N/A
N=40
Transcranial Direct Current Stimulation for the Treatment of Deficits After Traumatic Brain Injury
Traumatic Brain Injury · Post Concussive Symptoms · Depression · Executive Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT02613936 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Examiner Score — 0.617; 0.907; 0.865; 1.155 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Anodal tDCS (Device); Cognitive training (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of New Mexico
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Examiner Score |
0.617; 0.907; 0.865; 1.155; 1.037; 1.26 | — |
Summary
Patients with mild-moderate traumatic brain injury (TBI) sustained between 3 months and 5 years ago with prolonged postconcussive symptoms will be recruited. On Day 1 of the study they will undergo neuropsychological (NP) testing. They will then undergo 10 days of Left dorsolateral prefrontal (DLPFC) anodal transcranial direct current stimulation (TDCS) (active or sham) combined with cognitive training. On day 10 NP testing will be obtained again. On Day 30, NP testing will be repeated a 3rd time. At 6 months and 1 year, quality of life, depression, and post concussive symptoms will be assessed.
Eligibility Criteria
Inclusion Criteria
- aged 18-55
- TBI with + loss of consciousness (LOC) less than 24 hours
- injured between 3 months and 5 years ago
- Glasgow Coma Score (GCS) between 9 and 15 upon emergency department (ED) admission
- less than 1 week of post-traumatic amnesia (PTA)
- 1 out of 4 cognitive symptoms on the Neurobehavioral Symptom Inventory (NSI)
Exclusion Criteria
- history of neurological disease or seizures
- history of psychosis
- history of recent substance dependence (past 2 years)
- any skull defect
- presence of any implanted electrical device
- recent medical instability (within 3 weeks)
- pregnancy
- appointment of a legal representative.
Data sourced from ClinicalTrials.gov (NCT02613936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.