NCT07527234

Brief Summary

Electroconvulsive therapy (ECT) is one of the oldest biological treatment methods used in psychiatry, based on inducing widespread seizures in the brain with externally applied controlled electrical currents. It was first applied in 1938 by Italian physician Ugo Cerletti and his assistant Lucio Bini. A 1974 report by the American Psychiatric Association stated that ECT was effective in treating depression, mania, and refractory schizophrenia, and it is still used today as an effective and safe method, particularly in the treatment of severe major depression, catatonia, schizophrenia, and mania. Although the exact mechanism of action of ECT is not fully understood, it is suggested that it increases brain receptor sensitivity, accelerates serotonin and dopamine metabolism, activates monoaminergic systems, regulates the circadian rhythm, and provides synchronization between brain hemispheres. In addition, it has been shown to affect neurotransmitter levels, neuroendocrine responses, and neurogenesis processes. Anterograde and retrograde amnesia are among the cognitive side effects that can be seen in the subacute phase of ECT. While anterograde amnesia usually resolves within a few months after treatment, retrograde amnesia can be permanent in some cases. Therefore, assessment of cognitive function before, during, and after ECT is recommended. In clinical practice, the Montreal Cognitive Assessment (MoCA) and the Mini-Mental State Test (MMSE) are frequently used for cognitive assessment. However, these scales were not developed to assess ECT-specific cognitive effects and may be limited in detecting retrograde memory loss, autobiographical memory impairments, and subjective memory complaints. Therefore, there is a need for more sensitive tools that can assess ECT-specific cognitive side effects. The Electroconvulsive Cognitive Assessment Test (ECCA), developed for this purpose by Adriana P. Hermida and colleagues from the Department of Psychiatry and Behavioral Sciences at Emory University in Atlanta, is a structured assessment tool consisting of 30 items. The test; The ECCA assesses five cognitive domains: subjective memory, caregiver-assessed memory, attention, autobiographical memory, and delayed verbal recall. A study in the UK compared the ECCA with the MoCA and showed that the ECCA may be more sensitive in assessing cognitive function in individuals undergoing ECT. Similarly, a study in China reported that the ECCA was more sensitive than the MMSE and MoCA in assessing cognitive changes in patients with major depressive disorder after ECT. In conclusion, the limitations of current tools in assessing cognitive function during ECT necessitate the development of ECT-specific measurement tools. In this context, the ECCA is considered an important tool for clinical decision-making and post-treatment cognitive monitoring. Scales are measurement tools used to classify and rate the characteristics to be measured. Scale adaptation studies save time compared to developing a new scale and allow the use of common data collection tools in different cultures. Therefore, conducting validity and reliability studies of tests is of great scientific importance. To conduct a validity and reliability study of the ECCA test in Turkey, the necessary permission was obtained from the test developer, Adriana Hermida. During the translation process, the test was translated from English to Turkish by five independent individuals, and then back-translated by five different individuals. The translations were compared to ensure consistency, and the process was also verified by a sworn translator.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Jul 2025Nov 2026

Study Start

First participant enrolled

July 8, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2026

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

March 13, 2026

Last Update Submit

April 6, 2026

Conditions

Keywords

Electroconvulsive therapyElectroconvulsive Therapy Cognitive Assessment (ECCA)Turkish adaptationMontreal Cognitive Assessment (MoCA)

Outcome Measures

Primary Outcomes (1)

  • ecca test

    The Electroconvulsive Cognitive Assessment (ECCA) is a brief cognitive assessment tool developed to evaluate cognitive functions in patients receiving electroconvulsive therapy (ECT). It is designed to assess cognitive domains that may be affected by ECT, including memory, attention, and subjective cognitive complaints. The test is used to monitor cognitive changes during the course of ECT treatment.

    periprocedural

Secondary Outcomes (2)

  • ace-r test

    periprocedural

  • moca test

    periprocedural

Other Outcomes (1)

  • Mini-Mental State Examination (MMSE)

    periprocedural

Study Arms (1)

ect patients

patients who have received ECT indication

Device: ElectroConvulsive Therapy Cognitive Assessment (ECCA)

Interventions

The ElectroConvulsive Therapy Cognitive Assessment (ECCA) is a brief cognitive assessment tool specifically developed to evaluate cognitive functions in patients undergoing electroconvulsive therapy (ECT). In this study, the Turkish version of the ECCA will be administered to assess its validity and reliability and to compare its performance with other neuropsychological assessment tools. The intervention in this study refers to the administration of the ECCA as an assessment instrument rather than a therapeutic procedure.

ect patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all patients receiving ect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale Univercity

Denizli, Turkey (Türkiye)

Location

Related Publications (3)

  • McCall WV, Andrade C, Sienaert P. Searching for the mechanism(s) of ECT's therapeutic effect. J ECT. 2014 Jun;30(2):87-9. doi: 10.1097/YCT.0000000000000121.

    PMID: 24755719BACKGROUND
  • Hebbrecht K, Giltay EJ, Birkenhager TK, Sabbe B, Verwijk E, Obbels J, Roelant E, Schrijvers D, Van Diermen L. Cognitive change after electroconvulsive therapy in mood disorders measured with the Montreal Cognitive Assessment. Acta Psychiatr Scand. 2020 Nov;142(5):413-422. doi: 10.1111/acps.13231. Epub 2020 Sep 21.

    PMID: 32895922BACKGROUND
  • Hermida AP, Goldstein FC, Loring DW, McClintock SM, Weiner RD, Reti IM, Janjua AU, Ye Z, Peng L, Tang YL, Galendez GC, Husain MM, Maixner DF, Riva-Posse P, McDonald WM; National Network of Depression Centers ECT Task Group. ElectroConvulsive therapy Cognitive Assessment (ECCA) tool: A new instrument to monitor cognitive function in patients undergoing ECT. J Affect Disord. 2020 May 15;269:36-42. doi: 10.1016/j.jad.2020.03.010. Epub 2020 Mar 4.

    PMID: 32217341BACKGROUND

Study Officials

  • Melike C Balcı Şengül

    Pamukkale Üniversitesi Psikiyatri HASTANESİ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatry Resident

Study Record Dates

First Submitted

March 13, 2026

First Posted

April 14, 2026

Study Start

July 8, 2025

Primary Completion (Estimated)

July 8, 2026

Study Completion (Estimated)

November 8, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations