High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex… (NCT03799458) | Clinical Trial Compass
CompletedNot Applicable
High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury
United States79 participantsStarted 2018-07-11
Plain-language summary
Aim 1: To use magnetoencephalography (MEG) and magnetic resonance imaging (MRI) in Veterans and civilians with mild traumatic brain injury (mTBI) and sensory postconcussive symptoms (PCS) to demonstrate the mechanism of therapeutic benefit of HD-tDCS for sensory symptoms, as shown by reliable changes in the activity of the cognitive control network (CCN) and sensory system network (SSN) following stimulation; Aim 2: this intervention will result in long-term improvements in measures of executive function, depression/anxiety, and quality of life.
Who can participate
Age range18 Years – 59 Years
SexALL
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Inclusion criteria
✓. are US Veteran or Active Duty Military personnel aged 18-59,
✓. have suffered a mild TBI (alteration in neurological functioning \< 24 hours, loss of consciousness (LOC) less than 30 minutes, Glasgow coma scale (GCS) score (if available) of between 13 and 15 acutely, and less than 24 hours of post-traumatic amnesia (PTA));
✓. were injured between 3 months and 15 years ago;
✓. have post-traumatic sensory symptoms as evidenced by endorsing at least 2 out of 12 sensory symptoms on the Neurobehavioral Symptom Inventory (NSI), a measure of post-traumatic symptoms from the NIH Common Data Elements (CDE) to a severity of "3" or higher,
✓. are fluent in English,
✓. have been on stable doses of any psychotropic medications for the past 2 months.
Exclusion criteria
✕. any history of moderate or severe TBI;
✕. a prior history of other neurological disease or any history of seizures beyond immediate post-traumatic seizure, to as to reduce risk of exacerbation of epilepsy or other neurological symptoms;
✕. history of psychosis, so as to reduce risk of psychiatric decompensation;
✕. history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on cognition and plasticity;
✕. any discontinuity in skull electrical conductivity (i.e., unhealed burr holes in scalp) or artificially constructed (metal or plastic) craniotomy cover, to reduce risk of unimpeded electrical current;
✕. presence of any implanted electrical device (e.g. pacemaker), to reduce risk of device malfunction;
✕. recent medical hospitalization (within three weeks), to reduce risk of medical decompensation during the study;
✕. any condition that would prevent the subject from completing the protocol; 9) appointment of a legal representative, as assessed via direct inquiry of the subject and a designated trusted other, to avoid coercion of a vulnerable population;