tDCS for Traumatic Brain Injury

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Minneapolis Veterans Affairs Medical Center

Disqualifiers: Psychotic disorder, Severe depression, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether transcranial direct current stimulation (tDCS) can help individuals with mild traumatic brain injury improve their cognitive and daily functioning. Participants will receive either real tDCS sessions or a placebo version, both paired with memory exercises. The study aims to determine if tDCS enhances brain efficiency and to identify markers that predict who benefits from the treatment. Veterans at the Minneapolis VA who experienced a mild brain injury over a year ago may qualify for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to significant findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have had a recent medication change in the last 4 weeks, you may not be eligible to participate.

What prior data suggests that transcranial direct current stimulation (tDCS) is safe for patients with mild traumatic brain injury?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe. Studies have found it can aid recovery and enhance thinking and memory in individuals with traumatic brain injury (TBI). One study found a single session of tDCS was safe for patients with severe TBI. Another review suggested that tDCS is safe and effective across various TBI severity levels.

Overall, the treatment is well-tolerated. The most common side effects are mild, including itching or tingling on the scalp where the device is applied. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for traumatic brain injury?

Unlike standard treatments for traumatic brain injury, which often focus on medications or rehabilitation therapies, transcranial direct current stimulation (tDCS) offers a non-invasive approach that directly influences brain activity. This method involves applying a mild electrical current to the scalp, targeting the left dorsal lateral prefrontal cortex to enhance working memory and cognitive function. Researchers are excited about tDCS because it has the potential to provide quicker cognitive improvements with fewer side effects compared to traditional treatments. Moreover, this technique could complement existing therapies, offering a fresh avenue for recovery that is both innovative and accessible.

What evidence suggests that transcranial direct current stimulation is effective for traumatic brain injury?

Research has shown that transcranial direct current stimulation (tDCS) can improve thinking and memory in individuals with brain conditions such as traumatic brain injury (TBI). In this trial, participants will receive either anodal tDCS or sham stimulation. Some studies have found that patients perform better on memory and thinking tests after using tDCS. Evidence also indicates that tDCS is safe for TBI patients, including those with more severe injuries. Although results for TBI remain mixed, the overall potential for tDCS to aid cognitive recovery appears promising. ^{1 2 3 6 7}

Who Is on the Research Team?

Tasha M Nienow, PhD

Principal Investigator

Minneapolis Veteran Affairs Health Care System

Are You a Good Fit for This Trial?

This trial is for veterans aged 18-65 who have had a mild traumatic brain injury over a year ago and are enrolled at the Minneapolis VA Health Care System. It's not for those with psychotic disorders, recent substance use issues, severe depression, other cognitive impairments, or medical conditions that don't allow TDCS.

Inclusion Criteria

You had a minor brain injury over a year ago that still affects you.

Veterans enrolled at the Minneapolis Veterans Affairs (VA) Health Care System

Age of 18 and 65

Exclusion Criteria

You have a mental disorder that causes you to lose touch with reality or experience hallucinations.

You have been using drugs or alcohol in small amounts over the past month.

You have had a serious problem with drug or alcohol abuse in the past six months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 24 sessions of transcranial direct current stimulation (tDCS) or sham stimulation concurrent with working memory training

12 weeks

2 sessions per week

Follow-up

Participants are monitored for cognitive and functional changes post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Anodal Transcranial Direct Current Stimulation
• Sham stimulation

Trial Overview The study tests if transcranial direct current stimulation (TDCS) can improve cognition in patients with mild traumatic brain injury. Participants will be randomly assigned to receive either real TDCS or sham stimulation alongside working memory training.

How Is the Trial Designed?

Group I: Transcranial Direct Current Stimulation Experimental Treatment 1 Intervention

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 II: Sham Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Minneapolis Veterans Affairs Medical Center

Lead Sponsor

Trials

77

Recruited

355,000+

Minnesota Veterans Medical Research and Education Foundation

Collaborator

Trials

4

Recruited

170+

State of Minnesota

Collaborator

Trials

1

Recruited

40+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6601308/

Transcranial direct current stimulation (tDCS) effects on ... Multiple studies showed improved coma recovery scales in disorders of consciousness, and improved cognition on neuropsychological assessments.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10448524/

Is transcranial direct current stimulation (tDCS) effective to ... Transcranial direct current stimulation (tDCS) seems to be a good therapeutic option, but when it comes to patients with sTBI, the results are inconclusive.

3. frontiersin.org frontiersin.org/journals/neuroergonomics/articles/10.3389/fnrgo.2023.1170473/full

A map of evidence using transcranial direct current ... Limited but promising evidence supports tDCS as safe and effective for cognition across all levels of TBI acuity and severity (Begemann et al., ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666459324000088

The safety and feasibility of transcranial direct current ... Our phase I safety study indicated that a single course of tDCS was safe in patients with severe traumatic brain injury.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04540783

The Effects of Transcranial Direct Current Stimulation ... Analysis of the results will be done by intention to treat (ITT). Official Title. The Effects of Transcranial Direct Current Stimulation (tDCS) and Cognitive ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06228872

"Cognitive Rehabilitation With Direct Current Transcranial ... Transcranial Direct Current Stimulation (tDCS) has shown effectiveness in enhancing neuroplasticity in various neurological and psychiatric conditions 63.

7. bmjopen.bmj.com bmjopen.bmj.com/content/11/8/e045285

Effects of transcranial direct current stimulation (tDCS) and ... Transcranial direct current stimulation (tDCS) and concurrent cognitive training may contribute to improve episodic memory in patients with TBI.