The University of Minnesota is advancing research into persistent cognitive issues following mild traumatic brain injuries (mTBIs). A new clinical trial, outlined on ClinicalTrials.gov, aims to evaluate the impact of transcranial direct current stimulation (tDCS) devices, both active and sham, on neuroplasticity and recovery for individuals diagnosed with Persistent Post-Concussion Syndrome.
Research Focus
Cognitive and emotional symptoms may persist long after initial rehabilitation in mild traumatic brain injury cases. This trial targets neuroplasticity by testing transcranial direct current stimulation (tDCS), a non-invasive technique that delivers low electrical currents to specific areas of the brain. Researchers hypothesize that stimulating these regions may contribute to recovery and alleviate long-term symptoms commonly associated with Persistent Post-Concussion Syndrome.
What Do We Know About the Devices?
The study utilizes two distinct types of devices: an active tDCS unit and a sham version. Active tDCS devices, designed to administer targeted electrical stimulation, are compared against sham devices to isolate therapeutic effects from placebo responses.
The regulatory design and safety standards ensure that both devices meet compliance for investigational use. Data derived from this comparison may influence future therapies and medical device classifications.
Trial Status
As of November 27, 2025, the study has not yet begun recruiting participants. The trial is sponsored by the University of Minnesota, reinforcing its academic seriousness and contribution to medical advancement.
- Participants will be screened for eligibility based on their clinical history of mTBI and Persistent Post-Concussion Syndrome.
- Clinical outcomes will focus on cognitive performance enhancements and symptom relief scalability.
- Further announcements will provide insights into trial progress and tentative recruitment timelines.
Frequently Asked Questions
- What is Persistent Post-Concussion Syndrome?
It refers to lasting cognitive or emotional problems experienced after a concussion or mild traumatic brain injury. - What is tDCS?
Transcranial Direct Current Stimulation (tDCS) is a device-based technique that applies low-intensity electric currents to the brain to influence brain function and potentially improve recovery. - Who is conducting this trial?
The study is led by researchers from the University of Minnesota. - What is the current trial status?
The study is marked as “Not yet recruiting” as of November 2025.
Key Takeaways
This trial highlights the growing interest in using medical device innovations to treat long-term effects of concussions. Clinical stakeholders and regulatory bodies can monitor updates to assess how findings may influence broader therapeutic protocols.
Disclaimer
This article aims to provide informational updates on medical device-related trials. It is not legal or medical advice. Professionals should rely on official regulatory documents for compliance standards.
Full Announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07246993?term=medical+device