A new clinical trial is setting out to evaluate the effectiveness and safety of transcranial alternating current stimulation (tACS) in treating adolescents with major depressive disorder. Sponsored by the First Affiliated Hospital of Chongqing Medical University, this study offers a unique approach by combining tACS with stable antidepressant medication.
Starting in late 2025, this trial, as registered on ClinicalTrials.gov, has not yet begun recruiting participants. This is significant news for clinical and regulatory teams tracking device-based interventions for depression treatment in younger populations.
Study Background
The clinical trial titled “Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) Combined With Stable Medication in Adolescents With Depression” aims to explore whether tACS can effectively manage depression symptoms when paired with consistent medication regimens. The trial adopts a randomized, double-blind, controlled pilot study design to ensure robust scientific data collection and analysis.
tACS is a non-invasive device that induces oscillatory electrical currents in the brain. Research has suggested that these currents can modulate neuronal activity and improve mood regulation. This trial focuses on adolescents aged 12–18, a demographic often underrepresented in mental health device studies.
How Does tACS Work?
Transcranial alternating current stimulation works by delivering low-intensity electrical currents through electrodes placed on the scalp. These currents aim to interact with brain wave oscillations, potentially adjusting neuronal activity linked to depressive symptoms. Neuroscientists and research teams are particularly interested in tACS’ capacity to target specific frequency bands within the brain.
Unlike invasive procedures such as deep brain stimulation, tACS is designed as a safe alternative that does not require surgery. Manufacturers emphasize safety features and customizable settings to minimize discomfort during use. Regulatory evaluations will likely focus on device performance and adherence to MDR Annex I specifications for safety.
Who Is Eligible?
The trial will recruit adolescents diagnosed with major depressive disorder who are undergoing stable antidepressant treatment. Inclusion criteria will prioritize individuals within the 12–18 age range, ensuring that the device’s performance and safety are specifically assessed for younger users.
Participants and their legal guardians must consent to enrollment, adhering to ethical standards for clinical trials involving minors. Exclusion criteria may involve those with neurological disorders, uncontrolled medical conditions, or sensitivities to electrical stimulation devices.
What Are the Potential Impacts?
This study could pave the way for advancements in device-assisted mental health treatments aimed at adolescents. If successful, the combined-use approach may expand therapeutic options for young individuals who struggle with major depressive disorder and whose symptoms persist despite medication alone.
Moreover, the trial outcomes could influence healthcare decision-making and regulatory approval processes for similar device therapies. The development and validation of tACS as a depression treatment could drive further innovation in non-invasive device technologies.
FAQs
1. What is the primary objective of the study?
The trial aims to assess the efficacy and safety of tACS combined with stable medication in treating adolescents diagnosed with major depressive disorder.
2. How is the study designed?
The study is randomized, double-blind, and controlled, meaning neither participants nor researchers will know who is receiving actual tACS versus a placebo treatment until the trial concludes.
3. When is recruitment expected to begin?
Recruitment has not yet started but is projected to commence late in 2025.
4. Has tACS been tested on adults?
Yes, tACS has been used in various studies involving adults, though this trial specifically focuses on adolescents.
Conclusion
This innovative study highlights the emergence of device-based solutions in adolescent mental health care. Clinical and regulatory professionals should monitor the progress of the trial closely to understand its implications for depression treatment and device approval processes.
Disclaimer
The information provided here is strictly educational and is not intended as legal or professional advice. Consult regulatory guidelines and clinical protocols for detailed requirements.
Study Information Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07185451?term=medical+device