Status:
COMPLETED
High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury
Lead Sponsor:
University of New Mexico
Collaborating Sponsors:
Biomedical Research Institute of New Mexico
New Jersey Institute of Technology
Conditions:
Mild Traumatic Brain Injury
Eligibility:
All Genders
18-59 years
Phase:
NA
Brief 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 demonstra...
Detailed Description
Experimental Design and Methods Participants: 120 subjects will be recruited for this study from the NM VA Health Care System and community, 40 healthy controls subjects for an imaging-only group, and...
Eligibility Criteria
Inclusion
- 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.
- The imaging-only group will have the same inclusion and exclusion criteria except they will not have had a head injury.
Exclusion
- 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;
- 10\) any significant blindness, to screen out peripheral sensory damage; 11) any significant deafness beyond mild hearing loss, to screen out peripheral sensory damage; 12) any ongoing litigation related to TBI, to prevent interference with legal proceedings; 13) any contraindication to MRI; 14) membership in an identified vulnerable population, including minors, pregnant women, and prisoners, so as to prevent coercion.
Key Trial Info
Start Date :
July 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2023
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT03799458
Start Date
July 11 2018
End Date
November 15 2023
Last Update
April 8 2025
Active Locations (1)
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1
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87106