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

Primary Purpose

Traumatic Brain Injury

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anodal Transcranial Direct Current Stimulation
Sham stimulation
Sponsored by
Minneapolis Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Mild Traumatic Brain Injury, Transcranial Direct Current Stimulation, Working Memory

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Minneapolis Veterans Affairs Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial Direct Current Stimulation

Sham

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Wechsler Adult Intelligence Scale (WAIS)-III Working Memory Index
Standard score

Secondary Outcome Measures

University of California Performance Based Skills Assessment
Total Score

Full Information

First Posted
July 24, 2016
Last Updated
March 28, 2023
Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
State of Minnesota, Minnesota Veterans Medical Research and Education Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02849223
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2016 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
State of Minnesota, Minnesota Veterans Medical Research and Education Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Mild Traumatic Brain Injury, Transcranial Direct Current Stimulation, Working Memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Current Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Anodal Transcranial Direct Current Stimulation
Intervention Description
2 milliamps (mA) of anodal stimulation will be applied to the left dorsal lateral cortex for 20 minutes concurrent with working memory training.
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention Description
30 seconds of anodal TDCS stimulation will be applied to the left dorsal lateral cortex concurrent with working memory training
Primary Outcome Measure Information:
Title
Wechsler Adult Intelligence Scale (WAIS)-III Working Memory Index
Description
Standard score
Time Frame
Post-Intervention, 9-10 weeks after baseline assessment
Secondary Outcome Measure Information:
Title
University of California Performance Based Skills Assessment
Description
Total Score
Time Frame
Post-Intervention, 9-10 weeks after baseline assessment
Other Pre-specified Outcome Measures:
Title
Resting state electroencephalogram (EEG)
Description
Theta amplified oscillatory power
Time Frame
Post-Intervention, 8-9 weeks after baseline assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tasha M Nienow, PhD
Organizational Affiliation
Minneapolis Veteran Affairs Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis Veterans Affairs Health Care System
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States

12. IPD Sharing Statement

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

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