Transcranial Magnetic Stimulation in Patients With Depression and Non-suicidal Self-injury
40 patients around the world
Available in Brazil
This comprehensive clinical trial seeks to explore the potential therapeutic benefits of
Transcranial Magnetic Stimulation (TMS) when used as an adjunctive treatment for young adult
patients grappling with both depression and non-suicidal self-injury (NSSI). The overarching
objectives of this study are multifaceted and aim to address critical questions regarding the
efficacy and underlying mechanisms of TMS in this particular demographic.
The primary research inquiries guiding this investigation are:
Psychiatric Symptom Reduction: Does the incorporation of adjunctive TMS lead to a significant
reduction in psychiatric symptoms among young adults diagnosed with major depressive disorder
and non-suicidal self-injury?
Neuroimaging Markers: Does adjunctive TMS induce any discernible changes in neuroimaging
markers among young adults with major depressive disorder and non-suicidal self-injury? This
involves employing sophisticated functional neuroimaging techniques such as MRI (Magnetic
Resonance Imaging) and fNIRS (functional Near-Infrared Spectroscopy).
Blood Biomarkers: Are there observable effects on blood biomarkers in young adults with major
depressive disorder and non-suicidal self-injury following adjunctive TMS treatment?
To investigate these questions, participants enrolled in the study will undergo an extensive
and thorough clinical evaluation. Additionally, functional neuroimaging tests, encompassing
both MRI and fNIRS, will be administered to gain insights into the neural correlates of TMS
treatment. Furthermore, peripheral blood samples will be collected to analyze potential
changes in blood biomarkers associated with TMS.
The study design incorporates a randomized assignment of participants to one of two
interventions:
Active TMS Intervention: Participants will undergo 20 sessions of TMS utilizing the
intermittent theta burst stimulation (iTBS) protocol.
Sham TMS Intervention: A control group will receive 20 sham sessions involving a placebo
procedure with the TMS equipment.
Following the completion of the intervention phase, participants will undergo additional
clinical assessments, neuroimaging, and blood tests to comprehensively evaluate the impact of
TMS treatment. The subsequent data analysis will involve a rigorous comparison of the two
groups, assessing factors such as the response and remission of internalizing and
externalizing psychiatric symptoms, as well as outcomes related to neuroimaging and blood
tests.
Brain Institute of Rio Grande do Sul
1Research sites
40Patients around the world
This study is for people with
Depression
Requirements for the patient
To 29 Years
All Gender
Medical requirements
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
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
Sites
Instituto do Cérebro do Rio Grande do Sul
Recruiting
Av. Ipiranga, 6690 - Partenon, Porto Alegre - RS, 90610-001, Brazil