Chronic SchizophreniaNCT05809882
Study of Experience of High-frequency Repetitive Transcranial
A study testing Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil in people with Chronic Schizophrenia, run by Rongjun Hospital of Hebei Province Affiliated to North China University of Science and Technology at 1 site in China.
Trial summary
Objective: To understand the personal experience of schizophrenia patients following repetitive transcranial magnetic stimulation (rTMS) and its connection with changes in mental symptoms, thereby enhancing the overall understanding of TMS. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Schizophrenia
- What is being tested?
- Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 20 Feb 2020
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) were aged 18-65 years;
- 2) fulfilled the diagnosis of International Classification of Diseases Edition 10 schizophrenia;
- 3) had been diagnosed with schizophrenia more than five years previously;
- 4) were in a stable condition;
- 5) whose medication remained unchanged during treatment;
- 6) who did not have a history of epilepsy (including drug-derived);
- 7) had no brain trauma or surgery history;
- 8) who accepted treatment voluntarily and provided signed informed consent for inclusion in the study
Who cannot join
- 1) showed contraindications to rTMS intervention;
- 2) had other neuropsychiatric disorders;
- 3) received non-convulsive electroshock treatment a month preceding the start of the study;
- 4) indicated an impulse for attacking actions and engaged in destructive and self-harming behavior;
- 5) experienced generalized or electricity-related delusionsof reference,influence, andpersecution.
Trial locations and contacts
1 site in 1 country.
China1 site
Rongjun Hospital of Hebei Province Affiliated to North China University of Science and Technology
Baoding, Hebei, 071000
About this study
Official title: High-frequency rTMS Therapy Experience
Objective: To understand the personal experience of schizophrenia patients following repetitive transcranial magnetic stimulation (rTMS) and its connection with changes in mental symptoms, thereby enhancing the overall understanding of TMS.
Method: The investigators selected eligible schizophrenia patients for fixed-parameter rTMS treatment. A self-experience checklist post-TMS treatment and positive and negative symptom scales (PANSS) were applied to evaluate the treatment.
Read the detailed description
The investigators recruited male subjects admitted to who met the criteria. They were divided into a control and a treatment group. A double-blind approach was adopted. The subjects were unaware of whether real/pseudo stimulation was applied, and the evaluators did not know the grouping specifics. All of the enrolled cases were tested for stimulation thresholds in the bilateral prefrontal cortex. The TMS treatment device was a Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil. The study group was administered real stimulation. The treatment parameters were as follows: frequency range, 20 Hz; 90% motion threshold; 3 s of stimulation; a 57 s interval; 15 min of stimulation for each side, five times per week for a total of 20 times. For the control group, a 60% motion threshold was set; the remaining parameters were consistent with the study group but with no stimulating energy output. The therapeutic instrument model, appearance, operation process, and sounds when effecting treatment were the same for both groups. A self-experience checklist post-TMS treatment and positive and negative symptom scales (PANSS) were applied to evaluate the treatment.
- Conditions
- Chronic Schizophrenia
- Being tested
- Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coilDevice
frequency range, 20 Hz; 90% motion threshold; 3 s of stimulation; a 57 s interval; 15 min of stimulation for each side, five times per week for a total of 20 times
Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coilDevice
frequency range, 20 Hz，60% motion threshold; 3 s of stimulation; a 57 s interval; 15 min of stimulation for each side, five times per week for a total of 20 times. But with no stimulating energy output.
| Study group | Role | What they receive |
|---|---|---|
| the study group | Experimental | Not described Receives: Device: Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil |
| the control group | Active comparator | Not described Receives: Device: Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-experience checklist post- transcranial magnetic stimulation treatment
Self-experience checklist post- transcranial magnetic stimulation treatment: In the present study, "self-experience" refers to an evaluation of the changes in a patient's self-perception before and after TMS treatment.
Measured: Half an hour
positive and negative symptom scales (PANSS)
It included 30 entries, among which seven were positive, seven were negative, and the remaining 16 entries were general psychopathology scales for assessing the overall severity of schizophrenia using a 7-level score.
Measured: Half an hour
The repeatable battery for the assessment of neuropsychological status
The RBANS scale included 12 test items that were summarized into five sets of neuromental states (five factors), i.e., immediate memory (vocabulary learning and story review), visuospatial structure (graphic depiction and line positioning), language (picture-naming and semantic fluency), attention (digital breadth and symbolic numbers), and delayed memory (vocabulary recall, vocabulary ecognition, story recall, and graphic recall).
Measured: Half an hour
The Insight and Treatment Attitudes Questionnaire (ITAQ)
it includes the subject's understanding of the disease and their attitude towards treatment. A higher score indicated that a patient had better self-knowledge.
Measured: Half an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Mar 2019
- Primary completion31 Jan 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SchizophreniaStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rongjun Hospital of Hebei Province Affiliated to North China University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinfu Wang, Rongjun Hospital of Hebei Province Affiliated to North China University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809882
- Sponsor's protocol ID
- RongjunHebei001
- Status last verified
- Mar 2023
- First submitted
- 17 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-frequency rTMS Therapy Experience
- ClinicalTrials.gov ID
- NCT05809882
- Acronym / sponsor ID
- RongjunHebei001
- Conditions
- Chronic Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Rongjun Hospital of Hebei Province Affiliated to North China University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 12 Apr 2023 (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.
Objective: To understand the personal experience of schizophrenia patients following repetitive transcranial magnetic stimulation (rTMS) and its connection with changes in mental symptoms, thereby enhancing the overall understanding of TMS.
Method: The investigators selected eligible schizophrenia patients for fixed-parameter rTMS treatment. A self-experience checklist post-TMS treatment and positive and negative symptom scales (PANSS) were applied to evaluate the treatment.
Detailed description
The investigators recruited male subjects admitted to who met the criteria. They were divided into a control and a treatment group. A double-blind approach was adopted. The subjects were unaware of whether real/pseudo stimulation was applied, and the evaluators did not know the grouping specifics. All of the enrolled cases were tested for stimulation thresholds in the bilateral prefrontal cortex. The TMS treatment device was a Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil. The study group was administered real stimulation. The treatment parameters were as follows: frequency range, 20 Hz; 90% motion threshold; 3 s of stimulation; a 57 s interval; 15 min of stimulation for each side, five times per week for a total of 20 times. For the control group, a 60% motion threshold was set; the remaining parameters were consistent with the study group but with no stimulating energy output. The therapeutic instrument model, appearance, operation process, and sounds when effecting treatment were the same for both groups. A self-experience checklist post-TMS treatment and positive and negative symptom scales (PANSS) were applied to evaluate the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the study group | Experimental | Device: Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil |
| the control group | Active comparator | Device: Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1) were aged 18-65 years;
- 2) fulfilled the diagnosis of International Classification of Diseases Edition 10 schizophrenia;
- 3) had been diagnosed with schizophrenia more than five years previously;
- 4) were in a stable condition;
- 5) whose medication remained unchanged during treatment;
Key exclusion criteria (5 listed)
- 1) showed contraindications to rTMS intervention;
- 2) had other neuropsychiatric disorders;
- 3) received non-convulsive electroshock treatment a month preceding the start of the study;
- 4) indicated an impulse for attacking actions and engaged in destructive and self-harming behavior;
- 5) experienced generalized or electricity-related delusionsof reference,influence, andpersecution.
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 |
|---|---|---|
| Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coilfrequency range, 20 Hz; 90% motion threshold; 3 s of stimulation; a 57 s interval; 15 min of stimulation for each side, five times per week for a total of 20 times | Device | the study group |
| Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coilfrequency range, 20 Hz，60% motion threshold; 3 s of stimulation; a 57 s interval; 15 min of stimulation for each side, five times per week for a total of 20 times. But with no stimulating energy output. | Device | the control group |
Primary outcome
Self-experience checklist post- transcranial magnetic stimulation treatment
Time frame: Half an hour
Self-experience checklist post- transcranial magnetic stimulation treatment: In the present study, "self-experience" refers to an evaluation of the changes in a patient's self-perception before and after TMS treatment.
positive and negative symptom scales (PANSS)
Time frame: Half an hour
It included 30 entries, among which seven were positive, seven were negative, and the remaining 16 entries were general psychopathology scales for assessing the overall severity of schizophrenia using a 7-level score.
The repeatable battery for the assessment of neuropsychological status
Time frame: Half an hour
The RBANS scale included 12 test items that were summarized into five sets of neuromental states (five factors), i.e., immediate memory (vocabulary learning and story review), visuospatial structure (graphic depiction and line positioning), language (picture-naming and semantic fluency), attention (digital breadth and symbolic numbers), and delayed memory (vocabulary recall, vocabulary ecognition, story recall, and graphic recall).
The Insight and Treatment Attitudes Questionnaire (ITAQ)
Time frame: Half an hour
it includes the subject's understanding of the disease and their attitude towards treatment. A higher score indicated that a patient had better self-knowledge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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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 Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil in people with Chronic Schizophrenia, run by Rongjun Hospital of Hebei Province Affiliated to North China University of Science and Technology 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 12 Apr 2023. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-experience checklist post- transcranial magnetic stimulation treatment (time frame: Half an hour). 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?
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 12 Apr 2023.