At a glance
ClinicalIndex Comparison Record- ✓Age 18-85 years
- ✓Non-military personnel and not veterans
- ✓Traumatic brain injury more than 1 year prior with word-finding difficulty confirmed by neuropsychological testing
- ✓Mild to moderate TBI severity based on Ohio State TBI Identification Method
- ✕Implanted or electronic device (pacemaker, metallic cranial/intracranial implant, neurostimulator)
- ✕Skull defects
- ✕History of psychological or neurological disorder (dementia, epilepsy, seizure disorders, PTSD, brain tumor, stroke, Parkinson's disease, Huntington's disease, or multiple sclerosis)
- ✕Present drug abuse
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Word Finding Difficulties and Verbal Retrieval Deficits in Civilians Who Sustain a Chronic Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation
In Brief
A clinical study evaluating Active Transcranial direct current stimulation and Sham Transcranial direct current stimulation for Traumatic Brain Injury and 3 related conditions. Completed, enrolled 5 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.