N/A N=14 Randomized Single-blind Basic Science

Cognitive Recovery After Electroconvulsive Therapy and General Anesthesia

Depression · Delirium · Seizures · Cognitive Disorders

Bottom Line

View on ClinicalTrials.gov: NCT02761330 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: Change in Cognitive Function During Recovery: Rate of Recovery — 3.5; 6.3; 24.7; 9.7 inverse hours — p=0.016

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ketamine (Drug); Electroconvulsive Therapy (Procedure)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Cognitive Function During Recovery: Rate of Recovery	3.5; 6.3; 24.7; 9.7; 3.0; 2.9	0.016 sig
PRIMARY Change in Cognitive Function During Recovery: Initial Decrement	0.4; 3.5; 6.8; 2.4; 5.1; 3.1	0.016 sig
SECONDARY Delirium Incidence and Severity	1; 0; 0; 20; 23; 23	—
SECONDARY Suicidality	0.077; 0.077	—
SECONDARY ECT Seizure Duration	—	—
SECONDARY ECT Electrical Dose	32.5	—
SECONDARY Subjective Assessment of Whether ECT Was Performed, Determined by Asking the Patient.	18; 18; 6	—
SECONDARY Change in Mood Assessed Using the Mood Self-Assessment Manikin	-0.266	—
SECONDARY Average Change in Mood Based on the Depression PROMIS-CAT	-0.5108	—
SECONDARY Change in Delta Band (0.5-4 Hz) Relative Power in the Scale EEG During Recovery	-0.064; -0.111; -0.038	0.301
SECONDARY Change in Theta Band (4-8 Hz) Relative Power in the Scalp EEG During Recovery	-0.008; -0.015; 0.015	0.910
SECONDARY Change in Alpha Band (8-13 Hz) Power in the Scalp EEG During Recovery	0.016; 0.053; 0.006	0.164
SECONDARY Change in Beta Band (13-20 Hz) Relative Power in the Scalp EEG During Recovery	-0.001; -0.004; -0.008	0.910
SECONDARY Change in Anterior-Posterior Functional Connectivity in the Scalp During Recovery	-0.014; -0.002; -0.004	0.129
SECONDARY Change in Anterior-Posterior Phase-lag in the Scalp EEG During Recovery	-0.001; -0.049; -0.017	1.000
SECONDARY Change in EEG Entropy in the Scalp EEG During Recovery	-0.018; -0.003; -0.006	0.008 sig

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02761330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.