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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2022-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

tDCS as Adjunctive Therapy to Cognitive Stimulation in Medical Students With Depression

NCT06562387

Clinical Trial

ACTIVE_NOT_RECRUITING NA

Transcranial Direct Current Stimulation in Major Depression

NCT03556124

Major Depressive Disorder

COMPLETED NA

Transcranial Direct Current Stimulation (tDCS) Therapy in Major Depression

NCT04507243

Major Depressive Disorder

COMPLETED NA

Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness

NCT01673126

Vegetative State Minimally Conscious State Disorders of Consciousness

COMPLETED PHASE2

High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury

NCT03799458

Mild Traumatic Brain Injury

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury Post Concussive Symptoms Depression Executive Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active anodal tDCS + cognitive training

In this arm, patients with mmTBI will undergo 10 sessions of active tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays.

Group Type EXPERIMENTAL

Anodal tDCS

Intervention Type DEVICE

Anodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli.

Cognitive training

Intervention Type BEHAVIORAL

Cognitive training involves solving executive function tasks on a computer.

Placebo anodal tDCS + cognitive training

In this arm, patients with mmTBI will undergo 10 sessions of placebo tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays.

Group Type SHAM_COMPARATOR

Cognitive training

Intervention Type BEHAVIORAL

Cognitive training involves solving executive function tasks on a computer.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anodal tDCS

Anodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli.

Intervention Type DEVICE

Cognitive training

Cognitive training involves solving executive function tasks on a computer.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. aged 18-55
2. TBI with + loss of consciousness (LOC) less than 24 hours
3. injured between 3 months and 5 years ago
4. Glasgow Coma Score (GCS) between 9 and 15 upon emergency department (ED) admission
5. less than 1 week of post-traumatic amnesia (PTA)
6. 1 out of 4 cognitive symptoms on the Neurobehavioral Symptom Inventory (NSI)

Exclusion Criteria

1. history of neurological disease or seizures
2. history of psychosis
3. history of recent substance dependence (past 2 years)
4. any skull defect
5. presence of any implanted electrical device
6. recent medical instability (within 3 weeks)
7. pregnancy
8. appointment of a legal representative.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No