Electrical Stimulation Therapy for Post-Concussion Syndrome

Overseen By Thorsten Rudroff, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Must not be taking: Psychoactive medications

Disqualifiers: Seizure disorders, Diabetes, Psychosis, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of transcranial direct current stimulation (a type of mild brain stimulation) on individuals with post-concussion syndrome from sports injuries. Researchers aim to determine if this treatment can improve cognition and balance while reducing symptoms like headaches and dizziness. The study includes two main groups: one receiving real brain stimulation and another receiving a placebo version for comparison. Individuals who experienced a sports-related concussion over a month ago and have symptoms like headaches or memory problems might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new treatments for post-concussion syndrome.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that participants are not on any prescribed psychoactive medications.

What prior data suggests that this electrical stimulation therapy is safe for post-concussion syndrome?

Research shows that transcranial direct current stimulation (tDCS) is generally safe for people. The electric current used is very low, typically between 1 to 2 milliamps. Studies have shown that a single session of tDCS is safe even for individuals with severe brain injuries. Other research has found it safe when combined with exercise to treat certain headaches. Overall, tDCS is well-tolerated, with few side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for post-concussion syndrome, like medication and cognitive therapy, focus on managing symptoms rather than addressing the underlying brain changes. But Transcranial Direct Current Stimulation (tDCS) works differently by directly targeting brain activity. Researchers are excited because tDCS uses a mild electrical current to stimulate specific areas of the brain, potentially speeding up recovery and improving brain function. This method is non-invasive and could offer a quicker, more direct way to help the brain heal from concussions compared to traditional treatments.

What evidence suggests that transcranial direct current stimulation is effective for post-concussion syndrome?

Research has shown that transcranial direct current stimulation (tDCS) might improve thinking skills in people with post-concussion symptoms. In this trial, participants in the Active Group will receive the active form of tDCS, while those in the Sham Group will receive a sham form. For instance, one study found that people using tDCS performed better on memory tests than those who received a fake treatment. Another study found that tDCS improved memory and decision-making skills in people with mild brain injuries. While results can vary, these findings suggest that tDCS could be a promising way to help people with post-concussion syndrome. However, more research is needed to confirm these benefits in larger groups. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-30 who have been diagnosed with a concussion from sports at least one month ago and are experiencing symptoms like headaches, dizziness, or memory issues. They must be able to use a phone, agree to follow the study plan, and be healthy enough as determined by clinical exam.

Inclusion Criteria

You recently had a concussion while playing sports or doing recreational activities.

I had a traumatic brain injury over a month ago.

Sign the agreement that explains the details of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 consecutive daily sessions of 2 mA right cerebellar tDCS

1 week

5 visits (in-person)

Follow-up

Participants are monitored for improvements in cognitive deficits, balance, and symptom attenuation

4 weeks

2 visits (in-person) at 2 and 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation

Trial Overview The study tests if cerebellar transcranial direct current stimulation (tDCS) can improve cognition, balance, and reduce symptoms in people with post-concussion syndrome from sports. It checks immediate effects and changes after 2 and 4 weeks.

How Is the Trial Designed?

Group I: Healthy Controls Active Control 1 Intervention

These will be age and sex-matched healthy controls who only come in for the baseline visit in order to provide comparative values with which to confirm adequate impairment in our diseased population.

Group II: Active Group Active Control 1 Intervention

This group will receive the active form of tDCS. The tDCS will be administered with the anode over the right lobule of the cerebellum, and the cathode over the left lobule of the cerebellum. Stimulation will be administered for a twenty minute period that does not include the 30 second ramp up at the beginning and end of the stimulation.

Group III: Sham Group Placebo Group 1 Intervention

This group will receive the sham form of tDCS. The electrodes will be placed in the same montage as in the Active group, however the stimulation parameters are different. For this group, the stimulation will be ramped up to the target intensity over thirty seconds at the beginning, then immediately ramp down over thirty seconds. The stimulation will then remain off for the next twenty minutes. After twenty minutes the stimulation will ramp up to the target intensity and then back down over thirty seconds.

Transcranial Direct Current Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Chronic pain management
• Depression
• Anxiety

Approved in European Union as Transcranial Direct Current Stimulation for:

• Chronic pain management
• Neurological rehabilitation

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Published Research Related to This Trial

In a study involving 20 patients with posttraumatic encephalopathy, high-definition transcranial direct current stimulation (HD-tDCS) significantly improved cerebral blood flow (CBF) and cerebral blood volume (CBV), indicating enhanced oxygen delivery to brain tissue.

The treatment also reduced areas of hypoperfusion and ischemia, suggesting that HD-tDCS may be an effective non-pharmacologic intervention for improving cerebral perfusion after traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral Hemodynamics After Transcranial Direct Current Stimulation (tDCS) in Patients with Consequences of Traumatic Brain Injury. Trofimov, AO., Kalentiev, G., Karelsky, M., et al.[2020]

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]

A systematic review of 64 studies involving 2262 participants found that transcranial direct current stimulation (tDCS) has a low dropout rate (6% for active and 7.2% for sham), indicating good acceptability among participants.

Despite the low dropout rates, many studies inadequately reported adverse events (AEs), highlighting a need for improved guidelines to standardize AE reporting in tDCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Aparício, LVM., Guarienti, F., Razza, LB., et al.[2018]

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]

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 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]

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]

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) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

In a study involving 26 patients with traumatic brain injury (TBI), 10 sessions of anodal transcranial direct current stimulation (tDCS) significantly reduced theta, delta, and increased alpha EEG oscillations, indicating a positive modulation of brain activity.

Improvements in neuropsychological test performance were strongly correlated with the reduction of delta waves in the active tDCS group, suggesting that tDCS may enhance cognitive recovery in TBI patients during neurorehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cumulative effects of transcranial direct current stimulation on EEG oscillations and attention/working memory during subacute neurorehabilitation of traumatic brain injury. Ulam, F., Shelton, C., Richards, L., et al.[2022]

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]

Citations

1. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2023.1162854/full

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.

2. nature.com nature.com/articles/s41598-019-41923-6

A Pilot Randomised Double-Blind Study of the Tolerability ... The results support rTMS as a tolerable and potentially effective treatment option for individuals with a recent (<1 year) concussion. Similar ...

3. cochranelibrary.com cochranelibrary.com/content;jsessionid=AF6C40B78561A4771BC81957FC17E0E8?templateType=related&urlTitle=/central/doi/10.1002/central/CN-01589260&doi=10.1002/central/CN-01589260&p_p_id=scolariscontentdisplay_WAR_scolariscontentdisplay&_scolariscontentdisplay_WAR_scolariscontentdisplay_action=related-content&p_p_lifecycle=0&p_p_mode=view&type=central&contentLanguage=

Post-concussion and Transcranial Direct Current Stimulation Exploring tDCS-induced changes in EEG power and network connectivity in youth concussion: preliminary findings · Abstract #63: the Effect of tDCS on Cognitive ...

4. tandfonline.com tandfonline.com/doi/abs/10.1080/02699052.2022.2034179

The effect of transcranial direct current stimulation on ... Active tDCS group performed better than sham on Day 2 in N-Back level N2 (p = .019), and marginally better than the sham group on Day 3 in level N3 (p = .26).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5411433/

Transcranial Direct Current Stimulation for Post- ... This is a randomized crossover trial of patients with a history of MTBI with cognitive deficits in memory and executive function.

6. 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.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12005617/

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. While some promise ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2451865424001170

The safety and feasibility of transcranial direct current ... This trial aims to demonstrate the safety and feasibility of tDCS in combination with ET for the treatment of CGH.