Feasibility, safety, and preliminary efficacy of Low Amplitude Seizure Therapy (LAP-ST)

A proof of concept clinical trial in Man

Nagy Adel Youssef, Emad Sidhom

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Background Current pulse amplitude used in clinical ECT may be higher than needed. Reducing pulse amplitude may improve focality of the electric field and thus cognitive adverse effects. Here we examine the feasibility, safety, and whether Low Pulse Amplitude Seizure Therapy (LAP-ST, 0.5–0.6 A) minimizes cognitive adverse effects while retaining efficacy. Methods Patients with treatment-resistant primary mood (depressive episodes) or psychotic disorders who were clinically indicated to undergo ECT were offered to be enrolled in an open-label study. The study consisted of a full acute course of LAP-ST under standard anesthesia and muscle relaxation. The primary outcome was feasibility of seizure induction. Clinical outcome measures were: time to reorientation (TRO), Mini Mental State Examination, Montgomery Aberg Depression Scale, and Brief Psychiatric Rating Scale, and Clinical Global Impression Scale. Results Twenty-two patients consented for enrollment in the study. LAP-ST was feasible, and all patients had seizures in the first session. Participants had a quick orientation with median TRO of 4.5 min. Treatment was efficacious for both depressive and psychotic symptoms. Limitations Relatively small sample size, non-blinded, and no randomization was performed in this initial proof of concept study. Conclusions This first human preliminary data of a full course of focal LAP-ST demonstrates that seizure induction is feasible. These results, although preliminary, suggest that the LAP-ST compared to the standard ECT techniques may result in less cognitive side effects, but comparable efficacy. Larger studies are needed to replicate these findings.

Original languageEnglish (US)
Pages (from-to)1-6
Number of pages6
JournalJournal of Affective Disorders
Volume222
DOIs
StatePublished - Nov 1 2017

Fingerprint

Seizures
Clinical Trials
Safety
Therapeutics
Depression
Brief Psychiatric Rating Scale
Muscle Relaxation
Depressive Disorder
Random Allocation
Psychotic Disorders
Sample Size
Anesthesia
Outcome Assessment (Health Care)

Keywords

  • ECT
  • Electroconvulsive therapy
  • Focal ECT
  • Low Amplitude Seizure Therapy
  • Mood disorders
  • Psychotic disorders
  • Seizure therapy
  • Seizure threshold, current titration
  • Treatment-resistant depression

ASJC Scopus subject areas

  • Clinical Psychology
  • Psychiatry and Mental health

Cite this

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title = "Feasibility, safety, and preliminary efficacy of Low Amplitude Seizure Therapy (LAP-ST): A proof of concept clinical trial in Man",
abstract = "Background Current pulse amplitude used in clinical ECT may be higher than needed. Reducing pulse amplitude may improve focality of the electric field and thus cognitive adverse effects. Here we examine the feasibility, safety, and whether Low Pulse Amplitude Seizure Therapy (LAP-ST, 0.5–0.6 A) minimizes cognitive adverse effects while retaining efficacy. Methods Patients with treatment-resistant primary mood (depressive episodes) or psychotic disorders who were clinically indicated to undergo ECT were offered to be enrolled in an open-label study. The study consisted of a full acute course of LAP-ST under standard anesthesia and muscle relaxation. The primary outcome was feasibility of seizure induction. Clinical outcome measures were: time to reorientation (TRO), Mini Mental State Examination, Montgomery Aberg Depression Scale, and Brief Psychiatric Rating Scale, and Clinical Global Impression Scale. Results Twenty-two patients consented for enrollment in the study. LAP-ST was feasible, and all patients had seizures in the first session. Participants had a quick orientation with median TRO of 4.5 min. Treatment was efficacious for both depressive and psychotic symptoms. Limitations Relatively small sample size, non-blinded, and no randomization was performed in this initial proof of concept study. Conclusions This first human preliminary data of a full course of focal LAP-ST demonstrates that seizure induction is feasible. These results, although preliminary, suggest that the LAP-ST compared to the standard ECT techniques may result in less cognitive side effects, but comparable efficacy. Larger studies are needed to replicate these findings.",
keywords = "ECT, Electroconvulsive therapy, Focal ECT, Low Amplitude Seizure Therapy, Mood disorders, Psychotic disorders, Seizure therapy, Seizure threshold, current titration, Treatment-resistant depression",
author = "Youssef, {Nagy Adel} and Emad Sidhom",
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language = "English (US)",
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AU - Sidhom, Emad

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N2 - Background Current pulse amplitude used in clinical ECT may be higher than needed. Reducing pulse amplitude may improve focality of the electric field and thus cognitive adverse effects. Here we examine the feasibility, safety, and whether Low Pulse Amplitude Seizure Therapy (LAP-ST, 0.5–0.6 A) minimizes cognitive adverse effects while retaining efficacy. Methods Patients with treatment-resistant primary mood (depressive episodes) or psychotic disorders who were clinically indicated to undergo ECT were offered to be enrolled in an open-label study. The study consisted of a full acute course of LAP-ST under standard anesthesia and muscle relaxation. The primary outcome was feasibility of seizure induction. Clinical outcome measures were: time to reorientation (TRO), Mini Mental State Examination, Montgomery Aberg Depression Scale, and Brief Psychiatric Rating Scale, and Clinical Global Impression Scale. Results Twenty-two patients consented for enrollment in the study. LAP-ST was feasible, and all patients had seizures in the first session. Participants had a quick orientation with median TRO of 4.5 min. Treatment was efficacious for both depressive and psychotic symptoms. Limitations Relatively small sample size, non-blinded, and no randomization was performed in this initial proof of concept study. Conclusions This first human preliminary data of a full course of focal LAP-ST demonstrates that seizure induction is feasible. These results, although preliminary, suggest that the LAP-ST compared to the standard ECT techniques may result in less cognitive side effects, but comparable efficacy. Larger studies are needed to replicate these findings.

AB - Background Current pulse amplitude used in clinical ECT may be higher than needed. Reducing pulse amplitude may improve focality of the electric field and thus cognitive adverse effects. Here we examine the feasibility, safety, and whether Low Pulse Amplitude Seizure Therapy (LAP-ST, 0.5–0.6 A) minimizes cognitive adverse effects while retaining efficacy. Methods Patients with treatment-resistant primary mood (depressive episodes) or psychotic disorders who were clinically indicated to undergo ECT were offered to be enrolled in an open-label study. The study consisted of a full acute course of LAP-ST under standard anesthesia and muscle relaxation. The primary outcome was feasibility of seizure induction. Clinical outcome measures were: time to reorientation (TRO), Mini Mental State Examination, Montgomery Aberg Depression Scale, and Brief Psychiatric Rating Scale, and Clinical Global Impression Scale. Results Twenty-two patients consented for enrollment in the study. LAP-ST was feasible, and all patients had seizures in the first session. Participants had a quick orientation with median TRO of 4.5 min. Treatment was efficacious for both depressive and psychotic symptoms. Limitations Relatively small sample size, non-blinded, and no randomization was performed in this initial proof of concept study. Conclusions This first human preliminary data of a full course of focal LAP-ST demonstrates that seizure induction is feasible. These results, although preliminary, suggest that the LAP-ST compared to the standard ECT techniques may result in less cognitive side effects, but comparable efficacy. Larger studies are needed to replicate these findings.

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