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

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ClinicalTrials.gov Identifier: NCT02613936
Recruitment Status : Recruiting
First Posted : November 25, 2015
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
University of New Mexico

Tracking Information
First Submitted Date  ICMJE November 23, 2015
First Posted Date  ICMJE November 25, 2015
Last Update Posted Date May 8, 2018
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
Change in Examiner Score [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2015)
  • Change in Examiner Score [ Time Frame: 2 weeks ]
  • Change Beck Depression Inventory Score [ Time Frame: 2 weeks ]
  • Change in PROMIS Quality of Life Survey Score [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT02613936 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Direct Current Stimulation for the Treatment of Deficits After Traumatic Brain Injury
Official Title  ICMJE Transcranial Direct Current Stimulation for the Treatment of Deficits After Traumatic Brain Injury
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Traumatic Brain Injury
  • Post Concussive Symptoms
  • Depression
  • Executive Dysfunction
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Active anodal tDCS + cognitive training
    In this arm, 40 patients with mmTBI will undergo 10 sessions of active tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays.
    Interventions:
    • Device: Anodal tDCS
    • Behavioral: Cognitive training
  • Sham Comparator: Placebo anodal tDCS + cognitive training
    In this arm, 40 patients with mmTBI will undergo 10 sessions of placebo tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays.
    Intervention: Behavioral: Cognitive training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 23, 2015)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Darbi Gill 505-925-4043 DMGill@salud.unm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02613936
Other Study ID Numbers  ICMJE UNM HRRC #15-124
1P20GM109089-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual patient data on task performance may be requested from the researchers after study completion.
Responsible Party University of New Mexico
Study Sponsor  ICMJE University of New Mexico
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute of General Medical Sciences (NIGMS)
Investigators  ICMJE
Principal Investigator: William Shuttleworth, PhD UNM Center for Brain Recovery and Repair
PRS Account University of New Mexico
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP