Using rTMS to Treat Depression

NCT05424224 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IRB-18-0298-CR03
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Repetitive Transcranial Magnetic Stimulation (rTMS) is a promising, novel, non-invasive therapy for depression. In fact, there is an FDA-approved depression protocol to stimulate the dorsolateral prefrontal cortex (dlPFC). Its efficacy and safety have improved significantly with continued research and clinical experience. However, it is not known how to identify potential patients who would benefit most from treatment. The primary goal of this study is to determine if changes in specific electroencephalogram (EEG) parameters after treatment can predict whether patients are responders or non-responders to rTMS. The second objective is to analyze changes in the functional connectivity of specific brain regions in responders compared to non-responders. The hypothesis is that through rTMS treatment, investigators will be able to increase the activity in the frontal region that includes the dorsolateral prefrontal cortex (DLPFC). Scalp EEG signals will be processed in order to compare EEG brain connectivity and Frontal alpha asymmetry index (FAA) to determine if there are differences before and after the treatment. EEG FAA is usually calculated by subtracting the right-side EEG power estimates from the respective counterpart on the other side. According to literature, depressive patients seem to have comparatively higher left frontal alpha power. Cortical activity is related to a reduced EEG power, which is reflected in depressed subjects. On the other hand, higher alpha power could also be interpreted as inhibition. Investigators will try to delineate changes in resting EEG functional connectivity before and after high-frequency left prefrontal rTMS, by using biomarkers such as: time/frequency connectivity, Alpha asymmetry index, among others. TMS also allows cortical properties, such as excitability, inhibition, oscillatory activity and connectivity to be directly probed within a specific region of the cortex. Other studies suggest that alterations in gamma oscillations in the dorsolateral prefrontal cortex and neighboring frontal regions are also potential shared biomarkers in psychiatry, highlighting the potential of EEG signals to help identify suitable biomarkers. Given its relative low cost and ease of use, when compared to brain imaging tools such as magnetic resonance imaging (MRI) or positron emission tomography (PET), EEG could be added to the clinical study so that precise neurophysiological changes before and after treatments can be assessed.

Conditions

Depression

Keywords

Depression; rTMS; EEG

Outcome Measures

Primary Outcomes (1)

• EEG parameters to asses the change

  Resting-state Electroencephalogram (EEG) can serve as an assessment signal that will determine the benefits of the treatment and the efficacy of this procedure. Frequency domain features will be extracted to analyze the change over the time of the treatment. Connectivity maps will be derived for the most important frequency bands( Delta, Theta, Alpha, and Beta).

  Session 1(baseline), Session 10 ( after 2 weeks of treatment), and 30 ( treatment completion)

Study Arms (1)

patients with depression

patients with depression

Device: MagVita

Interventions

MagVita DEVICE

rTMS system

patients with depression

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any adult with symptoms of depression.

You may qualify if:

• Clinical diagnosis of Depression
• must be willing to cooperate.

You may not qualify if:

• implanted electronic devices (e.g., pacemaker, medication pump, brain or vagus nerve stimulator, cochlear implant)
• history of seizures
• intracranial metal (e.g., aneurysm clip)
• inability of the participant to cooperate with the Transcranial Magnetic Stimulation (TMS) session

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Florida International University

Miami, Florida, 33174, United States

Location

Related Publications (4)

• Chu HT, Cheng CM, Liang CS, Chang WH, Juan CH, Huang YZ, Jeng JS, Bai YM, Tsai SJ, Chen MH, Li CT. Efficacy and tolerability of theta-burst stimulation for major depression: A systematic review and meta-analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Mar 2;106:110168. doi: 10.1016/j.pnpbp.2020.110168. Epub 2020 Nov 7.

  PMID: 33166668 RESULT

• McClintock SM, Reti IM, Carpenter LL, McDonald WM, Dubin M, Taylor SF, Cook IA, O'Reardon J, Husain MM, Wall C, Krystal AD, Sampson SM, Morales O, Nelson BG, Latoussakis V, George MS, Lisanby SH; National Network of Depression Centers rTMS Task Group; American Psychiatric Association Council on Research Task Force on Novel Biomarkers and Treatments. Consensus Recommendations for the Clinical Application of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Depression. J Clin Psychiatry. 2018 Jan/Feb;79(1):16cs10905. doi: 10.4088/JCP.16cs10905.

  PMID: 28541649 RESULT

• Noda Y, Zomorrodi R, Saeki T, Rajji TK, Blumberger DM, Daskalakis ZJ, Nakamura M. Resting-state EEG gamma power and theta-gamma coupling enhancement following high-frequency left dorsolateral prefrontal rTMS in patients with depression. Clin Neurophysiol. 2017 Mar;128(3):424-432. doi: 10.1016/j.clinph.2016.12.023. Epub 2017 Jan 9.

  PMID: 28160748 RESULT

• Kelly MS, Oliveira-Maia AJ, Bernstein M, Stern AP, Press DZ, Pascual-Leone A, Boes AD. Initial Response to Transcranial Magnetic Stimulation Treatment for Depression Predicts Subsequent Response. J Neuropsychiatry Clin Neurosci. 2017 Spring;29(2):179-182. doi: 10.1176/appi.neuropsych.16100181. Epub 2016 Nov 30.

  PMID: 27899052 RESULT

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: June 21, 2022
• Study Start: January 9, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-06

Locations

US (1)