Early Neuromodulation in Traumatic Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Cincinnati
About 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 does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
transcranial electrical stimulation
DeviceAnodal 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
DeviceSham comparator consist of A-tES in the beginning and end of stimulation block but no stimulation during the actual stimulation period.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Early interventionExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cognitive Task Behavior
Response time and accuracy on multi source interference task and 1-back working memory task.
Time frame
from enrollment to 6 months after brain injury2
Task evoked EEG oscillatory power
Task evoked theta and alpha band power
Time frame
from enrollment to end of 6 month visitSecondary outcomes
1
Brief Test of Adult Cognition by Telephone (BTACT)
The Brief Test of Adult Cognition by Telephone (BTACT) assesses multiple dimensions central for effective functioning across adulthood: episodic memory, working memory, reasoning, verbal fluency, and executive function. The BTACT is the first instrument which includes measures of processing speed, reaction time, and task switching/inhibitory control for use over the telephone.
Time frame
from enrollment to 6 months after brain injury2
Quality of Life (QOL)
We will formulate a QOL by partnering with a community advisory board comprising of TBI survivors and their caregiver/family members.
Time frame
from enrollment to 6 months after brain injurySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov