Stanford Neuromodulation Therapy (SNT) for Non-suicidal Self-injury (NSSI)

Transcranial Magnetic Stimulation Clinical Trial

Official title:

Stanford Neuromodulation Therapy (SNT) for Non-suicidal Self-injury (NSSI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06139484
• Other study ID #: AHMU-SNT-NSSI
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: November 2023
• Source: Anhui Medical University
• Contact: Kai Wang, PhD
• Phone: +86-0551-62923704
• Email: wangkai1964[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Non-suicidal Self-injury
• Self-Injurious Behavior
• Transcranial Magnetic Stimulation
• Wounds and Injuries

Intervention

Device:
• Transcranial Magnetic Stimulation
The stimulations were performed by Magstim RAPID.

Locations

Country	Name	City	State
China	Anhui Medical University	Hefei

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)
Secondary	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.	baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)
Secondary	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.	baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)
Secondary	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.	baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)