Cognitive Recovery After Electroconvulsive Therapy and General Anesthesia
Mots clés
Abstrait
La 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.
Rendez-vous
| Dernière vérification: | 02/29/2020 |
| Première soumission: | 04/29/2016 |
| Inscription estimée soumise: | 05/02/2016 |
| Première publication: | 05/03/2016 |
| Dernière mise à jour soumise: | 03/11/2020 |
| Dernière mise à jour publiée: | 03/15/2020 |
| Date de début réelle de l'étude: | 03/31/2016 |
| Date d'achèvement primaire estimée: | 09/10/2019 |
| Date estimée d'achèvement de l'étude: | 09/10/2019 |
Condition ou maladie
Intervention / traitement
Drug: Ketamine
Procedure: Electroconvulsive Therapy
Phase
Groupes d'armes
| Bras | Intervention / traitement |
|---|---|
| Active Comparator: Etomidate + ECT 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. | |
| Experimental: Ketamine + ECT 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. | |
| Sham Comparator: Ketamine alone 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. |
Critère d'éligibilité
| Âges éligibles aux études | 18 Years À 18 Years |
| Sexes éligibles à l'étude | All |
| Accepte les bénévoles en santé | Oui |
| Critères | 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 |
Résultat
Mesures des résultats primaires
1. Change in cognitive function during recovery [0, 30, 60, 90, 120 minutes following return of consciousness, assessed on treatment days 1-6.]
Mesures des résultats secondaires
1. Change in delta band (0.5-4 Hz) power in the scalp EEG during recovery [baseline, post-ECT from 0-120 minutes during treatments days 1-6]
2. Change in theta band (4-8 Hz) power in the scalp EEG during recovery [baseline, post-ECT from 0-120 minutes during treatments days 1-6]
3. Change in alpha band (8-13 Hz) power in the scalp EEG during recovery [baseline, post-ECT from 0-120 minutes during treatments days 1-6]
4. Change in beta band (13-30 Hz) power in the scalp EEG during recovery [baseline, post-ECT from 0-120 minutes during treatments days 1-6]
5. Change in anterior-posterior functional connectivity in the scalp during recovery [baseline, post-ECT from 0-120 minutes during treatments days 1-6]
6. Change in anterior-posterior phase-lag in the scalp EEG during recovery [baseline, post-ECT from 0-120 minutes during treatments days 1-6]
7. Change in EEG entropy in the scalp EEG during recovery [baseline, post-ECT from 0-120 minutes during treatments days 1-6]
8. Delirium Incidence and Severity [0, 60, 120 minutes after return of consciousness during treatment days 1-6.]
9. Suicidality [assessed on treatment days 1-6]
10. ECT Seizure duration [up to days 1-6]
11. ECT Electrical dose [up to 1 day]
12. 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]
13. Change in mood assessed using the Mood Self-Assessment Manikin [baseline and 120 minutes after return of responsiveness, assessed on treatment days 1-6]
14. Change in Mood based on the depression PROMIS-CAT [baseline and 120 minutes after return of responsiveness, assessed on treatment days 1-6]
