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NCT06871124 · ClinicalTrials.gov registry record · NA
Early Neuromodulation in Traumatic Brain Injury
A NA study of Traumatic Brain Injury (TBI) Patients, sponsored by University of Cincinnati.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06871124 is a NA study of Traumatic Brain Injury (TBI) Patients that is actively recruiting participants, run by University of Cincinnati. The registered enrollment target is 60 participants, below the 181-participant average among 4 other Traumatic Brain Injury (TBI) Patients trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06871124, a NA study of Traumatic Brain Injury (TBI) Patients, is actively recruiting participants, sponsored by University of Cincinnati.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE Sham Comparator
- DEVICE transcranial electrical stimulation
Study Locations (1)
Ohio
- University of Cincinnati - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-06-16 |
| Est. Completion | 2027-11-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06871124
The ClinicalTrials.gov registry entry for NCT06871124 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 181-participant average among 4 other Traumatic Brain Injury (TBI) Patients trials with a reported enrollment target (67% lower). The listed sponsor is University of Cincinnati, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Traumatic Brain Injury (TBI) Patients appearing as the primary indexed condition, and to 2 interventions - of which Sham Comparator is the first listed.
NCT06871124 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT06871124 about?
NCT06871124 is a clinical study titled "Early Neuromodulation in Traumatic Brain Injury". 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 pe...
What is the current status of trial NCT06871124?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-06-16. Estimated completion is 2027-11-30.
What conditions does trial NCT06871124 study?
This clinical trial studies the following conditions: Traumatic Brain Injury (TBI) Patients.
What interventions are being tested in trial NCT06871124?
The interventions under investigation include: Sham Comparator (DEVICE), transcranial electrical stimulation (DEVICE).
Who is sponsoring clinical trial NCT06871124?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06871124 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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