Cognitive Recovery After Electroconvulsive Therapy and General Anesthesia

NCT02761330 | Completed Results

• 1 other identifier: 201512110
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This study is geared toward characterizing the recovery of brain activity and cognitive function following treatments of electroconvulsive therapy and ketamine general anesthesia.

Conditions

Depression; Delirium; Seizures; Cognitive Disorders

Keywords

Anesthesia; Electroconvulsive therapy; Delirium; Electroencephalography; Seizures; Depression; Ketamine; Etomidate; Physiological Effects of Drugs; Pharmacologic Actions; Confusion; Mental Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Neurologic Manifestations; Cognitive Disorders

Outcome Measures

Primary Outcomes (2)

• Change in Cognitive Function During Recovery: Rate of Recovery

  A cognitive test battery was administered at 0, 30, 60, 90, and 120 minutes following return of consciousness after general anesthesia on each treatment day (1-6). The data from each treatment day (1-6) were averaged for analyses. Cognition Test Battery: * Psychomotor Vigilance Task (PVT) * Digital Symbol Substitution Task (DSST) * Motor Praxis Task (MP) * Visual Object Learning Task (VOLT) * Abstract Matching (AM) Rate of Recovery for this measure is defined as the time (in inverse hours) for participants to return to their baseline performance for each task.

  0, 30, 60, 90, 120 minutes following return of consciousness, assessed on treatment days 1-6.

• Change in Cognitive Function During Recovery: Initial Decrement

  A cognitive test battery was administered at 0, 30, 60, 90, and 120 minutes following return of consciousness after general anesthesia on each treatment day (1-6). The data from each treatment day (1-6) were averaged for analyses. Cognition Test Battery: * Psychomotor Vigilance Task (PVT) * Digital Symbol Substitution Task (DSST) * Motor Praxis Task (MP) * Visual Object Learning Task (VOLT) * Abstract Matching (AM) Initial Decrement for this measure is defined as the difference between response times (in seconds) at baseline and t=0 for each task.

  0, 30, 60, 90, 120 minutes following return of consciousness, assessed on treatment days 1-6.

Secondary Outcomes (14)

• Delirium Incidence and Severity

  Immediately following return of consciousness (t=0) during treatment days 1-6.

• Suicidality

  assessed at baseline on treatment days 1-6.

• ECT Seizure Duration

  up to days 1-6

• ECT Electrical Dose

  First ECT treatment session during Treatment Week 1

• Subjective Assessment of Whether ECT Was Performed, Determined by Asking the Patient.

  Assessed at 120 minutes after return of responsiveness on treatment days 1-6

Study Arms (3)

Etomidate + ECT

ACTIVE COMPARATOR

General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Procedure: Electroconvulsive Therapy

Ketamine + ECT

EXPERIMENTAL

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Drug: Ketamine; Procedure: Electroconvulsive Therapy

Ketamine alone

SHAM COMPARATOR

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Drug: Ketamine

Interventions

Ketamine DRUG

Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Ketamine + ECT; Ketamine alone

Electroconvulsive Therapy PROCEDURE

Dose of the ECT charge will be determined during titration session prior to randomization.

Also known as: ECT

Etomidate + ECT; Ketamine + ECT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Treatment resistant depression requiring outpatient ECT
• Planned right unilateral ECT stimulation
• English speaking
• Able to provide written informed consent

You may not qualify if:

• Known brain lesion or neurological illness that causes cognitive impairment
• Schizophrenia
• Schizoaffective disorder
• Blindness or deafness or motor impediments that may impair performance for cognitive testing battery
• Inadequate ECT seizure duration with etomidate

Sponsors & Collaborators

• Washington University School of Medicine: lead
• James S McDonnell Foundation: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

• Hickman LB, Kafashan M, Labonte AK, Chan CW, Huels ER, Guay CS, Guan MJ, Ching S, Lenze EJ, Farber NB, Avidan MS, Hogan RE, Palanca BJA. Postictal generalized electroencephalographic suppression following electroconvulsive therapy: Temporal characteristics and impact of anesthetic regimen. Clin Neurophysiol. 2021 Apr;132(4):977-983. doi: 10.1016/j.clinph.2020.12.018. Epub 2021 Jan 28.

  PMID: 33652270 DERIVED

• Hickman LB, Hogan RE, Labonte AK, Kafashan M, Chan CW, Huels ER, Ching S, Lenze EJ, Maccotta L, Eisenman LN, Keith Day B, Farber NB, Avidan MS, Palanca BJA. Voltage-based automated detection of postictal generalized electroencephalographic suppression: Algorithm development and validation. Clin Neurophysiol. 2020 Dec;131(12):2817-2825. doi: 10.1016/j.clinph.2020.08.015. Epub 2020 Sep 11.

  PMID: 33137572 DERIVED

• Palanca BJA, Maybrier HR, Mickle AM, Farber NB, Hogan RE, Trammel ER, Spencer JW, Bohnenkamp DD, Wildes TS, Ching S, Lenze E, Basner M, Kelz MB, Avidan MS. Cognitive and Neurophysiological Recovery Following Electroconvulsive Therapy: A Study Protocol. Front Psychiatry. 2018 May 14;9:171. doi: 10.3389/fpsyt.2018.00171. eCollection 2018.

  PMID: 29867602 DERIVED

MeSH Terms

Conditions

Depression; Delirium; Seizures; Cognitive Dysfunction; Confusion; Mental Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Neurologic Manifestations

Interventions

Ketamine; Electroconvulsive Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Alyssa Labonte
• Organization: Washington Universtiy School of Medicine

alabonte@wustl.edu

314-273-7338

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: April 30, 2016
• First Posted: May 4, 2016
• Study Start: April 1, 2016
• Primary Completion: September 11, 2019
• Study Completion: September 11, 2019
• Last Updated: June 28, 2021
• Results First Posted: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)