Recruiting

Neuromodulation

Sponsor:

University of Cincinnati

Code:

NCT06871124

Conditions

Traumatic Brain Injury (TBI) Patients

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

transcranial electrical stimulation

Sham Comparator

Study Details

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.

Conditions

Traumatic Brain Injury (TBI) Patients

Study ID

NCT06871124

Start date

Jun 16, 2025

Status verified date

Jun, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

transcranial electrical stimulation

Anodal transcranial electrical stimulation (A-tES) is a widely used and well tolerated non-invasive electrical stimulation paradigm that promotes adaptive neuroplasticity and may prevent or reduce pathological sequela following brain injury. It has been used in a wide variety of neurologic and psychiatric disorders for cognitive and motor rehabilitation.

Sham Comparator

Sham comparator consist of A-tES in the beginning and end of stimulation block but no stimulation during the actual stimulation period.

Primary outcome measure

  • Cognitive Task Behavior [ Time Frame: from enrollment to 6 months after brain injury ]
  • Task evoked EEG oscillatory power [ Time Frame: from enrollment to end of 6 month visit ]

Central Contacts and Locations

Central contacts

Ishita Basu, PhD

5135583991basuia@ucmail.uc.edu

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Ishita Basu

2178199493basuia@ucmail.uc.edu

More Information

Sponsor

University of Cincinnati

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

  • transcranial electrical stimulation
  • cognitive control
  • working memory
  • EEG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2026-06-03.