Transcranial Direct Current Stimulation (TDCS) as an Intervention for Patients With Traumatic Brain Injury
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2016
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 24, 2016
CompletedFirst Posted
Study publicly available on registry
July 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
October 9, 2025
June 1, 2025
10.2 years
July 24, 2016
October 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wechsler Adult Intelligence Scale (WAIS)-III Working Memory Index
Standard score
Post-Intervention, 12 weeks after baseline assessment
Secondary Outcomes (1)
University of California Performance Based Skills Assessment
Post-Intervention, 12 weeks after baseline assessment
Study Arms (2)
Transcranial Direct Current Stimulation
EXPERIMENTALParticipants will receive 24 sessions (2 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.
Sham
SHAM COMPARATORParticipants 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.
Interventions
2 milliamps (mA) of anodal stimulation will be applied to the left dorsal lateral cortex for 20 minutes concurrent with working memory training.
30 seconds of anodal TDCS stimulation will be applied to the left dorsal lateral cortex concurrent with working memory training
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Minneapolis Veterans Affairs Health Care System
Minneapolis, Minnesota, 55417, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tasha M Nienow, PhD
Minneapolis Veteran Affairs Health Care System
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Psychologist
Study Record Dates
First Submitted
July 24, 2016
First Posted
July 29, 2016
Study Start
July 1, 2016
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
October 9, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share