Clinical Trials Logo

Clinical Trial Summary

80 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) (40 active, 40 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.

Clinical Trial Description

Our long-term goal is to develop safe and effective treatments for symptoms of mild to moderate TBI (mmTBI) that restore patients to higher levels of functioning, decrease disability, and promote brain healing. The objective of this application is to investigate the use of transcranial direct current stimulation (tDCS) to treat symptoms of executive dysfunction and depression in patients with mmTBI. Our central hypotheses are (1) tDCS paired with relevant cognitive training facilitates improves executive function on National Institutes of Health (NIH)-approved neuropsychological measures, (2) tDCS reduces depression scores on NIH Common Data Elements for TBI, (3) that these improvements in emotion and cognition will be detectable up to one year after stimulation, and (4) certain clinical variables will reliably predict response to tDCS. These objectives were formulated based on our clinical experience with Dr. Ronald Yeo (project mentor) characterizing symptomatic patients with mmTBI in the post-acute setting and groundbreaking research led by Dr. Vincent Clark (project mentor) that has demonstrated robust increases in attention and learning with tDCS.

Specific Aim 1: tDCS for executive dysfunction in mmTBI Experiments in this aim will test the hypothesis that in patients with mmTBI, left prefrontal anodal tDCS concurrent with cognitive training for ten consecutive weekdays will result in significantly more improvement in executive function compared to sham stimulation. Patients with cognitive complaints 3 months to 2 years after mmTBI will be recruited from local emergency departments and brain injury clinics. Aim 1.1: tDCS will be paired with computer-based cognitive training tasks of response inhibition, set shifting, and working memory, while executive function will be measured with the NIH Examiner battery before, immediately after, and one month after stimulation. Aim 1.2: Persistence of post-traumatic symptom reduction and quality of life improvement will be assessed with Common Data Elements instruments via telephone interview at 6 months and one year. Aim 1.3: Clinical predictors of tDCS response including injury severity, premorbid intelligence, and post-traumatic symptom burden will be determined with linear mixed-models analysis.

Specific Aim 2: tDCS for depressive symptoms in mmTBI Experiments in this aim will test the hypothesis that left prefrontal anodal tDCS in patients with mmTBI will significantly reduce depressive symptoms compared to sham stimulation. Aim 2.1: Patients will be assessed for symptoms of depression via self-report instruments and clinician-administered scales from NIH Common Data Elements before, immediately after, and one month after the stimulation protocol. Aim 2.2: Persistence of antidepressant benefit will be assessed via telephone interview at 6 months and one year. Aim 2.3: clinical predictors of tDCS response such as injury severity, premorbid intelligence, and symptom burden will be determined. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT02613936
Study type Interventional
Source University of New Mexico
Contact Darbi Gill
Phone 505-925-4043
Status Recruiting
Phase N/A
Start date September 2015
Completion date June 2020

See also
  Status Clinical Trial Phase
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran for Depression in Palliative Care Phase 2/Phase 3
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Active, not recruiting NCT03069417 - Support for Perinatal Adherence and Depression N/A
Active, not recruiting NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Enrolling by invitation NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03272555 - WILD 5 Wellness: A 30-Day Intervention N/A
Completed NCT03129204 - Sensation Awareness Focused Training for Spouses N/A
Completed NCT01198197 - PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A Early Phase 1
Active, not recruiting NCT03684434 - Online Cognitive Behaviour Therapy for Depression and Anxiety: Randomized Controlled Trial Varying Treatment Content N/A
Recruiting NCT03749278 - Latina Friends Motivating the Soul (ALMA) N/A
Recruiting NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Recruiting NCT03537053 - An Approach to "Move a Little & Often" With Health Conditions N/A
Recruiting NCT00024635 - Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers
Not yet recruiting NCT03879525 - EMR Outcomes: Anxiety and Depression in Epilepsy N/A
Not yet recruiting NCT03490253 - Diabetes and Depression Text Messaging Intervention N/A
Not yet recruiting NCT03645447 - The Taste-Mood Diagnostic Study N/A
Recruiting NCT02919280 - Dallas 2K: A Natural History Study of Depression
Recruiting NCT02970825 - Move and Feel Good : Effects of Intensive Physical Training on Brain Plasticity, Cognition and Psychological Well-being. N/A