Acquired Brain Injury, Cognitive Change, Traumatic Brain Injury, Word Finding Difficulty
Conditions
Keywords
transcranial direct current stimulation, electroencephalography, Cognition
Brief summary
The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., pre-supplementary motor area) thought to aid in memory will improve verbal retrieval in civilian (non-military, non-veteran) participants with histories of traumatic brain injuries. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures. Additionally, the study will examine the degree to which baseline assessments of cognition, concussion history, structural brain imaging, and EEG predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.
Detailed description
Using two treatment arms, the study will examine improvement of verbal retrieval and other cognitive deficits associated with remote traumatic brain injury by comparing (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 10 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and 2-month follow-up testing sessions, participants will be invited back for newly assigned treatment conditions, 20 minutes over 10 sessions and will be re-evaluated at 2-months follow-up testing sessions. Civilians with histories of traumatic brain injuries and observed cognitive deficits will be randomly assigned to one of the two treatment arms (and re-assigned for the second round of intervention, as described above). Primary outcome verbal retrieval measures, secondary neuropsychological and electroencephalography (EEG) measures, and prescreening assessments for study concussion history and contraindications for treatment will be collected prior to being assigned to a treatment arm (i.e., baseline). Magnetic resonance imaging of the brain will be obtained only at the baseline assessment. Primary outcome verbal retrieval measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected after treatment session 10 and one time following treatment competition (i.e., 2-months). For participants who complete the second round of intervention, primary outcome verbal memory measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected again after treatment session 10 and one time following competition of the second treatment (i.e., 2-months). This study was funded by NIH/NIDCD under grant number \[1K99DC020185\]. Federal funding concluded on 11/30/2024.
Interventions
DEVICEActive Transcranial direct current stimulation
Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.
DEVICESham Transcranial direct current stimulation
Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.
Sponsors
The University of Texas at Dallas
National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants, assessors, and technicians interacting with participants will be blind to assigned conditions.
Intervention model description
Participants will be randomly assigned to 1 of 2 treatment arms: (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 10 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and 2-month follow-up testing sessions, all participants will be invited back for newly assigned treatment conditions, 20 minutes over 10 sessions and will be and re-evaluated at 2-months follow-up testing sessions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Controlled Oral Word Association Test | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. | Evaluation of treatment differences (active versus sham) in change on the Control Word Association Test. Metric: Total Number of Correct Items Generated for three different letters. Total Range 0 (minimum) - 200 (maximum). Larger numbers indicate better performance. |
| Category Fluency | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. | Evaluation of treatment differences (active versus sham) in change on Category Fluency. Metric: Total Number of Correct Items Generated for Animal. Total Range 0 (minimum) - 100 (maximum). Larger numbers indicate better performance. |
| The Boston Naming Test | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. | Evaluation of treatment differences (active versus sham) in change on The Boston Naming Test - 30 items. Metric: Total Number of Correct Items Generated. Total Range 0 (minimum) - 30 (maximum). Larger numbers indicate better performance. |
| Semantic Object Retrieval Test | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. | Evaluation of treatment differences (active versus sham) in change in Semantic Object Retrieval Test. Metric: Total Number of Correct Retrievals. Total Range 0 (minimum) - 32 (maximum). Larger numbers indicate better performance. |
| The Delis Kaplan Color Word Interference Test, Naming | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. | Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance. |
| The Delis Kaplan Color Word Interference Test, Reading | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. | Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance. |
| The Delis Kaplan Color Word Interference Test, Inhibition | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. | Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance. |
| The Delis Kaplan Color Word Interference Test, Inhibition and Switching | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. | Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 240 (maximum). Longer time indicates worse performance. |
| Rey Auditory Verbal Learning Test and Alternative Lists, Total Learning | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. | Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Number of Total learning items and Correct Recalls. Total Range 0 (minimum) - 75 (maximum). Larger numbers indicate better performance. |
| Rey Auditory Verbal Learning Test and Alternative Lists, Delayed Recall | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. | Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Total Number of Delayed Recall items and Correct Recalls. Total Range 0 (minimum) - 15 (maximum). Larger numbers indicate better performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Trail Making Test - Part A | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. | Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A\&B). Metric: Time to Solution. Total Range 0 (minimum) - 300 (maximum). Longer time indicates worse performance. |
| The Trail Making Test - Part B | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. | Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A\&B). Metric: Time to Solution. Total Range 0 (minimum) - 300 (maximum). Longer time indicates worse performance. |
| Digit Span Forward | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. | Evaluation of treatment differences (active versus sham) in change in Digit Span Forward. Metric: Memory Span, a composite score of how many numbers are repeated correctly in a forward order. Z = 0 is the normed average, with positive Z values better and negative Z values worse than the normed average. |
| Digit Span Backward | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. | Evaluation of treatment differences (active versus sham) in change in Digit Span Backward. Metric: Memory Span, a composite score of how many numbers are repeated correctly in a backward order. Z = 0 is the normed average, with positive Z values better and negative Z values worse than the normed average. |
| Rey-Osterrieth Complex Figure Test - Delayed Recall | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. | Evaluation of treatment differences (active versus sham) in change in Rey-Osterrieth Complex Figure Test scores. Metric: Score. Total Range 0 (minimum) - 36 (maximum). This is a summed score of the number and accuracy of complex figure features captured. Larger numbers indicate better performance. |
| The Digit Symbol Substitution Test | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. | Evaluation of treatment differences (active versus sham) in change on the Digit Symbol Substitution Test. Metric: Number of Items. Total Range 0 (minimum) - 135 (maximum). Larger numbers indicate better performance. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohn Hart, MD
University of Texas at Dallas
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 15.6 |
| Category Fluency | 18 Total items STANDARD_DEVIATION 1.73 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 2 Participants |
| Rey Auditory Verbal Learning Test and alternative lists, delayed recall | 7.333333333 Total items STANDARD_DEVIATION 5.033222957 |
| Rey Auditory Verbal Learning Test and alternative lists, total learning | 40.66666667 Total items STANDARD_DEVIATION 15.14375559 |
| Semantic Object Retrieval Test | 30.4 Total items STANDARD_DEVIATION 1.52 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
| The Boston Naming Test | 27.2 Total items STANDARD_DEVIATION 1.93 |
| The Controlled Oral Word Association Test | 30.5 items STANDARD_DEVIATION 0.71 |
| The Delis Kaplan Color Word Interference Test, inhibition | 62.8 Time - seconds STANDARD_DEVIATION 9.833615815 |
| The Delis Kaplan Color Word Interference Test, inhibition and switching | 72.8 Time - seconds STANDARD_DEVIATION 16.52876281 |
| The Delis Kaplan Color Word Interference Test, naming | 41 Time- Seconds STANDARD_DEVIATION 7.071067812 |
| The Delis Kaplan Color Word Interference Test, reading | 27.5 Time - seconds STANDARD_DEVIATION 12.02081528 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 0 / 3 | 0 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 |
Outcome results
None listed