N/A
Completed N=14
Cognitive Recovery After Electroconvulsive Therapy and General Anesthesia
Depression · Delirium · Seizures · Cognitive Disorders
Source: ClinicalTrials.gov NCT02761330 ↗
Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Change in Cognitive Function During Recovery: Rate of Recovery — 3.5; 6.3; 24.7; 9.7 inverse hours — p=0.016
Summary
This study is geared toward characterizing the recovery of brain activity and cognitive function following treatments of electroconvulsive therapy and ketamine general anesthesia.
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 |
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
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. Informational only — not medical advice.