Brain Stimulation for Epilepsy

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Stanford University

Must be taking: Anti-seizure medicines

Disqualifiers: Psychogenic seizures, Suicide attempt, others

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

Compensation: Varies

Number of Visits: 6

Duration: 1 month

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a placebo-controlled study of the effectiveness of transcranial direct current stimulation (tDCS) at home to reduce seizures and EEG spikes.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. You need to keep your medication the same during the study, but rescue medications are allowed.

What data supports the effectiveness of the treatment tDCS for epilepsy?

Research shows that transcranial direct current stimulation (tDCS) can help reduce seizure activity and abnormal brain waves in some patients with epilepsy, especially in cases where other treatments have not worked well. Some studies have shown benefits in reducing seizures and brain activity spikes, although results can vary. ^{1 2 3 4 5}

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

Transcranial direct current stimulation (tDCS) has been used in over 33,200 sessions with more than 1,000 people, including potentially vulnerable groups, without any reports of serious or lasting harm. While some people may experience mild skin irritation, the overall risk of serious side effects is considered low. ^{2 6 7 8 9}

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

Transcranial Direct Current Stimulation (tDCS) is unique because it is a non-invasive treatment that uses a small electrical current applied to the scalp to help reduce seizures, unlike traditional drug therapies. It works by modulating brain activity and is particularly useful for patients who do not respond well to medications. ^{1 2 3 5 10}

Eligibility Criteria

This trial is for adults aged 18-100 with epilepsy, experiencing at least four seizures per month and who haven't found seizure control with two or more anti-seizure medications. Participants must be able to keep their medication constant, understand consent in English, and maintain a seizure diary. It's not suitable for those with certain psychiatric conditions, skin issues affecting electrode placement, or women who are pregnant.

Inclusion Criteria

Age 18-100, inclusive.

Able to maintain a constant medication for duration of the study (rescue meds allowed)

Subject or legally authorized representative is able to understand consent and keep a seizure diary in English

Exclusion Criteria

You have non-epileptic seizures caused by psychological factors.

You have attempted suicide or been hospitalized for a mental health issue within the past 2 years.

Women will verify not pregnant, and if applicable, have a serum pregnancy test

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 month

1 visit (in-person)

Baseline

Participants maintain a seizure diary and undergo baseline EEG and neuropsychological testing

1 month

1 visit (in-person), weekly phone contacts

Treatment

Participants receive either SHORT or LONG tDCS treatment at home

1 month

1 visit (in-person), weekly phone contacts

Wash-out

No treatment is administered to allow for wash-out period

1 month

1 visit (in-person)

Second Treatment

Participants receive the alternate tDCS treatment (LONG or SHORT) at home

1 month

1 visit (in-person), weekly phone contacts

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

1 visit (in-person), weekly phone contacts

Treatment Details

Interventions

• tDCS

Trial Overview The study tests if using transcranial direct current stimulation (tDCS) at home can reduce the number of seizures and EEG spikes in people with epilepsy. This placebo-controlled study means some participants will receive the tDCS treatment while others will get a sham procedure without any active intervention.

Participant Groups

Group I: Long Stimulation Experimental Treatment 1 Intervention

30 minutes duration of stimulation per day for 30 days

Group II: Short Stimulation Active Control 1 Intervention

1 minute duration of stimulation per day for 30 days

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

Transcranial direct current stimulation (tDCS) significantly reduced interictal spike counts in rats with chronic seizures immediately after treatment, suggesting its potential efficacy in modulating epileptic activity.

The study found that enhanced delta oscillations during tDCS may underlie its inhibitory effects on seizure excitability, while changes in BDNF protein expression indicate a complex interaction between tDCS and neural mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delta oscillation underlies the interictal spike changes after repeated transcranial direct current stimulation in a rat model of chronic seizures. Wu, YJ., Chien, ME., Chiang, CC., et al.[2022]

Transcranial direct current stimulation (tDCS) has shown preliminary safety and efficacy in reducing epileptic seizures in both animal studies and clinical trials involving 65 human participants, with 67% of studies reporting effective seizure reduction.

All patients tolerated tDCS well, indicating a favorable safety profile, but further research is needed to establish optimal stimulation protocols and assess long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Epilepsy. San-Juan, D., Morales-Quezada, L., Orozco Garduño, AJ., et al.[2018]

Spaced transcranial direct current stimulation (tDCS) significantly reduced interictal epileptiform discharges (IEDs) by up to 68% and decreased seizure frequency in 15 adults with drug-resistant focal epilepsy, indicating its efficacy as a treatment option.

The treatment was well tolerated with no severe adverse events reported, suggesting that tDCS is a safe intervention for patients with unifocal epilepsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of spaced cathodal transcranial direct current stimulation in drug resistant focal epilepsies. Kaufmann, E., Hordt, M., Lauseker, M., et al.[2021]

Transcranial direct current stimulation (tDCS) applied at 2 mA over the seizure focus in four patients with focal status epilepticus led to significant reductions in interictal spikes and electrographic seizures, demonstrating its potential efficacy in critical care settings.

The treatment was well-tolerated with only minor side effects, and it allowed for reductions in antiseizure medications, suggesting a promising role for tDCS in managing refractory seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for focal status epilepticus or lateralized periodic discharges in four patients in a critical care setting. Fisher, RS., McGinn, RJ., Von Stein, EL., et al.[2023]

A systematic review of 158 studies involving 4130 participants found that repeated sessions of transcranial direct current stimulation (tDCS) do not significantly increase the risk of adverse events compared to sham treatments.

The study indicated that adverse event rates were consistent across different diagnostic groups, suggesting that tDCS is generally safe for various populations, although the potential for rare adverse events cannot be completely excluded.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of repeated sessions of transcranial direct current stimulation: A systematic review. Nikolin, S., Huggins, C., Martin, D., et al.[2019]

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]

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]

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 of 12 patients with drug-resistant mesial temporal lobe epilepsy with hippocampal sclerosis, cathodal transcranial direct current stimulation (tDCS) significantly reduced seizure frequency from an average of 10.58 to 1.67 seizures per month (p=0.003).

Eighty-three percent of patients experienced more than a 50% reduction in seizures after tDCS, with 50% becoming seizure-free for one month, indicating that tDCS could be a promising additional treatment option for patients awaiting or rejecting surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of transcranial direct current stimulation on seizure frequency of patients with mesial temporal lobe epilepsy with hippocampal sclerosis. Tekturk, P., Erdogan, ET., Kurt, A., et al.[2019]

References

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

Delta oscillation underlies the interictal spike changes after repeated transcranial direct current stimulation in a rat model of chronic seizures. [2022]

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

Transcranial Direct Current Stimulation in Epilepsy. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) in the management of epilepsy: A systematic review. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Acute effects of spaced cathodal transcranial direct current stimulation in drug resistant focal epilepsies. [2021]

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

Transcranial direct current stimulation for focal status epilepticus or lateralized periodic discharges in four patients in a critical care setting. [2023]

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

Safety of repeated sessions of transcranial direct current stimulation: A systematic review. [2019]

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

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

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

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of transcranial direct current stimulation on seizure frequency of patients with mesial temporal lobe epilepsy with hippocampal sclerosis. [2019]