N/A N=108 Randomized Double-blind Treatment

Brain Training to Enhance Frontal Lobe Reasoning

Traumatic Brain Injury

Bottom Line

View on ClinicalTrials.gov: NCT01552473 ↗

Enrolled (actual)

108

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Glasgow Outcome Scale-Extended — 6.21; 6.30 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Brain Training Program 1 (Behavioral); Brain Training Program 2 (Behavioral)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: The University of Texas at Dallas
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Glasgow Outcome Scale-Extended	6.21; 6.30	—
PRIMARY Community Integration Questionnaire	16.91; 18.71	—
PRIMARY Functional Status Exam	24.02; 22.14	—
PRIMARY Daneman-Carpenter Reading Span Test	2.81; 2.89	—
PRIMARY Hayling Sentence Completion Test	5.96; 6.05	—
PRIMARY Awareness Questionnaire	34.94; 38.00	—
SECONDARY Network Based Statistics in Brain Connectivity	0; 14	0.01 sig
SECONDARY Beck Depression Inventory (BDI)	18.28; 18.41	—
SECONDARY Post Traumatic Stress Disorder (PTSD) Checklist	46.76; 44.09	—
SECONDARY Alcohol, Smoking and Substance Involvement Screening Test	19.40; 22.18	—
SECONDARY Alcohol Use Disorders Identification Test	2.94; 3.39	—
SECONDARY Digit Vigilence Test	413.06; 359.20	—
SECONDARY Connor-Davidson Resilience Scale	61.26; 64.38	—
SECONDARY Wechsler Memory Scale	12.96; 12.79	—
SECONDARY Wechsler Abbreviated Scale of Intelligence Vocabulary Scale	61.44; 58.14	—
SECONDARY Wechsler Abbreviated Scale of Intelligence Matrix Reasoning	26.56; 27.64	—
SECONDARY Wechsler Abbreviated Scale of Intelligence Similarities	37.69; 36.96	—
SECONDARY Satisfaction With Life Scale	17.56; 16.54	—

Summary

This study is being done to improve the ability to diagnose and to achieve higher-levels of functional recovery in soldiers and civilians who have suffered either mild Traumatic Brain Injury (TBIs) or moderate-to-severe TBIs at chronic stages of brain recovery (greater than 12 months).

Eligibility Criteria

Inclusion Criteria

19-65 years of age
Sustained a traumatic brain injury at least 6 months previously
Comprehend simple instructions, perform tasks and take part in intervention
Read, speak and comprehend English
Participate in tasks involving motor abilities such as use of at least one arm or hand

Exclusion Criteria

Not proficient in reading, comprehending or speaking English
Pre-existing Cerebral Palsy, Mental Retardation, Autism, Epilepsy, Schizophrenia, or Pervasive Developmental Disorder
Individuals with Psychosis, Active Behavioral Disorder, or uncontrolled epilepsy
Women who are pregnant

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01552473). 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.