Transcranial Magnetic StimulationNCT06139484
Stanford Neuromodulation Therapy (SNT) for Non-suicidal Self-injury (NSSI)
A study testing Transcranial Magnetic Stimulation in people with Transcranial Magnetic Stimulation and Non-suicidal Self-injury, run by Anhui Medical University at 1 site in China.
Trial summary
To investigate the treatment effect of Stanford Neuromodulation Therapy (SNT) on patients with Non-suicidal Self-injury (NSSI) and the underlying neural mechanism. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Transcranial Magnetic Stimulation, Non-suicidal Self-injury
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 30 Aug 2024
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- the patients were diagnosed by 2 or more senior clinical psychiatrists, meeting DSM-V criteria, and having 1 or more non-suicidal self-injurious behaviors in the last 6 months
- 12-18 years of age
- The medicine has not changed in the 4 weeks prior to or after this study, and if it has to be changed, the treatment medication is required to be at a subtherapeutic dosage level
Who cannot join
- the patients has suicidal ideation, or have committed suicidal behavior
- T1 or T2 weighted phase magnetic resonance images show focal brain lesions
- patients had neurological disorders such as epilepsy, or serious physical illnesses
- patients had history of substance abuse and drug dependence in the last 6 months or use of anticonvulsant drugs in the last 3 months
- patiens had received radial cranial electrical stimulation or magnetic stimulation treatment in the last 3 months, or received electroconvulsive therapy in the last 6 months
- patients had previous significant head trauma or with EEG abnormality in the last 1 month
- body-mounted devices unsuitable for treatment, such as pacemakers, artificial valves and other metal implants.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Medical University
Hefei
Kai Wang, PhD, +86-0551-62923704, wangkai1964@126.com
Yanghua Tian, PhD, +8613955188448, ayfytyh@126.com
About this study
To investigate the treatment effect of Stanford Neuromodulation Therapy (SNT) on patients with Non-suicidal Self-injury (NSSI) and the underlying neural mechanism.
Read the detailed description
This was a open-label clinical trial to assess the efficacy and underlying neural mechanism of SNT among patients with NSSI.
80 patients with NSSI diagnosed by DSM-5 were recruited from the Second Hospital of Anhui Medical University. After meeting the inclusion criteria and obtaining informed consent, All the participants were randomized (1:1) into two groups: SNT group and rTMS group.
Before the treatment, the Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ) was obtained by a trained investigator to assess baseline severity. The patients had receiving a battery measure of neuropsychological tests(Hamilton depression/anxiety scale, Health Questionnaire-15) and magnetic resonance imaging (MRI) scan in multimodalities.
For SNT group, the treatment was performed once a day for 5 consecutive days. A Brainsight neuronavigation system was used to position the TMS coil over the individualized stimulation target at each session. Ten sessions of iTBS were delivered daily, for a total of 18,000 pulses per day. Stimulation was delivered at 90% of resting motor threshold (rMT).
For rTMS group, the treatment was also performed once a day for 5 consecutive days. Two sessions of rTMS were delivered daily. Each rTMS session comprised 100 trains of 4s duration at 10 Hz with inter-train intervals of 26 s (i.e., 4000 pulses per session). Stimulation was delivered at 90% of rMT.
In the second day after the last treatment, all the tests and MRI were reassessed. Patients were instructed to focus their answers on the past 1 week.
The clinical symptom and cognition of participants were followed in one week and one month after the last treatment.
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- Transcranial Magnetic Stimulation, Non-suicidal Self-injury
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
The stimulations were performed by Magstim RAPID.
| Study group | Role | What they receive |
|---|---|---|
| SNT Group | Active comparator | Patients will be treated with neuronavigated transcranial magnetic stimulation. The treatment protocol is 90% motor threshold (RMT) stimulation intensity for 60 cycles of 10 triplet pulses each at a frequency of 50 Hz, in 2-second stimulation sequences (5 Hz) with 8-second intervals. Stimulation treatments were performed hourly. Ten treatments per day (18,000 pulses/day) for 5 consecutive days (90,000 pulses total). Receives: Device: Transcranial Magnetic Stimulation |
| rTMS Group | Other | Patients will be treated with the normal non-neuronavigated transcranial magnetic stimulation. The treatment protocol is 90%-100% RMT stimulation intensity; 10 Hz frequency for 4 seconds with 26 seconds of rest; 4,000 pulses per session; total duration 50 minutes, twice daily (8,000 pulses/day) for 5 days (40,000 pulses total). Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent Non-suicidalself-injury Assessment Questionnaire
The questionnaire consisted of 2 dimensions and 12 items, with 5 options for each item, namely, "none, occasional, sometimes, often and always", and was scored on a 5-point Likert scale from 0 to 4. The score for each item was summed up as the total score of the questionnaire, and the total mean score was divided by the number of items. The total mean score was divided by the number of items, and the higher the total mean score, the more serious the patients' non-suicidal Likert 5 self-injurious behaviors were.
Measured: baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)
Secondary outcomes (3)
Hamilton Depression Rating Scale (HAMD) Score
The HAMD is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome.
Measured: baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)
Hamilton Anxiety Scale (HAMA) Score
The HAMA is a 14-item scale to measure the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating less anxiety symptoms.
Measured: baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)
Patient Health Questionnaire-15 (PHQ-15) scale
The PHQ-15 is a 15-item scale to measure the severity of somatic symptoms, where each item is rated on a scale from 0 to 2. The PHQ-15 total score ranges from 0 to 30, with lower scores indicating less somatic symptoms.
Measured: baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Aug 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Magnetic StimulationStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
- Investigators
- Yanghua Tian, PhD, Study chair, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139484
- Sponsor's protocol ID
- AHMU-SNT-NSSI
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stanford Neuromodulation Therapy (SNT) for Non-suicidal Self-injury (NSSI)
- ClinicalTrials.gov ID
- NCT06139484
- Acronym / sponsor ID
- AHMU-SNT-NSSI
- Keywords
- Transcranial Magnetic Stimulation, Non-suicidal Self-injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 18 Nov 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.
To investigate the treatment effect of Stanford Neuromodulation Therapy (SNT) on patients with Non-suicidal Self-injury (NSSI) and the underlying neural mechanism.
Detailed description
This was a open-label clinical trial to assess the efficacy and underlying neural mechanism of SNT among patients with NSSI.
80 patients with NSSI diagnosed by DSM-5 were recruited from the Second Hospital of Anhui Medical University. After meeting the inclusion criteria and obtaining informed consent, All the participants were randomized (1:1) into two groups: SNT group and rTMS group.
Before the treatment, the Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ) was obtained by a trained investigator to assess baseline severity. The patients had receiving a battery measure of neuropsychological tests(Hamilton depression/anxiety scale, Health Questionnaire-15) and magnetic resonance imaging (MRI) scan in multimodalities.
For SNT group, the treatment was performed once a day for 5 consecutive days. A Brainsight neuronavigation system was used to position the TMS coil over the individualized stimulation target at each session. Ten sessions of iTBS were delivered daily, for a total of 18,000 pulses per day. Stimulation was delivered at 90% of resting motor threshold (rMT).
For rTMS group, the treatment was also performed once a day for 5 consecutive days. Two sessions of rTMS were delivered daily. Each rTMS session comprised 100 trains of 4s duration at 10 Hz with inter-train intervals of 26 s (i.e., 4000 pulses per session). Stimulation was delivered at 90% of rMT.
In the second day after the last treatment, all the tests and MRI were reassessed. Patients were instructed to focus their answers on the past 1 week.
The clinical symptom and cognition of participants were followed in one week and one month after the last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNT Group | Active comparator | Device: Transcranial Magnetic StimulationPatients will be treated with neuronavigated transcranial magnetic stimulation. The treatment protocol is 90% motor threshold (RMT) stimulation intensity for 60 cycles of 10 triplet pulses each at a frequency of 50 Hz, in 2-second stimulation sequences (5 Hz) with 8-second intervals. Stimulation treatments were performed hourly. Ten treatments per day (18,000 pulses/day) for 5 consecutive days (90,000 pulses total). |
| rTMS Group | Other | Device: Transcranial Magnetic StimulationPatients will be treated with the normal non-neuronavigated transcranial magnetic stimulation. The treatment protocol is 90%-100% RMT stimulation intensity; 10 Hz frequency for 4 seconds with 26 seconds of rest; 4,000 pulses per session; total duration 50 minutes, twice daily (8,000 pulses/day) for 5 days (40,000 pulses total). |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- the patients were diagnosed by 2 or more senior clinical psychiatrists, meeting DSM-V criteria, and having 1 or more non-suicidal self-injurious behaviors in the last 6 months
- 12-18 years of age
- The medicine has not changed in the 4 weeks prior to or after this study, and if it has to be changed, the treatment medication is required to be at a subtherapeutic dosage level
Key exclusion criteria (7 listed)
- the patients has suicidal ideation, or have committed suicidal behavior
- T1 or T2 weighted phase magnetic resonance images show focal brain lesions
- patients had neurological disorders such as epilepsy, or serious physical illnesses
- patients had history of substance abuse and drug dependence in the last 6 months or use of anticonvulsant drugs in the last 3 months
- patiens had received radial cranial electrical stimulation or magnetic stimulation treatment in the last 3 months, or received electroconvulsive therapy in the last 6 months
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 |
|---|---|---|
| Transcranial Magnetic StimulationThe stimulations were performed by Magstim RAPID. | Device | SNT Group, rTMS Group |
Primary outcome
Adolescent Non-suicidalself-injury Assessment Questionnaire
Time frame: baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)
The questionnaire consisted of 2 dimensions and 12 items, with 5 options for each item, namely, "none, occasional, sometimes, often and always", and was scored on a 5-point Likert scale from 0 to 4. The score for each item was summed up as the total score of the questionnaire, and the total mean score was divided by the number of items. The total mean score was divided by the number of items, and the higher the total mean score, the more serious the patients' non-suicidal Likert 5 self-injurious behaviors were.
3 secondary outcomes
Hamilton Depression Rating Scale (HAMD) Score
Time frame: baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)
Hamilton Anxiety Scale (HAMA) Score
Time frame: baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)
Patient Health Questionnaire-15 (PHQ-15) scale
Time frame: baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 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.
Yanghua Tian, PhD study chair
Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Transcranial Magnetic Stimulation and Non-suicidal Self-injury, run by Anhui Medical University 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 3 inclusion and 7 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 18 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Wang, PhD (+86-0551-62923704, wangkai1964@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent Non-suicidalself-injury Assessment Questionnaire (time frame: baseline, the second day(immediately after the intervention),the seventh day(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 Nov 2023.