N/A Completed N=41 Basic Science

Mini Theta Burst TMS in MDD Patients

Source: ClinicalTrials.gov NCT04014959 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2024

Primary outcomePrimary: Changes in Evoked Functional Brain Activity Pre/Post Short iTBS Stimulation Before and After the 3-Day TMS Intervention Regimen — -0.2684097; -0.1897918; -0.2640429; -0.4190647 % BOLD signal change — p=<0.001

Summary

This is not a treatment study. In this study, the researchers are primarily interested in examining whether functional MRI (fMRI)-guided transcranial magnetic stimulation (TMS) may be more effective than traditional TMS methods at temporarily influencing neural circuit communication. The investigators test this by combining TMS and fMRI technologies to probe and modulate brain activity. If the novel fMRI-guided TMS stimulation used in this study is more effective than traditional methods, future studies may utilize similar personalized TMS targeting methods to yield even better clinical outcomes.

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Evoked Functional Brain Activity Pre/Post Short iTBS Stimulation Before and After the 3-Day TMS Intervention Regimen	-0.2684097; -0.1897918; -0.2640429; -0.4190647	<0.001 sig
SECONDARY Change in Depression, Anxiety and Stress Scale (DASS-21) Score Pre/Post the 3-Day TMS Intervention Regimen	26.78; 17.61	—

Eligibility Criteria

Inclusion Criteria

18 to 60 years old, inclusive
Right-handed
Currently experiencing a major depressive episode (MDD)
Capacity to give informed consent and follow study procedures
Command of English language to understand/ respond to written and verbal instructions

Exclusion Criteria

MRI contraindications (i.e., metal in body, claustrophobia, etc.)
TMS contraindications (i.e., seizure disorder)
Diagnosis of exclusionary psychiatric disorder (i.e., schizophrenia, bipolar)
Current use of psychiatric medication and unable/ willing to safely withdraw
Refusal to abstain from alcohol or drugs for duration of study
Medication use that reduces seizure threshold
Medication that interferes with blood flow (i.e., opioids, antihypertensive)
Known neurological disorder or significant disability that interferes with study procedures
Woman who is pregnant or breastfeeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04014959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.