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To investigate the treatment effect of Stanford Neuromodulation Therapy (SNT) on patients with Non-suicidal Self-injury (NSSI) and the underlying neural mechanism.
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.
Age
12 - 18 years
Sex
ALL
Healthy Volunteers
No
Anhui Medical University
Hefei, China
Start Date
August 1, 2023
Primary Completion Date
August 30, 2024
Completion Date
August 30, 2024
Last Updated
November 18, 2023
40
ESTIMATED participants
Transcranial Magnetic Stimulation
DEVICE
Lead Sponsor
Anhui Medical University
NCT07369960
NCT05192759
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