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

NCT ID: NCT06148363

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-12-30

Brief Summary

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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

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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

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Transcranial Direct Current Stimulation Non Suicidal Self Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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real stimulation

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.

Group Type ACTIVE_COMPARATOR

High-Definition transcranial Direct Current Stimulation (HD-tDCS)

Intervention Type DEVICE

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.

sham stimulation

In the sham condition, tDCS 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 tDCS twice daily for two weeks.

Group Type SHAM_COMPARATOR

sham High-Definition transcranial Direct Current Stimulation (HD-tDCS)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anhui Medical University

OTHER

Sponsor Role lead

Responsible Party

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WANG KAI

Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Anhui Medical University

Hefei, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kai Wang, PhD

Role: CONTACT

+86-0551-62923704

Yanghua Tian, PhD

Role: CONTACT

+8613955188448

Facility Contacts

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Kai Wang, PhD

Role: primary

+86-0551-62923704

Yanghua Tian, PhD

Role: backup

+8613955188448

Other Identifiers

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AHMU-tDCS-NSSI

Identifier Type: -

Identifier Source: org_study_id