The upcoming clinical trial focusing on advanced device-based addiction treatment has gained attention among medical and regulatory professionals. With Indiana University and the National Institute on Drug Abuse (NIDA) as sponsors, this study intends to investigate Temporal Interference non-invasive deep brain stimulation (TI-NDBS) devices for nicotine and substance use disorders. As of October 2025, the trial is listed as “Not yet recruiting,” signaling developments underway in the assessment of novel medical technologies.
In this article:
- What changed?
- What are the study details?
- What are the potential impacts?
- FAQ
- Conclusion
- Disclaimer
- Announcement Link
What changed?
The trial represents a new initiative aimed at targeting addiction at the neurological level using non-invasive medical devices. TI-NDBS, a pioneering technology, employs temporal interference to modulate brain activity without implants. Its assessment in this controlled setting may introduce exciting therapeutic possibilities for patients with nicotine use disorder and broader substance use disorders.
What are the study details?
Who is conducting the study?
Indiana University leads the effort, with support from NIDA. Their collaboration underscores the importance of research in substance use interventions, as addiction continues to pose significant social and health challenges globally.
What are the interventions?
Two devices form the backbone of the trial:
- TI-NDBS Device: Leveraging temporal interference principles for non-invasive brain stimulation.
- Sham TI-NDBS Device: A placebo counterpart to ensure rigorous scientific standards.
What current status is listed?
As of October 2025, recruitment has not commenced. Researchers and stakeholders monitoring the trial await further updates regarding enrollment and operational milestones.
What are the potential impacts?
Why is this important?
Addiction treatment often relies on behavioral therapies or pharmacological solutions. Introducing device-based modalities could revolutionize approaches targeting brain function directly, offering a potential alternative for patients unresponsive to existing interventions.
What challenges could arise?
As with any medical device, questions surrounding safety, efficacy, and long-term effects of TI-NDBS will be pivotal. Regulators and clinicians will closely examine study outcomes to determine whether these devices can comply with medical device directives and safety standards.
FAQ
- Does this trial target only nicotine addiction?
No, it addresses both nicotine use disorder and broader substance use disorders. - Who sponsors the trial?
Indiana University and the National Institute on Drug Abuse (NIDA). - Is this an invasive procedure?
No, TI-NDBS is designed as a non-invasive technology. - What devices will be studied?
Two devices: TI-NDBS and Sham TI-NDBS.
Conclusion
The launch of this trial highlights the pursuit of innovative medical device solutions in addiction treatment. Teams from clinical, regulatory, and quality domains should monitor developments closely as TI-NDBS technology undergoes evaluation. Successful trials could lead to paradigm shifts in how addiction is managed.
Disclaimer
This content is for informational purposes and is not legal advice. Consult appropriate regulatory professionals for compliance with MDR, FDA, or other directives.
Announcement Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07210268?term=medical+device