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Trial record 56 of 1597 for:    veterans affairs medical center

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

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ClinicalTrials.gov Identifier: NCT02849223
Recruitment Status : Active, not recruiting
First Posted : July 29, 2016
Last Update Posted : August 29, 2019
Sponsor:
Collaborators:
State of Minnesota
Minnesota Veterans Medical Research and Education Foundation
Information provided by (Responsible Party):
Tasha Nienow, Minneapolis Veterans Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE July 24, 2016
First Posted Date  ICMJE July 29, 2016
Last Update Posted Date August 29, 2019
Actual Study Start Date  ICMJE July 2016
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
Wechsler Adult Intelligence Scale (WAIS)-III Working Memory Index [ Time Frame: Post-Intervention, 9-10 weeks after baseline assessment ]
Standard score
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02849223 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
University of California Performance Based Skills Assessment [ Time Frame: Post-Intervention, 9-10 weeks after baseline assessment ]
Total Score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 28, 2016)
Resting state electroencephalogram (EEG) [ Time Frame: Post-Intervention, 8-9 weeks after baseline assessment ]
Theta amplified oscillatory power
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Transcranial Direct Current Stimulation (TDCS) as an Intervention for Patients With Traumatic Brain Injury
Official Title  ICMJE Transcranial Direct Current Stimulation (TDCS) as an Intervention for Patients With Traumatic Brain Injury
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • 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.
  • Device: Sham stimulation
    30 seconds of anodal TDCS stimulation will be applied to the left dorsal lateral cortex concurrent with working memory training
Study Arms  ICMJE
  • 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.
    Intervention: Device: Anodal Transcranial Direct Current Stimulation
  • 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.
    Intervention: Device: Sham stimulation
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 28, 2019)
41
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2016)
32
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02849223
Other Study ID Numbers  ICMJE 4654-A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tasha Nienow, Minneapolis Veterans Affairs Medical Center
Study Sponsor  ICMJE Minneapolis Veterans Affairs Medical Center
Collaborators  ICMJE
  • State of Minnesota
  • Minnesota Veterans Medical Research and Education Foundation
Investigators  ICMJE
Principal Investigator: Tasha M Nienow, PhD Minneapolis Veteran Affairs Health Care System
PRS Account Minneapolis Veterans Affairs Medical Center
Verification Date August 2019

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