Intervention Effect of High-Definition Transcranial Alternating Current Stimulation (HD-tACS) on Non-suicidal Self-injury (NSSI)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorAnhui Medical University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-Definition Transcranial Alternating Current Stimulation (HD-tACS)

    Device

    tACS is described as a non-invasive form of brain stimulation that uses a low-intensity, alternating current applied directly to the head through scalp electrodes.

  • sham High-Definition Transcranial Alternating Current Stimulation (HD-tACS)

    Device

    In the sham condition, tACS was delivered only during the ramp-up and ramp-down periods (15s and 15s); no current was delivered during the 20-minute intervention.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: real stimulationActive comparator 1 intervention
Group B: sham stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline and immediately after the intervention

Secondary outcomes

1

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.

Time frame
baseline and immediately after the intervention
2

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.

Time frame
baseline and immediately after the intervention
3

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.

Time frame
baseline and immediately after the intervention

Other outcomes

Sponsors and contacts

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