Clinical trial NCT04014959: Mini Theta Burst TMS in MDD Patients
Official title: Mini Theta Burst TMS to Promote Brain Plasticity Indexed by fMRI in MDD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: depression
TMS
fMRI
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects receive active TMS to their individualized fMRI-guided target. Participants will first receive TMS in the MRI scanner, then over the course of 3-Day TMS Intervention Regimen, and lastly in a final MRI scan.
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: This study will involve a baseline Magnetic Resonance Imaging (MRI) scan, Transcranial Magnetic Stimulation (TMS), and TMS interleaved with functional MRI (fMRI) scans.

After screening, eligible participants will undergo a 1-hour MRI scan, encompassing structural and functional scans to establish TMS stimulation targets for subsequent visits. During the baseline TMS/fMRI session or pre-intervention TMS/fMRI, single pulses of TMS and a short round of repetitive TMS (rTMS) will be administered to the participant's individualized target while functional MRI scans (fMRI) are collected. Following this, participants will commence a short TMS intervention regimen involving daily rTMS over 3 consecutive days. The day after the intervention, participants will undergo another TMS/fMRI session, or the post-intervention TMS/fMRI, to capture potential changes from the 3-day intervention.

Clinical assessments will be conducted at baseline before the first TMS/fMRI session and again after the final TMS/fMRI session to assess symptom changes.

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

Primary outcomes:
measure: Changes in Evoked Functional Brain Activity Pre/Post Short iTBS Stimulation Before and After the 3-Day TMS Intervention Regimen
timeFrame: 5 days
Secondary outcomes:
measure: Change in Depression, Anxiety and Stress Scale (DASS-21) Score Pre/Post the 3-Day TMS Intervention Regimen
timeFrame: Up to one week
Other outcomes:
measure: Change in Evoked Functional Brain Activity Before and After the 3-Day TMS Intervention Regimen
timeFrame: Up to one week
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Desmond Oathes, PhD
role: PRINCIPAL_INVESTIGATOR
References: