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N/A N=40 Randomized Quadruple-blind Treatment

Transcranial Direct Current Stimulation for the Treatment of Deficits After Traumatic Brain Injury

Traumatic Brain Injury · Post Concussive Symptoms · Depression · Executive Dysfunction

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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