Treating Civilian Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation (ciTBI-HDtDCS)
Traumatic Brain Injury · Word Finding Difficulty · Acquired Brain Injury · Cognitive Change
Bottom Line
View on ClinicalTrials.gov: NCT05408975 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Transcranial direct current stimulation (Device); Sham Transcranial direct current stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas at Dallas
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Controlled Oral Word Association Test |
30.67; 30.5; 33.33; 35; 34.67; 39.5 | — |
| PRIMARY Category Fluency |
18; 17; 17.67; 24.5; 20; 22.5 | — |
| PRIMARY The Boston Naming Test |
26.67; 28; 27; 29.5; 27.33; 28.5 | — |
| PRIMARY Semantic Object Retrieval Test |
30.33; 30.5; 31.33; 31.5; 30.67; 31 | — |
| PRIMARY The Delis Kaplan Color Word Interference Test, Naming |
35.66666667; 41; 32.66666667; 31; 31.66666667; 34.5 | — |
| PRIMARY The Delis Kaplan Color Word Interference Test, Reading |
26; 27.5; 24; 24; 25.66666667; 25.5 | — |
| PRIMARY The Delis Kaplan Color Word Interference Test, Inhibition |
57; 71.5; 46; 64; 53; 58.5 | — |
| PRIMARY The Delis Kaplan Color Word Interference Test, Inhibition and Switching |
71.33333333; 75; 72; 58; 75.33333333; 56.5 | — |
| PRIMARY Rey Auditory Verbal Learning Test and Alternative Lists, Total Learning |
40.66666667; 48.5; 39.33333333; 57; 43.66666667; 58 | — |
| PRIMARY Rey Auditory Verbal Learning Test and Alternative Lists, Delayed Recall |
7.333333333; 9.5; 6; 12; 8.666666667; 13.5 | — |
| SECONDARY The Trail Making Test - Part A |
37.66666667; 41.5; 27.66666667; 26.5; 28; 27 | — |
| SECONDARY The Trail Making Test - Part B |
68.66666667; 101; 63.66666667; 52.5; 57.66666667; 63.5 | — |
| SECONDARY Digit Span Forward |
0.933333333; 0.4; 0.3; -0.085; -0.34; -0.1 | — |
| SECONDARY Digit Span Backward |
0.2; 0.7; -0.933333333; 1.525; 0.44; 0.25 | — |
| SECONDARY Rey-Osterrieth Complex Figure Test - Delayed Recall |
15.16666667; 25.5; 18.5; 28; 18; 32.5 | — |
| SECONDARY The Digit Symbol Substitution Test |
45; 45.5; 45.33333333; 58; 47.66666667; 58.5 | — |
Summary
Eligibility Criteria
Inclusion Criteria: Participants are to be between the ages of 18-85, are non-military personnel and not veterans, and have had a traumatic brain injury (more than a year ago prior to study participation) that has led to a complaint of word finding difficulty since the brain injury, confirmed to represent a verbal retrieval deficit based on neuropsychological testing criteria. Traumatic brain injury must be in the mild to moderate range based on evaluation, including the Ohio State TBI Identification Method (administered by our research group). You must be fluent in speaking and reading English.
Exclusion Criteria
- an implanted/electronic device, such as a pacemaker, metallic cranial or intracranial implant (e.g., ventriculoperitoneal shunt), or a neurostimulator (e.g., vagus nerve stimulator, spinal stimulator, deep brain stimulator, etc.).
- skull defects
- a history of a psychological or neurological disorder, including, dementia of any type, epilepsy or other seizure disorders, post-traumatic stress disorder, brain tumor, present drug abuse, stroke, blood vessel abnormalities in the brain, Parkinson's disease, Huntington's disease, or multiple sclerosis.
- inability to give informed consent
- currently pregnant
- not a native English speaker
Data sourced from ClinicalTrials.gov (NCT05408975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.