a full course of treatment with clozapine
- 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
- Medically unstable for at least 1 month
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 |
|---|---|---|
| deep transcranial magnetic stimulation with H1 coilSham deep transcranial magnetic stimulation on PFC .Duration:40 days. | Device | Sham dTMS |
| High frequency deep transcranial magnetic stimulation with H1 coilhigh frequency(20Hz) deep transcranial magnetic stimulation on PFC .Duration:40 days. | Device | dTMS 20Hz |
| iTBS deep transcranial magnetic stimulation with H1 coiliTBS deep transcranial magnetic stimulation on PFC .Duration:40 days. | Device | dTMS iTBS |
Primary outcome
Change from baseline in Positive and Negative Syndrome Scale(PANSS)
Time frame: baseline,24 hours after the dTMS treatment,40 days
Change from baseline in Positive and Negative Syndrome Scale(PANSS) after dtms treat 40 days
Change from baseline in MATRICS Consensus Cognitive Battery
Time frame: baseline,24 hours after the rTMS treatment,40 days
MATRICS Consensus Cognitive Battery
1 secondary outcome
Change of PFC neurogenesis
Time frame: baseline,24 hours after the dTMS treatment,40days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
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 deep transcranial magnetic stimulation with H1 coil, High frequency deep transcranial magnetic stimulation with H1 coil and iTBS deep transcranial magnetic stimulation with H1 coil in people with Treatment Resistant Schizophrenia Based on the DTMS, 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 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 22 Dec 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?
Contact Dengtang Liu, M.D. (8618017311138, erliu110@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Positive and Negative Syndrome Scale(PANSS) (time frame: baseline,24 hours after the dTMS treatment,40 days). The study lists 2 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 22 Dec 2021.