Stanford Neuromodulation Therapy (SNT) for Non-suicidal Self-injury (NSSI)

NCT06139484 | Unknown

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

Brief Summary

To investigate the treatment effect of Stanford Neuromodulation Therapy (SNT) on patients with Non-suicidal Self-injury (NSSI) and the underlying neural mechanism.

Conditions

Transcranial Magnetic Stimulation; Non-suicidal Self-injury

Keywords

Transcranial Magnetic Stimulation; Non-suicidal Self-injury

Outcome Measures

Primary Outcomes (1)

• Adolescent Non-suicidalself-injury Assessment Questionnaire

  The 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, the second day(immediately after the intervention),the seventh day(immediately after the intervention)

Secondary Outcomes (3)

• Hamilton Depression Rating Scale (HAMD) Score

  baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)

• Hamilton Anxiety Scale (HAMA) Score

  baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)

• Patient Health Questionnaire-15 (PHQ-15) scale

  baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)

Study Arms (2)

SNT Group

ACTIVE COMPARATOR

Patients will be treated with neuronavigated transcranial magnetic stimulation. The treatment protocol is 90% motor threshold (RMT) stimulation intensity for 60 cycles of 10 triplet pulses each at a frequency of 50 Hz, in 2-second stimulation sequences (5 Hz) with 8-second intervals. Stimulation treatments were performed hourly. Ten treatments per day (18,000 pulses/day) for 5 consecutive days (90,000 pulses total).

Device: Transcranial Magnetic Stimulation

rTMS Group

OTHER

Patients will be treated with the normal non-neuronavigated transcranial magnetic stimulation. The treatment protocol is 90%-100% RMT stimulation intensity; 10 Hz frequency for 4 seconds with 26 seconds of rest; 4,000 pulses per session; total duration 50 minutes, twice daily (8,000 pulses/day) for 5 days (40,000 pulses total).

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

The stimulations were performed by Magstim RAPID.

SNT Group; rTMS Group

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 patients has suicidal ideation, or have 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 history of substance abuse and drug dependence in the last 6 months or use of anticonvulsant drugs in the last 3 months
• patiens 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 with 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, China

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• 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 6, 2023
• First Posted: November 18, 2023
• Study Start: August 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)