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Enhanced Spatial Targeting in ECT Utilizing FEAST

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ClinicalTrials.gov Identifier: NCT04099342
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : May 19, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Device: FEAST Device: FEAST RP Device: FEAST RC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhanced Spatial Targeting in ECT Utilizing Focally Electrically-administered Seizure Therapy (FEAST)
Actual Study Start Date : April 1, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
Experimental: A: FEAST
Focally Electrically-administered Seizure Therapy (FEAST) is a form of Electroconvulsive therapy (ECT) that combines unidirectional stimulation, control of polarity, and an asymmetrical electrode configuration.
Device: FEAST
FEAST with standard electrode configuration and current flow

Device: FEAST RP
FEAST with standard electrode configuration and reversed current flow

Device: FEAST RC
FEAST with standard current flow and reversed electrode configuration

Experimental: B: RP FEAST
Focally Electrically-administered Seizure Therapy (FEAST) with Reversed Polarity (RP) utilizes the same electrode placement as FEAST but a reversed directionality of current flow.
Device: FEAST
FEAST with standard electrode configuration and current flow

Device: FEAST RP
FEAST with standard electrode configuration and reversed current flow

Device: FEAST RC
FEAST with standard current flow and reversed electrode configuration

Experimental: C: RC FEAST
Focally Electrically-administered Seizure Therapy (FEAST) with Reversed Configuration (RC) utilizes the same current flow as FEAST but a reversed electrode configuration.
Device: FEAST
FEAST with standard electrode configuration and current flow

Device: FEAST RP
FEAST with standard electrode configuration and reversed current flow

Device: FEAST RC
FEAST with standard current flow and reversed electrode configuration




Primary Outcome Measures :
  1. Seizure Drive Markers on EEG [ Time Frame: 8 weeks ]
    Electrophysiological markers of the induced seizure will be captured with a 6-lead EEG placed over bilateral frontal, temporal and parietal lobes. Raw data will be collected in MicroVolts while the analysis will summarize connectivity measures. Right prefrontal activity and seizure drive will be contrasted to other regions from which EEG is recorded, to describe the focality of FEAST-induced seizures.

  2. Seizure characteristics on EEG [ Time Frame: 8 weeks ]
    Length of induced seizures is measured by EEG and recorded in seconds. Spectra powers, global and regional intensity will also be analyzed.

  3. Seizure characteristics by motor observation [ Time Frame: 8 weeks ]
    Length of induced seizures is measured by motor observation and recorded in seconds. Spectra powers, global and regional intensity will also be analyzed.


Secondary Outcome Measures :
  1. Change in Hamilton Depression Rating Score (HDRS) [ Time Frame: 8 weeks ]
    Change in HDRS from baseline to completion of each ECT treatment compared among 3 treatments - FEAST, FEAST RP, and FEAST RC. HDRS is a 24-item interview-based tool measuring depression symptoms in the previous week. Scoring is based on only the first 17 items. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Total scores are the sum of the 17 item scores and range from 0 (Normal functioning) to 22 (severe depression).

  2. Change in Inventory for Depressive Symptoms - Self Report (IDS-SR) Score [ Time Frame: 8 weeks ]
    Change in IDS-SR scores from baseline to completion of each ECT treatment compared among 3 treatments - FEAST, FEAST RP, and FEAST RC. IDS-SR is a 30-item self report tool measuring depression symptoms in the previous week. Items are scored from 1 (normal functioning) to 3 (severely impaired) with some items scored on a yes (score of 1) or no (score of zero) basis. Items are summed to calculate the total score, which ranges from 0 (normal functioning) to 84 (severely impaired).

  3. Time to Reorientation [ Time Frame: 8 weeks ]
    Time between subject open eyes immediately after procedure and correctly identifying 4 out of 5 questions on orientation to name, time and space will be noted in seconds.

  4. Amnestic Side Effects [ Time Frame: 8 weeks ]
    Amnestic side effects will be determined via cognitive assessment and compared pre- and post-FEAST treatment.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of major depressive disorder using mini-7 to derive RDC; DSM-IV
  • Pretreatment HRSC score greater than or equal to 18
  • ECT indicated by physician evaluation
  • Willing and capable of providing informed consent as determined by physician evaluation

Exclusion Criteria:

  • History of schizophrenia, schizoaffective disorder, other functional psychosis, or rapid cycling bipolar disorder as determined by mini-7; rapid cycling defined as greater than or equal to four episodes in past year
  • History of neurological illness or insult other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia) determined by physician evaluation and medical history
  • Alcohol or substance abuse or dependence in the past year (RDC) determined by physician evaluation
  • Secondary diagnosis of a delirium, dementia, or amnestic disorder (DSM-IV), pregnancy, or epilepsy determined by physician evaluation
  • Requires especially rapid antidepressant response due to suicidality, psychosis, inanition, psychosocial obligations, etc. determined by physician evaluation
  • ECT in the past six months determined by physician evaluation and medical history
  • Pregnancy as determined by urine pregnancy test and clinical interview

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099342


Contacts
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Contact: Ziad Nahas, MD 612-273-9732 znahas@umn.edu
Contact: Rachel Johnson 952-525-4505 ipl@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Ziad Nahas, MSCR    612-273-9732    znahas@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Ziad Nahas, MD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04099342    
Other Study ID Numbers: PSYCH-2019-27591
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Depressive Disorder, Treatment-Resistant
Depressive Disorder
Mood Disorders
Mental Disorders