Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT06127056
Brief Summary:
To investigate the intervention effect of high-definition transcranial alternating current stimulation (HD-tACS) on patients with Non-suicidal Self-injury (NSSI) and its underlying neural mechanism by magnetic resonance imaging (MRI).
Detailed Description:
Forty patients with Non-suicidal Self-injury (NSSI) diagnosed by DSM-5 were recruited from the Second Affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving high-definition transcranial alternating current stimulation (HD-tACS) treatment after meeting the inclusion criteria and obtaining informed consent. Each participant will complete the clinical evaluation, magnetic resonance imaging (MRI), and HD-tACS treatment conducted by trained researchers at the Second Affiliated Hospital of Anhui Medical University. All the participants were randomized (1:1) to receive an "active HD-tACS" or "sham HD-tACS" treatment protocol. tACS: the central electrode was placed over F3 with return electrodes placed at Fp1, Fz, F7 and C3. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 15 and 15 seconds, respectively) were applied for 20 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as individual alpha frequency (IAF). Sham HD-tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 15 and 15 seconds.
Before and after the treatments, the patients received a battery measure of neuropsychological tests, and MRI scans in multimodalities. The neuropsychological assessment included the Ottawa Self-injury Inventory (OSI), the Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ), the Hamilton Depression Rating Scale (HAMD), the Hamilton Anxiety Rating Scale (HAMA), and Patient Health Questionnaire-15 (PHQ-15) etc.Multimodal MRI includes 3D-T1, rs-fMRI, and DTI. The symptoms of the patients were followed up one and two months after the end of treatments.
Study:
NCT06127056
Study Brief:
Protocol Section:
NCT06127056