Examining brain mechanisms of TMS in depression and anxiety
Neural Effects of Transcranial Magnetic Stimulation Using Concurrent Functional Magnetic Resonance Imaging
This study is testing how a brain treatment called TMS affects people with depression and anxiety by looking at their brain activity during and after the treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 97 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT06633913 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the neural mechanisms of transcranial magnetic stimulation (TMS) using concurrent functional magnetic resonance imaging (fMRI) in both healthy individuals and patients experiencing high levels of depression and anxiety. Participants will undergo cognitive and emotional assessments, followed by brain scans to identify optimal TMS locations. The study aims to determine the relationship between the immediate effects of single-pulse TMS and the long-term effects of repetitive TMS, as well as how these effects correlate with symptoms of negative affect. Approximately half of the participants will be male and half female, aged 18-65.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-65 with major depressive disorder or generalized anxiety disorder, as well as healthy controls without psychiatric diagnoses.
Not a fit: Patients with epilepsy, seizure disorders, or those with non-MRI-compatible implanted devices will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of TMS effects, potentially leading to improved treatments for depression and anxiety.
How similar studies have performed: Other studies have shown promise in using TMS and fMRI to understand brain mechanisms, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion for patients: * Diagnosis of major depressive disorder * Age greater than or equal to 18 years * Age less than or equal to 65 years * Able to understand and consent for research participation * English-speaking Inclusion for healthy controls: * Report no lifetime psychiatric diagnosis and treatment * scores on Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder Questionnaire (GAD-7) lower than 4 * Age greater than or equal to 18 years * Age less than or equal to 65 years * Able to understand and consent for research participation * English-speaking Exclusion for all subjects: * Age less than 18 years * Age greater than 65 years * With epilepsy or seizure disorder * With implanted ferromagnetic equipment in their face or skull near the stimulation target MRI Exclusion criteria for all subjects: * Implanted device including pacemaker, coronary stent, defibrillator, or neurostimulation device that is not MRI-compatible * Metal in body including bullets, shrapnel, metal slivers * Claustrophobia * Uncontrolled high blood pressure * Blood circulation problems * Opiate medication, antihypertensive medication, or any medication that interferes with blood flow (interferes with fMRI recordings) * Significant heart disease, such as atrial fibrillation * Pregnancy in female participants * Prior exposure to deep brain stimulation, rTMS, or tDCS (transcranial direct current stimulation) therapies * History of neurological or cardiovascular disorders, brain surgery, radiation treatment, brain hemorrhage or tumor, stroke, or diabetes * Significant traumatic brain injury (loss of consciousness, post-injury amnesia, significant radiological/neurological findings, penetrating brain injury) * Refusal to abstain from illicit drug use for duration of the study * Refusal to abstain from alcohol within 24 hours of scans If you would like to participate in the study, click this link to fill out the Screening Form: https://redcap.icts.uiowa.edu/redcap/surveys/?s=DEYHWF8TMCHHW4Y7. Kindly note that our research team will contact you directly only if you meet the eligibility criteria for the study. Due to the high volume of responses, we are unable to reply to individual inquiries or provide feedback about eligibility decisions.
Where this trial is running
Iowa City, Iowa
- University of Iowa Carver College of Medicine — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Study coordinator: Jing Jiang, PHD
- Email: TMS-fMRI-Study@uiowa.edu
- Phone: 319-678-3410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.