Intracranial Pressure ChangeNCT06607679
Optic Nerve Sheath Ultrasound During Electroconvulsive Therapy
An observational study of Intracranial Pressure Change and Hypertension, run by İrem AKSOY at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pressure Change, Hypertension, Electroconvulsive Therapy Treated Patients
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2022to 23 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Psychiatry Clinic at the Faculty of Medicine, Cukurova University
Who may be able to join
- 18 years and older
- ASA 1,2,3
- Participants with various psychiatric problems requiring ECT
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukurova University Faculty of Medicine Hospital
Adana, Sariçam, 01330
About this study
Official title: Monitoring Intracranial Pressure Change Via Optic Nerve Sheath Ultrasound During Electroconvulsive Therapy
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.
Read the detailed description
Electroconvulsive therapy (ECT) is a treatment method that has been used effectively for many years in the treatment of psychiatric disorders. Typical uses of ECT include depression, schizophrenia, bipolar disorder, cases resistant to standard therapies, individuals at risk of suicide, and patients exhibiting symptoms of catatonia. The safety of ECT remains a highly debated issue. It is commonly believed that ECT should be avoided in cases of tumors or other space-occupying lesions due to concerns that the therapys stimulus or induced seizure could lead to increased intracranial pressure. The American Psychiatric Association Task Force Report recommends a detailed evaluation of the risk-benefit ratio and measures to minimize the risks associated with the treatment. Measurement of the optic nerve sheath diameter (ONSD) with ultrasound is a direct, noninvasive, and rapid technique for assessing raised ICP. Comparisons between ocular sonography and magnetic resonance imaging (MRI) have shown an acceptable correlation and reliability. In this study, the effects of ECT on intracranial pressure were evaluated by measuring the optic nerve sheath diameter (ONSD) using ultrasonography. The primary aim was to determine the change in ONSD value during the postictal period compared to baseline. Secondary objectives include identifying participants and ECT procedure-related factors affecting ONSD.
- Keywords
- Intracranial Pressure Change, Hypertension, Electroconvulsive Therapy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Receiving ECT | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 45 MINUTES
Secondary outcomes (1)
Association Between ONSD Measurements And Comorbid Conditions
An examination of the relationship between increased optic nerve sheath diameter (ONSD) and comorbid conditions revealed that hypertension, higher body mass index, and advanced age were associated with elevated postictal ONSD values.
Measured: 45 MINUTES
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start3 Jun 2022
- Primary completion23 Nov 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Intracranial Pressure ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- İrem AKSOY
- Sponsor type
- University, hospital or other
- Collaborators
- Cukurova University Medical Faculty Hospital
- Responsible party
- Sponsor-investigator, İrem AKSOY, Cukurova University
- Investigators
- Demet Laflı Tunay, Associate Professor, Principal investigator, Department of Anesthesiology and Reanimation, Çukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607679
- Sponsor's protocol ID
- 2022-05-03-123/26
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I plan to share all IPD that underlie the results in the publication.
Publications
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.
PubMed 32008651Singh 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.
PubMed 29628552Derikx 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.
PubMed 22622301Czosnyka 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.
PubMed 15145991Bouckaert 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.
PubMed 24810772Andrade 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.
PubMed 24800688Perera 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.
PubMed 14735129Baghai 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.
PubMed 18472488Dubourg 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.
PubMed 21505900Andrade 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.
PubMed 27514303
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Intracranial Pressure Change Via Optic Nerve Sheath Ultrasound During Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT06607679
- Acronym / sponsor ID
- 2022-05-03-123/26
- Keywords
- Intracranial Pressure Change, Hypertension, Electroconvulsive Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- İrem AKSOYUniversity, hospital or other
- Collaborators
- Cukurova University Medical Faculty Hospital
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Electroconvulsive therapy (ECT) is a treatment method that has been used effectively for many years in the treatment of psychiatric disorders. Typical uses of ECT include depression, schizophrenia, bipolar disorder, cases resistant to standard therapies, individuals at risk of suicide, and patients exhibiting symptoms of catatonia. The safety of ECT remains a highly debated issue. It is commonly believed that ECT should be avoided in cases of tumors or other space-occupying lesions due to concerns that the therapys stimulus or induced seizure could lead to increased intracranial pressure. The American Psychiatric Association Task Force Report recommends a detailed evaluation of the risk-benefit ratio and measures to minimize the risks associated with the treatment. Measurement of the optic nerve sheath diameter (ONSD) with ultrasound is a direct, noninvasive, and rapid technique for assessing raised ICP. Comparisons between ocular sonography and magnetic resonance imaging (MRI) have shown an acceptable correlation and reliability. In this study, the effects of ECT on intracranial pressure were evaluated by measuring the optic nerve sheath diameter (ONSD) using ultrasonography. The primary aim was to determine the change in ONSD value during the postictal period compared to baseline. Secondary objectives include identifying participants and ECT procedure-related factors affecting ONSD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving ECT | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Psychiatry Clinic at the Faculty of Medicine, Cukurova University
Key inclusion criteria (3 listed)
- 18 years and older
- ASA 1,2,3
- Participants with various psychiatric problems requiring ECT
Key exclusion criteria (7 listed)
- Intracranial mass, edema, or bleeding observed on MRI scan
- previous eye surgery
- severe cataracts
- glaucoma
- optic atrophy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intracranial Pressure Changes During Electroconvulsive Therapy
Time frame: 45 MINUTES
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.
1 secondary outcome
Association Between ONSD Measurements And Comorbid Conditions
Time frame: 45 MINUTES
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Results publication: PubMed 32008651Chawla 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.
- Results publication: PubMed 29628552Singh 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.
- Results publication: PubMed 22622301Derikx 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.
- Results publication: PubMed 15145991Czosnyka 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.
- Results publication: PubMed 24810772Bouckaert 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.
- Results publication: PubMed 24800688Andrade 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.
- Results publication: PubMed 14735129Perera 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.
- Results publication: PubMed 18472488Baghai 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.
- Results publication: PubMed 21505900Dubourg 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.
- Results publication: PubMed 27514303Andrade 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.
- Individual participant dataSharing planned: Yes. I plan to share all IPD that underlie the results in the publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Demet Laflı Tunay, Associate Professor principal investigator
Department of Anesthesiology and Reanimation, Çukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure Change and Hypertension, run by İrem AKSOY at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial Pressure Changes During Electroconvulsive Therapy (time frame: 45 MINUTES). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06607679, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.