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Cognitive Recovery After Electroconvulsive Therapy and General Anesthesia (RCC2)

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The Washington University

Status

Completed

Conditions

Seizures
Delirium
Depression
Cognitive Disorders

Treatments

Drug: Ketamine
Procedure: Electroconvulsive Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02761330
201512110

Details and patient eligibility

About

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

Full description

Seizures are often associated with loss of consciousness, possibly through effects on sub-cortical arousal systems, disruption of cortical-subcortical interactions, and ultimately through depressed neocortical function. Furthermore, people are often confused in the post-ictal state even when consciousness returns after a seizure. Disrupted cognitive function during the postictal phase has not been fully characterized but presents short and long-term implications. Many experience an acute disorder of attention, consciousness, and cognition, referred to as delirium. Memory deficits are also common. The neurobiology for these phenomena are incomplete and challenging to test, as seizures are typically sporadic and vary in intensity and character. In contrast, the setting of electroconvulsive therapy (ECT) provides the opportunity to study the reconstitution of consciousness and cognition following seizures in an elective and predictable context.

There is no standard agent used to induce general anesthesia during ECT. Ketamine is receiving greater attention as an infusion for treating depression and for its potential benefits on improving ECT efficacy and expediting cognitive recovery. Further data are needed to determine whether ketamine may improve recovery of cognitive function relative to etomidate, a commonly used anesthetic for general anesthesia during ECT.

The investigators will evaluate the cognition function and electroencephalographic patterns that accompany the recovery from ECT and general anesthesia. Twenty patients with refractory depression will be randomized in this interventional single-blinded randomized crossover trial. Each patient will complete seven study visits. The first visit will be conducted during the dose-charge titration ECT treatment with etomidate anesthesia. After this session, patients will be randomized to three sessions each week for two weeks (six treatments total). Over the first week patients will be randomized in order for three treatment arms: (1) etomidate general anesthesia and ECT, (2) ketamine general anesthesia and ECT, and (3) ketamine alone. Patients will be blinded to the treatment arm for each session. Baseline and post-treatment measurements of cognition and ECT will be acquired on each of the six treatment sessions.

Patients that agree will have a MRI.

Enrollment

17 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

17 participants in 3 patient groups

Etomidate + ECT
Active Comparator group
Description:
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.
Treatment:
Procedure: Electroconvulsive Therapy
Ketamine + ECT
Experimental group
Description:
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.
Treatment:
Procedure: Electroconvulsive Therapy
Drug: Ketamine
Ketamine alone
Sham Comparator group
Description:
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.
Treatment:
Drug: Ketamine

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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