As of February 19 2026 a not yet recruiting transcranial direct current stimulation trial in higher education targets stress and burnout with a sham control to assess performance and safety.
The entry on ClinicalTrials.gov lists occupational stress or workplace stress and burnout syndrome as conditions of interest. It names a device based intervention using transcranial direct current stimulation and a sham arm as comparators. The sponsor is Egas Moniz – Cooperativa de Ensino Superior, CRL. The record indicates the study is not yet recruiting, signaling early stage planning and regulatory preparation before any participant enrollment.
What changed for this study?
The listing confirms two core conditions and a device oriented intervention. The trial is designed to compare transcranial direct current stimulation against a sham condition to evaluate potential signals for reducing stress related symptoms in a higher education setting. No enrollment information is provided beyond the Not yet recruiting status.
What device and comparator are described?
The intervention is listed as transcranial direct current stimulation. A sham transcranial direct current stimulation arm is described to serve as the control. This implies a randomized approach in which participant blinding may be pursued to separate device effects from placebo effects.
Who is conducting the study and what are the aims?
The sponsor is Egas Moniz – Cooperativa de Ensino Superior, CRL, a higher education organization. The ClinicalTrials.gov record does not reveal participant numbers, endpoints, or interim analyses. The Not yet recruiting status suggests that regulatory steps, site readiness, and ethics approvals are in progress before any subjects are screened.
What is the scope of the investigation?
The study targets occupational stress or workplace stress and burnout in a higher education environment. The use of a sham control supports a rigorous assessment of device related effects separate from expectancy. The information is limited to the listing and does not include clinical outcomes or safety data.
What are the interventions and how is safety addressed?
The intervention uses a medical device approach with tDCS. The inclusion of a sham arm helps blind participants and investigators to treatment allocation, supporting robust interpretation of any observed effects once enrollment begins. The current record does not provide safety data or details about monitoring, stopping rules, or adverse event reporting.
What is transcranial direct current stimulation and why use a sham?
Transcranial direct current stimulation applies low level electrical current to target brain regions. The sham arm mimics the experience without delivering therapeutic current. This design is intended to separate true device effects from placebo responses in a preliminary evaluation.
What is the regulatory framing and next steps?
From a regulatory perspective the trial documents basic device oriented design and the intended population. The Not yet recruiting status indicates that no participants are currently enrolled and that regulatory submissions and ethics review are in progress or pending. Sponsors will need to confirm compliance with local rules for medical devices and clinical research before any participant contact occurs. Transparency through ClinicalTrials.gov supports oversight by stakeholders and potential researchers in higher education settings.
FAQ
- 1. What conditions are listed for this trial?
The entry lists occupational or workplace stress and burnout as the relevant conditions. - 2. What interventions are described?
The interventions are transcranial direct current stimulation and a sham version of the same device. - 3. Who is funding the study?
The sponsor is Egas Moniz – Cooperativa de Ensino Superior, CRL. - 4. What is the enrollment status?
The record shows Not yet recruiting with no enrollment at this time. - 5. Where can I find more information?
The ClinicalTrials.gov page provides primary details and the public record link.
Conclusion
The listing outlines a device based mental health related trial in a higher education context with a sham control. While not yet recruiting, the study sets the framework for how regulatory oversight will approach device safety and performance in a population that faces significant work related stress. Stakeholders should monitor the ClinicalTrials.gov entry for updates on enrollment status, endpoints, and safety findings once they become available.
Disclaimer
This article is intended for professionals and does not constitute legal or medical advice. It reflects a regulatory minded interpretation of the posted trial record and is not a substitute for official regulatory guidance.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07411833?term=medical+device