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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

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Post Concussive Symptoms Depression Executive Dysfunction Device: Anodal tDCS Behavioral: Cognitive training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation for the Treatment of Deficits After Traumatic Brain Injury
Study Start Date : September 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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, 40 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.




Primary Outcome Measures :
  1. Change in Examiner Score [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613936


Contacts
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Contact: Darbi Gill 505-925-4043 DMGill@salud.unm.edu

Locations
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United States, New Mexico
UNM Center for Brain Recovery and Repair Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Davin Quinn, MD    505-272-4763    dquinn@salud.unm.edu   
Principal Investigator: Davin Quinn, MD         
Sponsors and Collaborators
University of New Mexico
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: William Shuttleworth, PhD UNM Center for Brain Recovery and Repair

Additional Information:
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Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT02613936     History of Changes
Other Study ID Numbers: UNM HRRC #15-124
1P20GM109089-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual patient data on task performance may be requested from the researchers after study completion.
Keywords provided by University of New Mexico:
traumatic brain injury
post concussive symptoms
depression
executive dysfunction
brain stimulation
Additional relevant MeSH terms:
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Depression
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Injuries
Brain Injuries, Traumatic
Post-Concussion Syndrome
Wounds and Injuries
Behavioral Symptoms
Craniocerebral Trauma
Trauma, Nervous System
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating