NCT06607679

Brief Summary

Electroconvulsive therapy (ECT) is an effective method that has been used for many years in the treatment of psychiatric disorders and is currently administered under general anesthesia. This study evaluated the effect of ECT on intracranial pressure by measuring the optic nerve sheath diameter (ONSD) using ultrasonography. The primary aim was to determine how ONSD values measured during the postictal period change compared to baseline values. Secondary objectives included identifying factors related to the participants and the ECT procedure that affect ONSD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 3, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
Last Updated

February 25, 2025

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

September 19, 2024

Last Update Submit

February 22, 2025

Conditions

Keywords

Intracranial Pressure ChangeHypertensionElectroconvulsive Therapy

Outcome Measures

Primary Outcomes (1)

  • Intracranial Pressure Changes During Electroconvulsive Therapy

    During electroconvulsive therapy, sequential measurements were conducted using ocular ultrasound. These measurements revealed significant changes in intracranial pressure during the post-seizure period compared to baseline values.

    45 MINUTES

Secondary Outcomes (1)

  • Association Between ONSD Measurements And Comorbid Conditions

    45 MINUTES

Study Arms (1)

Patients Receiving ECT

Eligibility Criteria

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

Patients admitted to the Psychiatry Clinic at the Faculty of Medicine, Cukurova University

You may qualify if:

  • years and older
  • ASA 1,2,3
  • Participants with various psychiatric problems requiring ECT

You may not qualify if:

  • Intracranial mass, edema, or bleeding observed on MRI scan
  • previous eye surgery
  • severe cataracts
  • glaucoma
  • optic atrophy
  • other severe sight impairment
  • traumatic brain injury, space-occupying, and inflammatory lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University Faculty of Medicine Hospital

Adana, Sariçam, 01330, Turkey (Türkiye)

Location

Related Publications (10)

  • Chawla N. Anesthesia for Electroconvulsive Therapy. Anesthesiol Clin. 2020 Mar;38(1):183-195. doi: 10.1016/j.anclin.2019.10.007. Epub 2020 Jan 3.

    PMID: 32008651BACKGROUND
  • Singh SK, Bhatia K. Ultrasonographic Optic Nerve Sheath Diameter as a Surrogate Measure of Raised Intracranial Pressure in Severe Pregnancy-induced Hypertension Patients. Anesth Essays Res. 2018 Jan-Mar;12(1):42-46. doi: 10.4103/aer.AER_218_17.

    PMID: 29628552BACKGROUND
  • Derikx RL, van Waarde JA, Verwey B, van der Mast RC. Effects on intracranial pressure of electroconvulsive therapy. J ECT. 2012 Jun;28(2):e23-4. doi: 10.1097/YCT.0b013e31824d9b69.

    PMID: 22622301BACKGROUND
  • Czosnyka M, Pickard JD. Monitoring and interpretation of intracranial pressure. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):813-21. doi: 10.1136/jnnp.2003.033126.

    PMID: 15145991BACKGROUND
  • Bouckaert F, Sienaert P, Obbels J, Dols A, Vandenbulcke M, Stek M, Bolwig T. ECT: its brain enabling effects: a review of electroconvulsive therapy-induced structural brain plasticity. J ECT. 2014 Jun;30(2):143-51. doi: 10.1097/YCT.0000000000000129.

    PMID: 24810772BACKGROUND
  • Andrade C, Bolwig TG. Electroconvulsive therapy, hypertensive surge, blood-brain barrier breach, and amnesia: exploring the evidence for a connection. J ECT. 2014 Jun;30(2):160-4. doi: 10.1097/YCT.0000000000000133.

    PMID: 24800688BACKGROUND
  • Perera TD, Luber B, Nobler MS, Prudic J, Anderson C, Sackeim HA. Seizure expression during electroconvulsive therapy: relationships with clinical outcome and cognitive side effects. Neuropsychopharmacology. 2004 Apr;29(4):813-25. doi: 10.1038/sj.npp.1300377.

    PMID: 14735129BACKGROUND
  • Baghai TC, Moller HJ. Electroconvulsive therapy and its different indications. Dialogues Clin Neurosci. 2008;10(1):105-17. doi: 10.31887/DCNS.2008.10.1/tcbaghai.

    PMID: 18472488BACKGROUND
  • Dubourg J, Javouhey E, Geeraerts T, Messerer M, Kassai B. Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2011 Jul;37(7):1059-68. doi: 10.1007/s00134-011-2224-2. Epub 2011 Apr 20.

    PMID: 21505900BACKGROUND
  • Andrade C, Arumugham SS, Thirthalli J. Adverse Effects of Electroconvulsive Therapy. Psychiatr Clin North Am. 2016 Sep;39(3):513-30. doi: 10.1016/j.psc.2016.04.004. Epub 2016 Jun 25.

    PMID: 27514303BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Demet Laflı Tunay, Associate Professor

    Department of Anesthesiology and Reanimation, Çukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant Anesthesiologist

Study Record Dates

First Submitted

September 19, 2024

First Posted

September 23, 2024

Study Start

June 3, 2022

Primary Completion

November 23, 2022

Study Completion

November 23, 2022

Last Updated

February 25, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

I plan to share all IPD that underlie the results in the publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 1 year after publication with no end date.

Locations