Early Neuromodulation in Traumatic Brain Injury

NCT06871124 | Recruiting

• 1 other identifier: TP230311
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

transcranial electrical stimulation; cognitive control; working memory; EEG

Outcome Measures

Primary Outcomes (2)

• Cognitive Task Behavior

  Response time and accuracy on multi source interference task and 1-back working memory task.

  from enrollment to 6 months after brain injury

• Task evoked EEG oscillatory power

  Task evoked theta and alpha band power

  from enrollment to end of 6 month visit

Secondary Outcomes (2)

• Brief Test of Adult Cognition by Telephone (BTACT)

  from enrollment to 6 months after brain injury

• Quality of Life (QOL)

  from enrollment to 6 months after brain injury

Study Arms (2)

Early intervention

EXPERIMENTAL

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.

Device: transcranial electrical stimulation

Sham

SHAM COMPARATOR

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.

Device: Sham Comparator

Interventions

transcranial electrical stimulation DEVICE

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.

Early intervention

Sham Comparator DEVICE

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

Sham

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Persistent bilateral non-reactive pupils or other evidence of non-survivable injury,
• 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.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Ishita Basu, PhD

CONTACT

5135583991; basuia@ucmail.uc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 11, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-06

Locations

US (1)