NCT06148363

Intervention Effect of High-Definition Transcranial Direct Current Stimulation (HD-tDCS) on 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 intervention effect of high-definition transcranial Direct Current Stimulation (HD-tDCS) 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 Direct Current Stimulation (HD-tDCS) treatment after meeting the inclusion criteria and obtaining informed consent. Each participant will complete the clinical evaluation, magnetic resonance imaging (MRI), and HD-tDCS 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-tDCS" or "sham HD-tDCS" treatment protocol. tDCS: 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. Sham HD-tDCS 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.

Conditions

• Transcranial Direct Current Stimulation
• Non Suicidal Self Injury

Interventions

Type	Name	Description
DEVICE	High-Definition transcranial Direct Current Stimulation (HD-tDCS)	tDCS, or Transcranial Direct Current Stimulation, is a non-invasive brain stimulation technique that involves applying a small, constant direct current through electrodes placed on the scalp to modulate neuronal activity in specific brain regions.
DEVICE	sham High-Definition transcranial Direct Current Stimulation (HD-tDCS)	In the sham condition, tDCS was delivered only during the ramp-up and ramp-down periods (15s and 15s); no current was delivered during the 20-minute intervention.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2023-11-28
• Last updated: 2023-11-28

Locations

1 site across 1 country: China