Treatment with oxygen of headaches after electroshock therapy

Treatment of headaches post-ECT with oxygen therapy; a proof of concept study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001763-23-NL

Enrollment

Registered

2018-06-06

Start date

2018-06-27

Completion date

Unknown

Last updated

2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headaches occuring after electro conculsion therapy.

Interventions

Trade Name: Zuurstof medicinaal vloeibaar AIR LIQUIDE, medicinaal gas, cryogeen 100% v/v Pharmaceutical Form: Inhalation solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age older than 18 Indication for ECT for psychiatric illness. Hospitalized in the department ZPO of the Reinier van Arkel groep Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34

Exclusion criteria

Exclusion criteria: COPD Current use of bleomycine, or in the past 12 months Patients with a custody measure Patients who are mentally incompetent regarding the decision of participation in the study, or undergo trial operations Patients who suffer from panic attacks Patients with a VRS-score equal or less than 1 after ECT Patients with a VRS-score more than 1 before ECT

Design outcomes

Primary

Measure	Time frame
Main Objective: Reduction of headache complaints after electro convulsion therapy. Effect of treatment is defined as a reduction of headache on the VRS (verbal rating scale), from 2 or 3 to equal or less than 1. ;Secondary Objective: Time untill the treatment effect. It is expected that oxygen therapy will result in an imediate reduction of headache, as it is the case in treatment of cluster headache. Duration of treatment effect. It is expected that reduction of headache will last for at least 2 hours. ;Primary end point(s): Reduction of headache from a score of 2 or 3 on the verbal rating scale (VRS) to equal or less than 1.. ;Timepoint(s) of evaluation of this end point: Treatment effect will be measured after ECT, after oxygen therapy and after 60 and 120 minutes after oxygen therapy.	—

Measure

Time frame

Main Objective: Reduction of headache complaints after electro convulsion therapy. Effect of treatment is defined as a reduction of headache on the VRS (verbal rating scale), from 2 or 3 to equal or less than 1. ;Secondary Objective: Time untill the treatment effect. It is expected that oxygen therapy will result in an imediate reduction of headache, as it is the case in treatment of cluster headache. Duration of treatment effect. It is expected that reduction of headache will last for at least 2 hours. ;Primary end point(s): Reduction of headache from a score of 2 or 3 on the verbal rating scale (VRS) to equal or less than 1.. ;Timepoint(s) of evaluation of this end point: Treatment effect will be measured after ECT, after oxygen therapy and after 60 and 120 minutes after oxygen therapy.

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Netherlands

Contacts

Public ContactGijs Hendriks

Reinier van Arkel

gtjmhendriks@gmail.com0031646150456

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026