NCT06139484

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transcranial Magnetic Stimulation
• Non-suicidal Self-injury

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Stimulation	The stimulations were performed by Magstim RAPID.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-08-30
• Completion: 2024-08-30
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

1 site across 1 country: China