Status unknownNCT06110585Updated Oct 31, 2023

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

An interventional study of Transcranial Magnetic Stimulation (TMS) and Sham in Depressive Disorder, Major and Self-Injurious Behavior, sponsored by Brain Institute of Rio Grande do Sul. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2023-10-31.

Sponsored by Brain Institute of Rio Grande do Sul · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 18 Years to 29 Years
Sex: All

Study 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.

Read the detailed description

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.

Conditions studied

Depressive Disorder, Major
Self-Injurious Behavior

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In context

Depressive Disorder, Major

2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.

This study's planned enrollment of 40 is below the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

This is the only study on the registry with Brain Institute of Rio Grande do Sul as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 29 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 40 participants (estimated)

Study arms

Experimental
Experimental: rTMS Treatment
20 sessions of TMS using the intermittent theta burst stimulation (iTBS) protocol
Procedure: Transcranial Magnetic Stimulation (TMS)
Sham comparator
Sham Comparator: Sham Treatment
20 sham sessions using a placebo procedure with the TMS equipment.
Procedure: Sham

Interventions

ProcedureTranscranial Magnetic Stimulation (TMS)
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.
ProcedureSham
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.

What researchers measure

Primary outcomes

Hamilton Depression Rating Scale
Proportion of individuals with a 50% or more score reduction between before and after intervention
Time frame: 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
Time frame: 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
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
fMRI assessed neural network connectivity
Change on functional connectivity
Time frame: 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.
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment

Secondary outcomes

Functional Assessment of Self-Mutilation (FASM)
Difference in score between before and after the intervention
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Hamilton Depression Rating Scale
Proportion of individuals with a 50% or more score reduction between before and after intervention
Time frame: 1, 3 , 6 and 12 months after completion of TMS treatment
Patient Health Questionnaire-9
Proportion of individuals with a 50% or more score reduction between before and after intervention
Time frame: 1, 3 , 6 and 12 months 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
Time frame: 1, 3 , 6 and 12 months after completion of TMS treatment
fNIRS- assessed changes in blood oxygenation levels in the brain
Changes in blood oxygenation levels in the brain measured by fNIRS (functional near-infrared spectroscopy) to infer neural activity
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Brain-Derived Neurotrophic Factor (BDNF)
Changes in BDNF levels comparing pre- and post-treatment
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Ciliary Neurotrophic Factor (CNTF)
Changes in CNTF levels comparing pre- and post-treatment
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Glial Cell-Derived Neurotrophic Factor (GDNF)
Changes in GDNF levels comparing pre- and post-treatment
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Nerve Growth Factor (NGF)
Changes in GDNF levels comparing pre- and post-treatment
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment

Study locations

1 of 1 sites recruiting

Instituto do Cérebro do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
- Karoline Flach · Contact · +555133205900
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2023; primary completion for Sep 2024, 10 months later.

Of 612 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 10 months is below that.

Counting every sponsor, half of 652 studies reached it within 30 months; a quarter within 16 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 11, 2023
First posted: Oct 31, 2023
StartEst.: Nov 1, 2023
Primary completionEst.: Sep 30, 2024
CompletionEst.: Feb 28, 2025
Last update: Oct 31, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06110585
Lead sponsor: Brain Institute of Rio Grande do Sul
Responsible party: Sponsor
First posted: Oct 31, 2023
Start date: Nov 1, 2023 (estimated)
Primary completion: Sep 30, 2024 (estimated)
Completion: Feb 28, 2025 (estimated)
Last update: Oct 31, 2023

Study contacts

Lucas Spanemberg, PhD

Contact

lucas.spanemberg@pucrs.br

+555133205900

Lucas Spanemberg, PhD

principal investigator · Instituto do Cérebro do Rio Grande do Sul

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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