Non-suicidal Self-injury Clinical Trial
Official title:
Intervention Effect of High-Definition Transcranial Alternating Current Stimulation (HD-tACS) on Non-suicidal Self-injury (NSSI)
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).
Status | Recruiting |
Enrollment | 40 |
Est. completion date | July 30, 2024 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Anhui Medical University | Hefei | Anhui |
Lead Sponsor | Collaborator |
---|---|
Anhui Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in the number, frequency, and impulsivity of self-injurious behaviors | 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. | baseline and immediately after the intervention | |
Secondary | Change in Hamilton Depression Rating Scale (HAMD) Score | 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. | baseline and immediately after the intervention | |
Secondary | Change in Hamilton Anxiety Scale (HAMA) Score | 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. | baseline and immediately after the intervention | |
Secondary | Change in Patient Health Questionnaire-15 (PHQ-15) Score | 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. | baseline and immediately after the intervention |
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