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Transcranial Direct Current Stimulation (TDCS) as an Intervention for Patients With Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT02849223
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : August 23, 2018
Sponsor:
Collaborators:
State of Minnesota
Minnesota Veterans Medical Research and Education Foundation
Information provided by (Responsible Party):
Tasha Nienow, Minneapolis Veterans Affairs Medical Center

Study Description
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Brief Summary:
The primary aim of this study is to assess the magnitude of transcranial direct current stimulation (tDCS) -induced cognitive and functional change in patients with mild traumatic brain injury. This study will also attempt to identify biomarkers associated with treatment response. Last, acceptability and tolerability of procedures will be assessed. To accomplish these aims, a randomized, double-blind, sham-controlled, parallel groups, pilot study will be conducted in which participants are assigned to 24 sessions of tDCS or sham stimulation offered concurrent with working memory training. Neural efficiency will be measured with electroencephalogram (EEG) pre and post-intervention.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Device: Anodal Transcranial Direct Current Stimulation Device: Sham stimulation Phase 2

Detailed Description:
Transcranial direct current stimulation (tDCS) is a safe, non-invasive neuromodulation technique that shows promise as an intervention technique. The primary aim of this study is to assess the magnitude of tDCS-induced cognitive and functional change in patients with mild traumatic brain injury (TBI). In this double-blind, sham-controlled, pilot study, 24 veterans with mild TBI will be randomized to tDCS or sham conditions. Stimulation will be administered with a StarStim neurostimulator at 2 milliamps (mA) for 20 minutes. The anodal electrode will be placed over the left dorsal lateral prefrontal cortex. Twenty-four sessions of stimulation will be administered concurrent with 20 minutes of working memory training. Participants will continue with an additional 40 minutes of working memory training post-stimulation. Participant experience with neuromodulation will be assessed with a self-report questionnaire that lists common reactions to tDCS. Participant perception of the value of neuromodulation procedures will be assessed at weeks 4 and 8. A second aim is to identify biomarkers of treatment response. Resting state electroencephalogram (EEG) will be collected at three time points: prior to the first tDCS training session, immediately after the first training session, and post-intervention. This study will provide preliminary evidence of the efficacy of providing tDCS as an intervention to enhance cognitive and functional outcomes for individuals with mild traumatic brain injury. Furthermore, the results of this study will also increase the understanding of the mechanisms by which tDCS enhances cognitive performance. This knowledge has the potential to provide insight into the underlying therapeutic process as well as to guide development of the next generation of interventions. In addition, acceptability of the intervention will be monitored to identify potential barriers to administering tDCS in clinical practice.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (TDCS) as an Intervention for Patients With Traumatic Brain Injury
Actual Study Start Date : July 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : July 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Transcranial Direct Current Stimulation
Participants will receive 24 sessions (3 times a week) of anodal transcranial direct current stimulation concurrent with working memory training. Stimulation will be administered at 2 milliamps (mA) for 20 minutes over the left dorsal lateral prefrontal cortex.
 Device: Anodal Transcranial Direct Current Stimulation
2 milliamps (mA) of anodal stimulation will be applied to the left dorsal lateral cortex for 20 minutes concurrent with working memory training.
Sham Comparator: Sham
Participants will receive 24 sessions of working memory training. The experience of transcranial direct current stimulation will be simulated by administering 30 seconds of stimulation at the beginning of the session.
 Device: Sham stimulation
30 seconds of anodal TDCS stimulation will be applied to the left dorsal lateral cortex concurrent with working memory training


Outcome Measures
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Primary Outcome Measures :
  1. Wechsler Adult Intelligence Scale (WAIS)-III Working Memory Index [ Time Frame: Post-Intervention, 9-10 weeks after baseline assessment ]
    Standard score


Secondary Outcome Measures :
  1. University of California Performance Based Skills Assessment [ Time Frame: Post-Intervention, 9-10 weeks after baseline assessment ]
    Total Score


Other Outcome Measures:
  1. Resting state electroencephalogram (EEG) [ Time Frame: Post-Intervention, 8-9 weeks after baseline assessment ]
    Theta amplified oscillatory power


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans enrolled at the Minneapolis Veterans Affairs (VA) Health Care System
  • Age of 18 and 65
  • Sustained a mild traumatic brain injury more than 1 year ago.

Exclusion Criteria:

  • Presence of a psychotic disorder
  • Severely depressed
  • Clinically unstable due to a hospitalization or medication change in the previous 4 weeks
  • Mild substance use disorder in the last month
  • Moderate to Severe substance use disorder in the last six months
  • Behavioral problems that prevent participation in a group intervention
  • Premorbid intellectual ability (IQ) below 70
  • Unable to provide informed consent
  • Have a guardian of person
  • Have another existing neurological condition that impacts cognitive functioning
  • Not fluent enough in English to understand testing procedures
  • Have a medical condition that is incompatible with transcranial direct current stimulation.
Contacts and Locations
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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): NCT02849223


Contacts
Contact: Tasha M Nienow, PhD 612-467-1004 Tasha.Nienow@va.gov
Contact: Kelvin O Lim, MD 612-725-2000 Kelvin.Lim@va.gov

Locations
United States, Minnesota
Minneapolis Veterans Affairs Health Care System Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Tasha M Nienow, PhD    612-467-1004    Tasha.Nienow@va.gov   
Contact: Kelvin O Lim, MD    612-725-2000    Kelvin.Lim@va.gov   
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
State of Minnesota
Minnesota Veterans Medical Research and Education Foundation
Investigators
Principal Investigator: Tasha M Nienow, PhD Minneapolis Veteran Affairs Health Care System
More Information
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Responsible Party: Tasha Nienow, Staff Psychologist, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02849223     History of Changes
Other Study ID Numbers: 4654-A
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

Keywords provided by Tasha Nienow, Minneapolis Veterans Affairs Medical Center:
Mild Traumatic Brain Injury
Transcranial Direct Current Stimulation
Working Memory

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System