Early Neuromodulation for Cognitive Recovery and Rehabilitation in Traumatic Brain Injury

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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,

• age 18-80 years,

• Isolated TBI,

• Intelligible speech and Galveston Orientation and Amnesia Test (GOAT) score \>70 at time of enrollment.

Locations
United States
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Contact Information
Primary
Ishita Basu, PhD
basuia@ucmail.uc.edu
5135583991
Time Frame
Start Date: 2025-06-16
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 60
Treatments
Experimental: Early intervention
Patients assigned to this arm will receive anodal transcranial electrical stimulation (A-tES) within a 1-2 weeks of their injury and another session of tES at a 3 month follow up visit.
Sham_comparator: Sham
Patients assigned to this arm will receive sham transcranial electrical stimulation (tES) within a 1-2 weeks of their injury and another session of tES at a 3 month follow up visit.
Related Therapeutic Areas
Sponsors
Leads: University of Cincinnati

This content was sourced from clinicaltrials.gov