Neuromodulation for Concussion

(CI-tDCS Trial)

Overseen By Ghazala Saleem, EdD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Developmental delay, Learning disability, ADHD, others

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

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a brain stimulation method called transcranial direct current stimulation (tDCS) to aid children in recovering from mild traumatic brain injuries (mTBI), such as concussions. The researchers aim to determine if tDCS can improve communication between brain areas to alleviate motor and cognitive issues. Children who have experienced a concussion in the past year and face symptoms like difficulty with planning or movement may be suitable candidates. Healthy children without a concussion history will also participate for comparison. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance recovery methods for children with mTBI.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that this brain stimulation method is safe for children with mild traumatic brain injury?

Research shows that transcranial direct current stimulation (tDCS) is generally safe for people. Studies have found no serious side effects, such as brain injury, linked to tDCS use. This brain stimulation method is also considered safe and well-tolerated in children, which is crucial for this trial focusing on young people with mild traumatic brain injury.

In past studies, researchers used tDCS alongside other therapies and found it safe and practical. While research continues, early results are promising for its use in improving thinking skills. Overall, tDCS is viewed as a low-risk treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for mild traumatic brain injury, which often involves rest and symptom management, transcranial direct current stimulation (tDCS) offers a unique approach by directly modulating brain activity. tDCS uses a low electrical current, delivered through electrodes placed on the scalp, to target specific brain regions affected by concussion. Researchers are excited about tDCS because it has the potential to improve recovery by enhancing neural plasticity and cognitive function, providing a non-invasive and potentially faster-acting alternative to conventional treatments.

What evidence suggests that transcranial direct current stimulation (tDCS) might be an effective treatment for mild traumatic brain injury (mTBI)?

This trial will evaluate the effects of transcranial direct current stimulation (tDCS) in youth with mild traumatic brain injury (mTBI). Research has shown that tDCS can improve movement and thinking skills, with studies finding it aids recovery after a stroke by enhancing these abilities. Evidence also suggests that tDCS can enhance thinking skills in various conditions. Although researchers have studied tDCS less in mTBI, its potential to help the brain change and adapt suggests it might repair brain areas affected by mTBI. In summary, early findings are promising for tDCS as a way to aid recovery in mTBI, but more research is needed to confirm its benefits for this condition. ^{1 6 7 8 9}

Who Is on the Research Team?

Ghazala Saleem, EdD

Principal Investigator

State University of New York at Buffalo

Are You a Good Fit for This Trial?

This trial is for children aged 10-15 who have had a mild traumatic brain injury (mTBI) or concussion in the past year and are experiencing ongoing symptoms like trouble with motor skills. They must be at least 6 weeks post-injury, speak English fluently, and have no prior history of concussions.

Inclusion Criteria

age 10-15 years at enrollment

enrolled after 6 weeks of mTBI injury

exhibiting post-concussive symptoms (e.g., difficulty planning, sequencing, and executing a motor action)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Initial behavioral and neuroimaging testing conducted

1 week

1 visit (in-person)

Treatment

Ten sessions of 1.5 mA real tDCS and 10 sessions of sham tDCS administered with a 2-week washout period

8 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview The study is exploring the use of tDCS (transcranial direct current stimulation), a non-invasive brain stimulation technique, to improve motor and cognitive functions in youths with mTBI. It also aims to assess new ways to measure brain communication changes during recovery.

How Is the Trial Designed?

Group I: tDCS in Youth with mild traumatic brain injury Experimental Treatment 1 Intervention

Behavioral as well as neuroimaging measurements will be administered at the final post-anodal transcranial direct current stimulation (tDCS), final post-sham tDCS, and at 30-day follow-up visits. tDCS will be administered after the initial behavioral and neuroimaging testing. Ten sessions of 1.5 mA real tDCS and 10 sessions of sham tDCS will be administered using Neurocom (Germany) DC stimulator and two 5x7 electrodes, moistened in saline solution, to 10 participants with mTBI following a cross-over design with a 2-week washout period. The location of the brain regions will be determined using either the Transcranial Magnetic Stimulation Neuronavigation or Brainsight Neuronavigation system. The anode will be placed over pre-determined brain regions, whereas the cathode will be placed either over Fp2 (contralateral supraorbital) or other suitable reference areas.

Group II: Healthy Controls Active Control 1 Intervention

Never-concussed age-and gender-matched healthy controls will not receive any intervention. Behavioral and neuroimaging measurements will be administered only once, at the initial visit.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) has been found to be safe for use in humans, with no severe complications reported in studies involving both adults and children when applied at intensities of 4 mA or less for up to 60 minutes.

Animal studies indicate that the electrical current used in tDCS is significantly lower than the threshold that could cause permanent changes to brain tissue, suggesting a strong safety profile for this neurorehabilitation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. Ko, MH.[2023]

Transcranial direct current stimulation (tDCS) showed promising early efficacy in improving working memory performance in youth with cognitive persistent post-concussion symptoms, particularly on a dual task working memory test.

The study found that participants tolerated tDCS well, with the active tDCS group reporting fewer strong symptoms compared to the sham group, suggesting it could be a feasible adjunct to behavioral therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of transcranial direct current stimulation on cognitive performance in youth with persistent cognitive symptoms following concussion: a controlled pilot study. Quinn de Launay, K., Cheung, ST., Riggs, L., et al.[2022]

In a study involving veterans with chronic traumatic brain injury (TBI), active high-definition transcranial direct current stimulation (HD-tDCS) significantly improved cognitive performance, as evidenced by increased theta activity in the brain during a Go-NoGo task, compared to a sham treatment.

The results suggest that HD-tDCS induces specific changes in brain oscillatory activity, which could help identify individuals who are more likely to benefit from this type of intervention in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-definition transcranial direct current stimulation modulates theta response during a Go-NoGo task in traumatic brain injury. Chiang, HS., Motes, M., Kraut, M., et al.[2023]

Optimized high-definition montages for transcranial direct current stimulation (tDCS) can increase stimulation intensity by an average of 0.3 V/m compared to unoptimized montages, which is crucial for targeting areas beneath skull defects.

Large skull defects with titanium or acrylic plates can reduce stimulation intensity by about 80%, while smaller defects filled with cerebrospinal fluid or scar tissue can increase stimulation intensity by about 200%, highlighting the importance of individual anatomical considerations in tDCS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimized high-definition tDCS in patients with skull defects and skull plates. Guillen, A., Truong, DQ., Datta, A., et al.[2023]

A single session of anodal transcranial direct current stimulation (tDCS) to the left dorsolateral prefrontal cortex showed a tendency to improve reaction times in patients with traumatic brain injury, suggesting potential benefits for attention improvement.

While the immediate effects were promising, the improvements were not statistically significant after 3 or 24 hours, indicating that further research is needed to confirm the efficacy of tDCS in enhancing attention in this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation of the left prefrontal cortex improves attention in patients with traumatic brain injury: a pilot study. Kang, EK., Kim, DY., Paik, NJ.[2022]

In a study of 34 individuals with mild-moderate traumatic brain injury (mmTBI), active transcranial direct current stimulation (tDCS) combined with executive function training led to greater improvements in working memory reaction times compared to a control group.

The improvements in reaction time were linked to changes in brain connectivity between the right dorsolateral prefrontal cortex and the left anterior insula, suggesting a potential mechanism for recovery from persistent posttraumatic symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation modulates working memory and prefrontal-insula connectivity after mild-moderate traumatic brain injury. Quinn, DK., Story-Remer, J., Brandt, E., et al.[2023]

This study will investigate the safety and efficacy of combining transcranial direct current stimulation (tDCS) with conventional rehabilitation in 80 patients with disorders of consciousness (DOC) after traumatic brain injury (TBI) over a 4-week period.

The trial aims to provide advanced evidence for tDCS as a non-invasive treatment option to promote early awakening in DOC patients, addressing a significant gap in large-sample clinical trials for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation on patients with disorders of consciousness after traumatic brain injury: study protocol for a randomized, double-blind controlled trial. Li, S., Dong, X., Sun, W., et al.[2020]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8235194/

Transcranial Direct Current Stimulation as a Treatment Tool ... Based on the review, there is limited evidence of tDCS improving cognitive and motor performance. Surprisingly, there were only three studies that used tDCS in ...

2. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2025.1552387/full

Transcranial direct current stimulation in individuals with ... Research has demonstrated positive results from the application of tDCS after stroke, such as improved motor and cognitive function, when tDCS ...

3. 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.

4. 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.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0278584623001495

Effectiveness of rTMS and tDCS treatment for chronic TBI ... This study aims at providing a systematic review and meta-analysis on the effectiveness of repetitive transcranial magnetic stimulation (TMS) and transcranial ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ... In this review, tDCS safety indicates the absence of a Serious Adverse Effect including brain tissue injury related to tDCS application. It is necessary to ...

7. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14887

The safety and feasibility of transcranial direct current ... Conclusion. The combination of transcranial direct stimulation and exercise therapy is safe and feasible for treating cervicogenic headache.

8. 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., ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X19304966

Safety and tolerability of transcranial magnetic and direct ... Standard non-invasive brain stimulation paradigms are safe and well-tolerated in children and should be considered minimal risk.