Using Transcranial Magnetic Stimulation to treat depression and self-injury in young adults

Transcranial Magnetic Stimulation: Evaluation of Improvement of Transdiagnostic Psychiatric Symptoms and Changes in Functional Neuroiming in Young Adults Patients With Major Depressive Disorder and Non-suicidal Self-injury

This study is trying out Transcranial Magnetic Stimulation (TMS) to see if it can help young adults with depression and self-injury feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 29 Years
• Sex: All
• Sponsor: Brain Institute of Rio Grande do Sul (Research network)
• Locations: 1 site (Porto Alegre, RS)
• Trial ID: NCT06110585 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of Transcranial Magnetic Stimulation (TMS) as an adjunctive treatment for young adults suffering from major depressive disorder and non-suicidal self-injury (NSSI). Participants will undergo a thorough clinical evaluation and be randomly assigned to receive either TMS or sham treatment over 20 sessions. The study aims to assess the reduction of psychiatric symptoms, changes in neuroimaging markers, and effects on blood biomarkers associated with TMS treatment. Advanced imaging techniques such as MRI and fNIRS will be utilized to explore the underlying mechanisms of TMS in this population.

Who should consider this trial

Good fit: Ideal candidates are young adults diagnosed with major depressive disorder and a history of non-suicidal self-injury.

Not a fit: Patients without a current diagnosis of major depressive disorder or those who do not engage in self-injurious behavior may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce depressive symptoms and self-injurious behaviors in young adults.

How similar studies have performed: Other studies have shown promising results with TMS for depression, but its specific application for NSSI in young adults is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Current diagnosis of major depressive disorder by the operational criteria of DSM-5 and non-suicidal self-injury behavior, defined by "engagement in and intentionally self-inflicted harm to the surface of one's body, likely resulting in bleeding, bruising, or pain (e.g., cutting, burning, puncturing, hitting, excessive rubbing), with the expectation that the injury will only lead to minor or moderate physical harm (i.e., no suicidal intent)". (at least one episode in the past year);
* Depression severity score ≥17 points (moderate depression criteria) on the 17-item Hamilton Depression Rating Scale (HAM-D-17);
* Currently receiving psychiatric treatment and/or engaged in psychotherapy with a minimum biweekly frequency;
* Consent to voluntary participation in the study, confirmed by signing the Informed Consent Form;
* Expressed willingness to comply with all study procedures, including imaging examinations and blood tests, with availability during the study, and to communicate with the study team regarding adverse events and other clinically important information;
* Commitment to access continuous psychiatric care before and after study completion;
* In good general health, as evidenced by medical history.

Exclusion Criteria:

* Participants who present pre-established contraindications for undergoing EMT, based on positive responses in the "TMS Adult Safety Screen (TASS)" questionnaire, such as: cochlear implants, brain stimulators (DBS), electrode implants or aneurysm clips, history of previous seizures, use of pacemakers, presence of implantable defibrillators, brain injury (whether vascular, neoplastic, traumatic, infectious, or metabolic);
* Patients who present a moderate to severe suicide risk, as determined by clinical evaluation or requiring psychiatric hospitalization during the recruitment or EMT application period;
* Patients with severe clinical comorbidities or any other reason that impedes self-mobility, preventing attendance at daily EMT sessions;
* Pregnant patients or those of childbearing age who are sexually active without using contraceptive methods.

Where this trial is running

Porto Alegre, RS

• Instituto do Cérebro do Rio Grande do Sul — Porto Alegre, Rs, Brazil (Recruiting)

Study contacts

• Principal investigator: Lucas Spanemberg, PhD — Instituto do Cérebro do Rio Grande do Sul
• Study coordinator: Lucas Spanemberg, PhD

Conditions Depressive Disorder, Major; Self-Injurious Behavior