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

October 4, 2023 updated by: University of New Mexico
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • UNM Center for Brain Recovery and Repair

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Anodal tDCS
Anodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli.
Behavioral: Cognitive training
Cognitive training involves solving executive function tasks on a computer.
Sham Comparator: 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.
Behavioral: Cognitive training
Cognitive training involves solving executive function tasks on a computer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examiner Score
Time Frame: 1 month
The NIH Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER) assesses executive function in four different domains, creating a composite score from all domains, ranging from -3.0 to 2.0 with higher scores indicating better outcome.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Collaborators

National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)

Investigators

  • Principal Investigator: William Shuttleworth, PhD, UNM Center for Brain Recovery and Repair

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

November 23, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimated)

November 25, 2015

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNM HRRC #15-124
  • 1P20GM109089-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual patient data on task performance may be requested from the researchers after study completion.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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