Non Suicidal Self Injury, Transcranial Direct Current Stimulation
Conditions
Brief 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.
Interventions
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.
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.
Sponsors
Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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 patient has suicidal ideation or has 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 a history of substance abuse and drug dependence in the last 6 months or use of anticonvulsant drugs in the last 3 months patients 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 EEG abnormality in the last 1 month body-mounted devices unsuitable for treatment, such as pacemakers, artificial valves, and other metal implants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the number, frequency, and impulsivity of self-injurious behaviors | baseline and immediately after the intervention | Adolescent Non-suicidal self-injury Assessment 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Depression Rating Scale (HAMD) Score | baseline and immediately after the intervention | 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. |
| Change in Hamilton Anxiety Scale (HAMA) Score | baseline and immediately after the intervention | 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. |
| Change in Patient Health Questionnaire-15 (PHQ-15) Score | baseline and immediately after the intervention | 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. |
Countries
China
Contacts
Primary ContactKai Wang, PhD
Backup ContactYanghua Tian, PhD
Outcome results
None listed