Clinical trial NCT06139484: Stanford Neuromodulation Therapy (SNT) for Non-suicidal Self-injury (NSSI)
Official title: Stanford Neuromodulation Therapy (SNT) for Non-suicidal Self-injury (NSSI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Non-suicidal Self-injury
Keywords: Transcranial Magnetic Stimulation
Non-suicidal Self-injury
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Adolescent Non-suicidalself-injury Assessment Questionnaire
timeFrame: baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)
Secondary outcomes:
measure: Hamilton Depression Rating Scale (HAMD) Score
timeFrame: baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)
measure: Hamilton Anxiety Scale (HAMA) Score
timeFrame: baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)
measure: Patient Health Questionnaire-15 (PHQ-15) scale
timeFrame: baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
Study officials:
affiliation: Anhui Medical University
name: Yanghua Tian, PhD
role: STUDY_CHAIR
References: