N/A
N=41
Mini Theta Burst TMS in MDD Patients
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04014959 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: 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 % BOLD signal change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Magnetic Stimulation (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jun 2020
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 | — |
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.
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
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.