NCT06871124 Early Neuromodulation in Traumatic Brain Injury
| NCT ID | NCT06871124 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Cincinnati |
| Condition | Traumatic Brain Injury (TBI) Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-06-16 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-06-16 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Moderate to severe TBI: Glasgow Coma Scale (GSC) in the 3-12 range and greater than 30 min of loss of consciousness and/or a post-traumatic amnesia that lasts more than 24 hours and/or an alteration of mental state over 24 hours, 2. age 18-80 years, 3. Isolated TBI, 4. Intelligible speech and Galveston Orientation and Amnesia Test (GOAT) score \>70 at time of enrollment. Exclusion Criteria: 1. Persistent bilateral non-reactive pupils or other evidence of non-survivable injury, 2. Decompressive craniectomy to treat refractory ICP subsequent to diffuse injury, (3) Co-enrollment in another therapeutic TBI trial, (4) Pregnancy, (5) Patients with polytrauma (6) Patients with clinical seizures or status epilepticus.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06871124 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Traumatic Brain Injury (TBI) Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06871124 currently recruiting?
Yes, NCT06871124 is actively recruiting participants. Contact the research team at basuia@ucmail.uc.edu for enrollment information.
Where is the NCT06871124 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT06871124 clinical trial?
NCT06871124 is sponsored by University of Cincinnati. The trial plans to enroll 60 participants.