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

• ClinicalTrials.gov Identifier: NCT02849223
• Recruitment Status: Active, not recruiting
• First Posted: July 29, 2016
• Last Update Posted: August 29, 2019
• Sponsor: Minneapolis Veterans Affairs Medical Center
• 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: July 24, 2016
• First Posted Date: July 29, 2016
• Last Update Posted Date: August 29, 2019
• Actual Study Start Date: July 2016
• Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT02849223 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: 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: Transcranial Direct Current Stimulation (TDCS) as an Intervention for Patients With Traumatic Brain Injury
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Traumatic Brain Injury

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: August 28, 2019): 41
• Original Estimated Enrollment (submitted: July 28, 2016): 32
• Estimated Study Completion Date: January 2020
• Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02849223
• Other Study ID Numbers: 4654-A
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Tasha Nienow, Minneapolis Veterans Affairs Medical Center
• Study Sponsor: Minneapolis Veterans Affairs Medical Center

Collaborators

• State of Minnesota
• Minnesota Veterans Medical Research and Education Foundation

Investigators

• Principal Investigator: Tasha M Nienow, PhD; Minneapolis Veteran Affairs Health Care System

• PRS Account: Minneapolis Veterans Affairs Medical Center
• Verification Date: August 2019