Early Neuromodulation in Traumatic Brain Injury (NCT06871124)
Early Neuromodulation for Cognitive Recovery and Rehabilitation in Traumatic Brain Injury
🩺 Plain-English Summary (8th-Grade Level)
The two goals of the proposed study are: (1) To determine how brain activity changes with cognitive recovery over time from acute to chronic phases of traumatic brain injury (TBI). (2) To determine how the time of anodal transcranial electrical stimulation (A-tES) administration affects cognitive performance and brain activity in TBI. To achieve these study goals, the investigators will conduct a pilot clinical trial over three years in which the investigators aim to recruit 60 patients with moderate to severe TBI at the University of Cincinnati Medical Center (UCMC). During the acute phase of TBI, all participants will complete clinical questionnaires and perform 2 cognitive computer tasks while their brain activity is recorded. Half of the participants will be randomly selected to receive A-tES for 15 minutes while performing cognitive tasks and the other half will receive sham stimulation. All participants will be followed for 6 months. During their 3-month follow-up, the investigators will perform another session where all participants complete the questionnaires and receive A-tES while performing cognitive tasks during brain recording. In their last visit at 6 months post-injury, all participants will complete the questionnaires and cognitive tasks with brain recording but no stimulation treatment. From the collected data, the investigators will determine if time from brain injury correlates with brain activity during performance of cognitive tasks. The investigators will also assess the efficacy of early A-tES treatment for improving cognitive task performance and clinical test ratings at 6 months post-injury in comparison to A-tES delivered during the 3-month follow-up visit.
Who can join: Review the eligibility criteria below.
Location: University of Cincinnati — Cincinnati, Ohio
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of Cincinnati — Cincinnati, Ohio
📞 Contact the Study Coordinator
Phone: (513) 558-3991
Email: basuia@ucmail.uc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Traumatic Brain Injury (TBI) Patients
- Transcutaneous Vagus Nerve Stimulation for Attention and Memory — Houston, Texas
- Home-Based Walking for Thinking Skills in Persons With TBI — East Hanover, New Jersey
- SeeMe: Using Automated Facial Tracking to Detect Voluntary Behavior in Brain Injury — Stony Brook, New York
- Effect of Fixation Training With Colored Light Targets on Traumatic Brain Injury-Associated Photophobia — Columbus, Ohio
- Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury — Cleveland, Ohio
Explore by condition: All Traumatic Brain Injury (TBI) Patients clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.