Early Neuromodulation in Traumatic Brain Injury

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT06871124
Status
Recruiting
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Conditions

  • Traumatic Brain Injury (TBI) Patients

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 16, 2025
Status verified
Jun 2026
Primary completion
Nov 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Cognitive Task Behavior [ Time Frame: from enrollment to 6 months after brain injury ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45219
Ishita Basu
[email protected]
2178199493

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By research site
University of Cincinnati· Cincinnati, OH

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