Transcranial Electrical Stimulation for Traumatic Brain Injury

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Cincinnati

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for individuals aged 18-80 who have experienced a moderate to severe traumatic brain injury, as indicated by specific scores on the Glasgow Coma Scale and other criteria. They must be able to speak clearly and show certain levels of orientation and memory function at enrollment.

Inclusion Criteria

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

I have had a traumatic brain injury.

I had a severe head injury with significant consciousness loss or memory issues.

+1 more

Exclusion Criteria

Pregnancy

Patients with polytrauma

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

+3 more

Participant Groups

The study tests how anodal transcranial electrical stimulation (A-tES) affects cognitive performance in TBI patients. Participants are split into two groups: one receives A-tES while doing cognitive tasks, the other gets sham stimulation. Their brain activity is monitored over six months.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Early interventionExperimental Treatment1 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.

Group II: ShamPlacebo Group1 Intervention

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.