Closed-Loop Electroencephalography Optimized Transcranial Magnetic Stimulation Pilot Study For Advanced Treatment Outcomes In Adults With Major Depressive Disorder (CLEOPATRA)

Overview

About this study

The purpose of this study is to examine the feasibility of closed-loop iTBS-EEG with stimulation bursts delivered at the trough of theta waves (n=20), closed-loop iTBS-EEG with stimulation bursts delivered at the peak of theta waves (n=20) or closed-loop iTBS-EEG with stimulation bursts delivered at random phase (n=20).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Outpatients

  • Voluntary and have the capacity to consent

  • Have Major Depressive Disorder (MDD) single or recurrent episodes confirmed with the Mini-International Neuropsychiatric Interview (MINI)

  • Are aged 22-60 years

  • Failed to achieve a clinical response to an adequately dosed antidepressant as assessed with a Antidepressant Treatment History Form score of 3 or greater in the current episode or have had 2 separate trials of antidepressants that were intolerable

  • Have a score of 18 or higher on the Hamilton Depression Rating Scale (17 item) HDRS

  • Have no initiation or dose change in any psychotropic medication for the 4 weeks prior to screening

  • Are able to adhere to the protocol and treatment schedule

  • Can safely undergo iTBS treatment  based on the TMS Adult Safety Screen questionnaire.

Exclusion Criteria:

  • Have a history of a substance use disorder within the past 3 months

  • Have a major medical illness, cardiac pacemaker, implanted devices, or implanted medication pumps

  • Have active suicidal intent

  • Are pregnant

  • Based on the MINI interview have lifetime diagnosis of bipolar I, bipolar II, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or any current psychotic symptoms

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/08/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Paul Croarkin, D.O., M.S.

Open for enrollment

Contact information:

Courtney Caves

5072550624

wolf.courtney@mayo.edu

More information

Publications

  • New antidepressant treatments are needed that are effective, rapid acting, safe, and tolerable. Intermittent theta-burst stimulation (iTBS) is a noninvasive brain stimulation treatment that has been approved by the U.S. Food and Drug Administration for treatment-resistant depression. Recent methodological advances suggest that the current iTBS protocol might be improved through 1) treating patients with multiple sessions per day at optimally spaced intervals, 2) applying a higher overall pulse dose of stimulation, and 3) precision targeting of the left dorsolateral prefrontal cortex (DLPFC) to subgenual anterior cingulate cortex (sgACC) circuit. The authors examined the feasibility, tolerability, and preliminary efficacy of Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), an accelerated, high-dose resting-state functional connectivity MRI (fcMRI)-guided iTBS protocol for treatment-resistant depression. Read More on PubMed
  • Real-time approaches for transcranial magnetic stimulation (TMS) based on a specific EEG phase are a promising avenue for more precise neuromodulation interventions. However, optimal approaches to reliably extract the EEG phase in a frequency band of interest to inform TMS are still to be identified. Here, we implement a new real-time phase detection method for closed-loop EEG-TMS for robust phase extraction. We compare this algorithm with state-of-the-art methods and evaluate its performance both in silico and experimentally. Read More on PubMed
  • Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for refractory major depressive disorder, yet no studies have characterized trajectories of rTMS response. The aim of this study was to characterize response trajectories for patients with major depression undergoing left dorsolateral prefrontal cortex rTMS and to determine associated baseline clinical characteristics. Read More on PubMed
  • The optimal target in the dorsolateral prefrontal cortex for treating depression with repetitive transcranial magnetic stimulation (rTMS) remains unknown. Better efficacy has been associated with stimulation sites that are 1) more anterior and lateral and 2) more functionally connected to the subgenual cingulate. Here we prospectively test whether these factors predict response in individual patients. Read More on PubMed
  • Treatment-resistant major depressive disorder is common; repetitive transcranial magnetic stimulation (rTMS) by use of high-frequency (10 Hz) left-side dorsolateral prefrontal cortex stimulation is an evidence-based treatment for this disorder. Intermittent theta burst stimulation (iTBS) is a newer form of rTMS that can be delivered in 3 min, versus 37·5 min for a standard 10 Hz treatment session. We aimed to establish the clinical effectiveness, safety, and tolerability of iTBS compared with standard 10 Hz rTMS in adults with treatment-resistant depression. Read More on PubMed