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NCT06871124
Early Neuromodulation in Traumatic Brain Injury
NA trial testing transcranial electrical stimulation in Traumatic Brain Injury (TBI) Patients in 60 participants. Currently enrolling.
30 September 2027
Quick facts
| Lead sponsor | University of Cincinnati |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 16 June 2025 |
| Primary completion | 30 September 2027 |
| Estimated completion | 30 November 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- transcranial electrical stimulation
- Sham Comparator
Conditions studied
- Traumatic Brain Injury (TBI) Patients — all drugs for Traumatic Brain Injury (TBI) Patients →
Sponsor
University of Cincinnati
Who can join
Adults 18 to 80, any sex, with Traumatic Brain Injury (TBI) Patients. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06871124
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Other recruiting trials for Traumatic Brain Injury (TBI) Patients
Currently open trials in the same condition.
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- NCT07292766 — Metabolomic Profiling of Patients With Traumatic Brain Injury · recruiting
- NCT02030366 — Chromatic Multifocal Pupillometer for Detection and Follow-up of Acute Head Injury · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06871124 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Cincinnati
- Last refreshed: 29 May 2025
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