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

NCT06127056 | Unknown

• 1 other identifier: AHMU-tACS-NSSI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Transcranial Alternating Current Stimulation; Non-suicidal Self-injury

Outcome Measures

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.

  baseline and immediately after the intervention

Secondary Outcomes (3)

• Change in Hamilton Depression Rating Scale (HAMD) Score

  baseline and immediately after the intervention

• Change in Hamilton Anxiety Scale (HAMA) Score

  baseline and immediately after the intervention

• Change in Patient Health Questionnaire-15 (PHQ-15) Score

  baseline and immediately after the intervention

Study Arms (2)

real stimulation

ACTIVE COMPARATOR

The central electrode was placed over F3, with return electrodes 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 IAF.

Device: High-Definition Transcranial Alternating Current Stimulation (HD-tACS)

sham stimulation

SHAM COMPARATOR

In the sham condition, tACS was delivered only during the ramp-up and ramp-down periods (15 and 15 s); no current was delivered during the 20-minute intervention. Participants will receive sham tACS twice daily for two weeks.

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

Interventions

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.

real stimulation

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.

sham stimulation

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, China

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Yanghua Tian, PhD

  Anhui Medical University

  STUDY CHAIR

Central Study Contacts

Kai Wang, PhD

CONTACT

+86-0551-62923704; wangkai1964@126.com

Yanghua Tian, PhD

CONTACT

+8613955188448; ayfytyh@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: May 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

CN (1)