Enhanced Spatial Targeting in ECT Utilizing FEAST
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| ClinicalTrials.gov Identifier: NCT04099342 |
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Recruitment Status :
Recruiting
First Posted : September 23, 2019
Last Update Posted : March 17, 2023
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| Tracking Information | |||||||||
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| First Submitted Date ICMJE | September 10, 2019 | ||||||||
| First Posted Date ICMJE | September 23, 2019 | ||||||||
| Last Update Posted Date | March 17, 2023 | ||||||||
| Actual Study Start Date ICMJE | April 1, 2022 | ||||||||
| Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Enhanced Spatial Targeting in ECT Utilizing FEAST | ||||||||
| Official Title ICMJE | Enhanced Spatial Targeting in ECT Utilizing Focally Electrically-administered Seizure Therapy (FEAST) | ||||||||
| Brief Summary | The purpose of this research study is to find an alternative version of ECT that reduces the negative side effects (mainly memory loss) while still providing patients with relief from depressive symptoms. Previous forms of ECT may use Bilateral (electrodes on both sides of the head) or Right Unilateral (electrodes on one side of the head). Our research focuses on adjusting the placement of electrodes on one side of the head in order to better stimulate the Prefrontal Cortex (PFC) of the brain. By more specifically targeting the PFC, it is predicted that participants will receive the same benefit as ECT but will have fewer negative side effects after the treatment, mainly less memory loss. All other aspects of the treatment will be similar to regular, clinical ECT, including anesthesia and recovery monitoring. To accomplish this stimulation, an adjusted MECTA Spectrum 5000Q device will be used. If successful, this research study will demonstrate a way to improve ECT procedures for all patients suffering from Major Depressive Disorder by minimizing side effects and maintaining or improving efficacy. | ||||||||
| Detailed Description | Study Design: This study will focus on refining FEAST methods by implementing a fixed-current titration and dosing method (800mA; 0.3 ms), testing the optimal directionality of current flow, and confirming specificity of induction of seizures in right orbitofrontal cortex. Twenty patients in an episode of major depression will be enrolled in the initial open-label study. Patients are kept on current medications for at least 2 weeks prior to initiation of therapy and throughout the treatment course. Patients are allowed PRN lorazepam limited to 3 mg/d but not within 10 hours of a FEAST session. Patients will undergo routine clinical care pre-ECT evaluations which include chemistry laboratory tests and an EKG. Patients may also undergo a brain MRI needed for 3D finite element modeling (FEM) to compute individual electric fields for each participant enrolled as well as a follow up MRI after treatment. Once treatment is initiated, patients receive a dose 6 times initial Seizure Threshold (ST) at all treatments except the first, where ST is determined. If insufficient improvement (<40% change from baseline HRSD-24 item, or IDS-SR) after six treatments, the dose will increase by 50% in charge (9 times initial ST). Patients will undergo 6 channel EEG during all treatments. Sessions 2, 3 and 4 will be cross-randomized across FEAST (with typical electrodes placement and current flow directionality configurations), Revere Polarity FEAST and Reverse Configuration FEAST to allow a direct comparison of induced seizure focality. To ensure that each possible treatment sequence (ABC, ACB, BAC, BCA, CAB, CBA, where A=regular FEAST, B=RP FEAST, C=RC FEAST) during visits 2-4 is represented with approximately equal frequency, participants will be allocated to treatment sequence using a block randomization scheme with a block size of 6 participants. Within each block, each treatment sequence appears exactly once, in random order (e.g. 123456, 352641, etc.). In this way, the number of participants allocated to a particular sequence never differs by more than one from any other sequence. The primary measure right frontal to motor connectivity (seizure drive) and time for orientation recovery obtained following these sessions will permit direct comparison between normal configuration, RP FEAST and RC FEAST as well. Preliminary data generated by the investigators suggest that RP polarity FEAST will elicit the most focal seizure with the shortest time for reorientation and fewest amnestic side effects. Study Procedures: A baseline appointment, scheduled at the Treatment Resistant Depression Clinic in Saint Louis Park, will be initially scheduled with potential participants to complete the informed consent process as well as baseline assessments for cognition, mood and quality of life. Participants may also undergo an optional baseline MRI that will consist of individual T1- and T2-weighted MRI scans which will be acquired with isotropic voxel resolution of 0.8 mm through resources located in the MIDB building. These structural data will be processed in the SimNIBS software to create a 3D volume conductor model of the subject's head. These MRI images will be constructed into 3D FEM models to compute non-invasive brain stimulation and electric fields for each participant enrolled. All FEAST clinical procedures performed through Fairview will be documented in EPIC and duplicated in the research team's RedCap database for later analysis. Treatments are given in the morning, 3 times per week. Pharmacological agents are standardized: atropine (0.4 mg IV), methohexital (0.75 mg/kg) and succinylcholine (0.75-1.0 mg/kg). [If methohexital is unavailable, thiopental will be substituted (2.0 mg/kg]. Patients are oxygenated by mask (100% O2) prior to anesthesia and until resumption of spontaneous respiration. Standardized procedures are used to reduce impedance at ECT and EEG electrode sites. The d'Elia unilateral placement is used for conventional RUL ECT. FEAST will involve the 1.25" circular anterior electrode being centered at the measured FP2 position by the 10/20 EEG system, with the posterior cathode electrode (1"x2.5") tangential to the mid-sagittal plain and centered at vertex. FEAST is delivered with a modified MECTA Spectrum 5000Q relative to the commercial device with the capacity for unidirectional stimulation. Follow up appointments halfway through the FEAST treatment series, 1-2 days after treatment, and 1 week after treatment will also be conducted. They will include assessments of cognition, mood and quality of life. A follow up MRI may also be conducted. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Treatment Resistant Depression | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
20 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 31, 2023 | ||||||||
| Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 22 Years to 90 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
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| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04099342 | ||||||||
| Other Study ID Numbers ICMJE | PSYCH-2019-27591 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Current Responsible Party | University of Minnesota | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor ICMJE | University of Minnesota | ||||||||
| Original Study Sponsor ICMJE | Same as current | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | University of Minnesota | ||||||||
| Verification Date | March 2023 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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