Transcranial Magnetic Stimulation in Patients With Depression and Non-suicidal Self-injury

NCT06110585 | Unknown

• 2 other identifiers: 908INSCER908
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to investigate the effects of Transcranial Magnetic Stimulation (TMS) as an adjunctive treatment for young adult patients with depression and non-suicidal self-injury (NSSI). The main questions this study aims to answer are:

• Does adjunctive TMS reduce psychiatric symptoms in young adults with major depressive disorder and non-suicidal self-injury?
• Does adjunctive TMS cause any changes in neuroimaging markers in young adults with major depressive disorder and non-suicidal self-injury?
• Does adjunctive TMS cause any effects on blood biomarkers in young adults with major depressive disorder and non-suicidal self-injury? Participants in this study will undergo an extensive clinical evaluation, functional neuroimaging tests (MRI and fNIRS), and peripheral blood collection. They will be randomly assigned to one of two interventions: (1) 20 sessions of TMS using the intermittent theta burst stimulation (iTBS) protocol, or (2) 20 sham sessions using a placebo procedure with the TMS equipment. After the 20 sessions, additional clinical assessments, neuroimaging and blood tests will be conducted. The data analysis will compare the two groups in terms of response and remission of internalizing and externalizing psychiatric symptoms, as well as neuroimaging and blood tests outcomes.

Conditions

Depressive Disorder, Major; Self-Injurious Behavior

Outcome Measures

Primary Outcomes (5)

• Hamilton Depression Rating Scale

  Proportion of individuals with a 50% or more score reduction between before and after intervention

  Week 1 prior to TMS treatment and week 1 after completion of TMS treatment

• Patient Health Questionnaire-9

  Proportion of individuals with a 50% or more score reduction between before and after intervention

  Week 1 prior to TMS treatment and week 1 after completion of TMS treatment

• Montgomery-Asberg Depression Rating Scale

  Proportion of individuals with a 50% or more score reduction between before and after intervention

  Week 1 prior to TMS treatment and week 1 after completion of TMS treatment

• fMRI assessed neural network connectivity

  Change on functional connectivity

  Week 1 prior to TMS treatment and week 1 after completion of TMS treatment

• fMRI-assessed resting connectivity

  Change (e.g. normalization) of baseline network-level deficits.

  Week 1 prior to TMS treatment and week 1 after completion of TMS treatment

Secondary Outcomes (9)

• Functional Assessment of Self-Mutilation (FASM)

  Week 1 prior to TMS treatment and week 1 after completion of TMS treatment

• Hamilton Depression Rating Scale

  1, 3 , 6 and 12 months after completion of TMS treatment

• Patient Health Questionnaire-9

  1, 3 , 6 and 12 months after completion of TMS treatment

• Montgomery-Asberg Depression Rating Scale

  1, 3 , 6 and 12 months after completion of TMS treatment

• fNIRS- assessed changes in blood oxygenation levels in the brain

  Week 1 prior to TMS treatment and week 1 after completion of TMS treatment

Study Arms (2)

Experimental: rTMS Treatment

EXPERIMENTAL

20 sessions of TMS using the intermittent theta burst stimulation (iTBS) protocol

Procedure: Transcranial Magnetic Stimulation (TMS)

Sham Comparator: Sham Treatment

SHAM COMPARATOR

20 sham sessions using a placebo procedure with the TMS equipment.

Procedure: Sham

Interventions

Transcranial Magnetic Stimulation (TMS) PROCEDURE

The Intermittent Theta Burst Stimulation (iTBS) protocol will be used. This protocol involves bursts of stimulation at the theta frequency range, approximately 5 to 8 Hz. The specific combination utilized combines bursts of pulses at a frequency of 50 Hz, triggered at a rate of 5 Hz. Thus, a burst of 3 pulses is delivered with intervals of 20 ms between them, and this burst is repeated at intervals of 200 ms (i.e., 5 bursts per second). Every second, 15 pulses are delivered.

Experimental: rTMS Treatment

Sham PROCEDURE

A stimulator with an arm containing a non-functional replica of the stimulation coil will be utilized. The application procedures will be identical to those of the active group, except that the device simulating the stimulation coil will not generate a magnetic field, only producing sound cues mimicking a stimulus.

Sham Comparator: Sham Treatment

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brain Institute of Rio Grande do Sul: lead

Study Sites (1)

Instituto do Cérebro do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Self-Injurious Behavior

Interventions

Transcranial Magnetic Stimulation; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Lucas Spanemberg, PhD

  Instituto do Cérebro do Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas Spanemberg, PhD

CONTACT

+555133205900; lucas.spanemberg@pucrs.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 31, 2023
• Study Start: November 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: February 28, 2025
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)