Status:
COMPLETED
Transcranial Electrical Stimulation for mTBI
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
San Diego Veterans Healthcare System
Conditions:
Mild Traumatic Brain Injury (mTBI)
Post-traumatic Stress Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
mTBI is a leading cause of sustained physical, cognitive, emotional, and behavioral deficits in OEF/OIF/OND Veterans and the general public. However, the underlying pathophysiology is not completely u...
Detailed Description
Mild traumatic brain injury (mTBI) is a leading cause of sustained physical, cognitive, emotional, and behavioral deficits in OEF/OIF/OND Veterans and the general public. However, the underlying patho...
Eligibility Criteria
Inclusion
- Inclusion of Veterans for the mTBI groups:
- All symptomatic mTBI patients will be evaluated in a clinical interview to document the nature of the injuries and ongoing PCS.
- The diagnosis of mTBI patients is based on standard VA/DOD diagnostic criteria.
- Inclusion in the mTBI patient group requires a TBI that meets the following criteria:
- a loss of consciousness (LOC) \< 30 minutes or transient confusion, disorientation, or impaired consciousness immediately after the trauma
- post-traumatic amnesia (PTA) \< 24 hours
- an initial Glasgow Coma Scale (GCS) \[90\] between 13-15 (if available)
- Since the GCS assessment is often not available in theater, Veterans with missing GCS, but who meet other inclusion criteria will also be recruited.
- Each patient must have at least 3 items of persistent PCS at the beginning of the study.
- Inclusion of Healthy Control (HC) group:
- Veterans that qualify as HCs will be age, education, combat exposure, and socioeconomically matched to the mTBI groups.
- In addition to exclusion criteria listed above, HC subjects must not have been diagnosed with head injury, affective disorder, or PTSD (CAPS-5 \< 8) throughout life.
Exclusion
- Exclusion criteria for study participations include:
- history of other neurological, developmental, or psychiatric disorders (based on the DSM-5 (MINI-7) \[86\] structured interview), e.g.,:
- brain tumor
- stroke
- epilepsy
- Alzheimer's disease
- schizophrenia
- bipolar disorder
- ADHD
- or other chronic neurovascular diseases such as hypertension and diabetes
- substance or alcohol use disorders according to DSM-5 \[87\] criteria within the six months prior to the study
- history of metabolic or other diseases known to affect the central nervous system (see \[88\] for similar criteria)
- Metal objects (e.g., shrapnel or metal fragments) that fail MRI screening, or extensive metal dental hardware, e.g.,:
- braces and large metal dentures
- fillings are acceptable
- other metal objects in the head
- neck, or face areas that cause non-removable artifacts in the MEG data
- Potential subjects will be administered the Beck Depression Inventory (BDI-II) to evaluate level of depressive symptoms, and suicidal ideation
- any participant who reports a "2" or "3" on the BDI-II: item 9 (suicidal thoughts or wishes) will also be excluded.
- However, depression following mTBI or traumatic event of PTSD is common \[89\]: therefore, in two mTBI groups, the investigators will include and match patients with depression symptoms reported after their injury/event, and will co-vary BDI-II score in data analyses.
Key Trial Info
Start Date :
February 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03244475
Start Date
February 1 2017
End Date
September 30 2022
Last Update
January 18 2024
Active Locations (1)
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1
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161