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

NCT ID: NCT02849223

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2026-09-30

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Transcranial Direct Current Stimulation

Participants 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.

Group Type: EXPERIMENTAL

Anodal Transcranial Direct Current Stimulation

Intervention Type: DEVICE

2 milliamps (mA) of anodal stimulation will be applied to the left dorsal lateral cortex for 20 minutes concurrent with working memory training.

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.

Group Type: SHAM_COMPARATOR

Sham stimulation

Intervention Type: DEVICE

30 seconds of anodal TDCS stimulation will be applied to the left dorsal lateral cortex concurrent with working memory training

Interventions

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.

Intervention Type: DEVICE

Sham stimulation

30 seconds of anodal TDCS stimulation will be applied to the left dorsal lateral cortex concurrent with working memory training

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State of Minnesota

UNKNOWN

Sponsor Role: collaborator

Minnesota Veterans Medical Research and Education Foundation

OTHER

Sponsor Role: collaborator

Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Tasha Nienow

Staff Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tasha M Nienow, PhD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Veteran Affairs Health Care System

Locations

Minneapolis Veterans Affairs Health Care System

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

4654-A

Identifier Type: -

Identifier Source: org_study_id