Neuromodulation for Concussion

(CI-tDCS Trial)

Overseen by Ghazala Saleem, EdD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: State University of New York at Buffalo

Disqualifiers: Developmental delay, Learning disability, ADHD, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Mild traumatic brain injury (mTBI) often causes persistent motor and cognitive deficits in children resulting in functional limitations. We are testing a brain stimulation method along with evaluating objective tools to help record and restore communication among affected brain areas, which will facilitate recovery in youth after 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 data supports the effectiveness of the treatment tDCS for concussion?

Research suggests that transcranial direct current stimulation (tDCS) can improve cognitive performance and attention in individuals with traumatic brain injury, which is similar to concussion. Studies have shown that tDCS can enhance working memory and reaction time, indicating its potential to help with cognitive symptoms following a concussion. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Research shows that tDCS is generally safe for humans, with no serious adverse effects reported in over 33,200 sessions and 1,000 subjects, including vulnerable groups like children and the elderly. The amount of electricity used in tDCS is much lower than levels that could cause brain damage, ensuring safety when used at standard intensities and durations. ^{1 2 3 6 7}

How is the treatment tDCS different from other treatments for concussion?

Transcranial Direct Current Stimulation (tDCS) is unique because it uses a mild electrical current applied to the scalp to potentially improve cognitive function in people with concussion-related symptoms, unlike other treatments that may not directly target brain activity in this way. ^{1 2 3 5 8}

Research Team

Ghazala Saleem, EdD

Principal Investigator

State University of New York at Buffalo

Eligibility Criteria

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)

Trial Timeline

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)

Treatment Details

Interventions

• tDCS (Neuromodulation)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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]

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]

References

1. England 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. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

High-definition transcranial direct current stimulation modulates theta response during a Go-NoGo task in traumatic brain injury. [2023]

3. Sweden 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. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation modulates working memory and prefrontal-insula connectivity after mild-moderate traumatic brain injury. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Optimized high-definition tDCS in patients with skull defects and skull plates. [2023]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

8. England 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. [2020]