Mini Theta Burst TMS in MDD Patients (NARSAD)

University of Pennsylvania

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Device: Transcranial Magnetic Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04014959

825761

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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