Transcranial Direct Current Stimulation for Post-Concussion Syndrome

Overseen By Melanie Stimac

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Moderate/severe TBI, Neurological disorders, Psychiatric disorders, Substance dependence, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with persistent post-concussion syndrome (PPCS) feel better after a mild traumatic brain injury (mTBI). It combines a gentle brain stimulation method called transcranial direct current stimulation (tDCS) with mental exercises to see if symptoms improve. Participants will join one of two groups: one receiving active brain stimulation (Active tDCS) and the other receiving sham (fake) stimulation (Sham tDCS), both alongside cognitive training. Individuals who have experienced a single mild brain injury within the past year and have ongoing symptoms might be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for PPCS.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that transcranial direct current stimulation is safe for individuals with post-concussion syndrome?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe. One study found that a single session of tDCS was safe for individuals with severe brain injuries. Another study demonstrated that tDCS, when combined with other treatments, was safe, practical, and well-received.

While results can vary, these findings suggest that tDCS is usually well-tolerated with few serious side effects. However, individual experiences can differ, so discussing any concerns with a healthcare professional is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Direct Current Stimulation (tDCS) for Post-Concussion Syndrome is unique because it uses a non-invasive technique to stimulate the brain. Unlike standard treatments that often rely on medications and physical therapy, tDCS involves a gentle electrical current to potentially enhance brain function and cognitive recovery. Researchers are excited because this method may offer a new way to help patients improve without the side effects associated with drugs. Additionally, the inclusion of cognitive training alongside tDCS could amplify its benefits, providing a more comprehensive approach to managing post-concussion symptoms.

What evidence suggests that this trial's treatments could be effective for post-concussion syndrome?

This trial will compare the effects of Active tDCS with Sham tDCS, both combined with Cognitive Training, for individuals with persistent post-concussive syndrome (PPCS). Research has shown that transcranial direct current stimulation (tDCS) may help people with ongoing symptoms after a mild brain injury. In one study, participants who received real tDCS performed better on memory tests than those who received a sham treatment. Another study found that tDCS significantly reduced the number of headache days each month for patients. These findings suggest that tDCS might improve thinking skills and lessen symptoms in people with PPCS. Early results are promising, but more research is needed to confirm its effectiveness. ^{1 2 6 7 8}

Who Is on the Research Team?

Kelvin Lim, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-65 who have persistent cognitive symptoms after a mild traumatic brain injury (mTBI) that occurred 3-12 months ago. Participants must meet the criteria for post-concussive syndrome, have access to a smartphone, and be able to consent. Those with metal implants, scalp issues, severe TBI history, major neurological/psychiatric disorders or recent substance dependence cannot join.

Inclusion Criteria

Meets criteria for PPCS (assessed using the CP Screen)

Has reliable access to a smartphone

I am between 18 and 65 years old.

Exclusion Criteria

I am unable to understand or follow the study's procedures.

I don't have metal implants or skin issues on my head.

History of moderate/severe TBI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active or sham tDCS combined with cognitive training

4 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active tDCS
• Sham tDCS

Trial Overview The study tests whether using transcranial direct current stimulation (tDCS), combined with cognitive training, can improve brain function in people with long-lasting symptoms after a concussion. It compares active tDCS treatment against sham (placebo-like) tDCS to see which is more effective.

How Is the Trial Designed?

Group I: Active tDCS + Cognitive Training Active Control 1 Intervention

Group II: Sham tDCS + Cognitive Training Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

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

Transcranial Direct Current Stimulation for Post- ... The purpose of this study is to determine the early effects of a single session tDCS in patients with MTBI and PPCS with cognitive deficits in long-term ...

2. 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.

3. 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 ...

4. mdpi.com mdpi.com/2076-3425/11/6/806

Transcranial Direct Current Stimulation as a Treatment ... The primary outcome for treatment effectiveness was a ≥50% decrease in the number of days with headaches per month. Secondary outcomes included ...

5. 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).

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

The safety and feasibility of transcranial direct current ... We found tDCS + ET was safe, feasible, and tolerable. Secondary outcomes suggested active tDCS + ET was superior to sham tDCS + ET when ...

8. 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.