HD-EEG for Nervous System Disorders

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Stroke, Tumor, Psychosis, others

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

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to use a high-density electroencephalogram (HD-EEG) to map brain areas controlling movement, sensation, language, emotion, and cognition. It seeks to determine how this new technology can assist individuals with conditions such as epilepsy, brain tumors, nerve problems, and recent strokes. The trial will compare results with those from healthy participants. Individuals who can perform tasks and provide their own consent may be suitable candidates for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could enhance future diagnostic and treatment methods.

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 might be best to ask the trial organizers for more details.

What prior data suggests that this method is safe for mapping brain areas?

Research has shown that high-density EEG, a method for studying brain activity, is safe. Studies have found it can be used safely alongside high-speed fMRI, a type of brain scan, without causing harm. This is reassuring for people with epilepsy, brain tumors, nerve issues, or those who have had a stroke.

For people with epilepsy, high-density EEG has helped plan surgeries without any reported harm. In patients with brain tumors, it safely maps brain activity. Studies on nerve issues also confirm its safety. Lastly, in stroke patients, high-density EEG safely provides insights into brain recovery.

Overall, research supports that high-density EEG is well-tolerated and poses little risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using High-density EEG (HD-EEG) for nervous system disorders because it offers unprecedented precision in brain localization. Unlike traditional EEG, which uses fewer electrodes, HD-EEG employs a high number of electrodes to capture detailed brain activity. This method can pinpoint areas of the brain involved in conditions like epilepsy, tumors, peripheral nerve dysfunction, and stroke more accurately. By improving localization, HD-EEG could lead to better-targeted treatments, potentially enhancing outcomes and reducing side effects. This precision is what sets HD-EEG apart from current diagnostic techniques, like standard EEG or neuroimaging, making it a promising tool in the field of neurology.

What evidence suggests that this trial's use of HD-EEG could be effective for nervous system disorders?

Research has shown that high-density EEG (HD-EEG) is a promising tool for identifying brain activity in conditions like epilepsy, tumors, nerve disorders, and stroke. This trial will explore HD-EEG's effectiveness across different groups. In the epilepsy arm of this trial, studies indicate that HD-EEG can accurately locate seizure origins in up to 80% of patients, even when MRI scans appear normal. For the tumor patient arm, HD-EEG uncovers unique changes in brain networks, aiding in understanding and improving treatment choices. In the nerve disorder arm, HD-EEG effectively spots changes in brain networks, assisting with diagnosis and predicting outcomes. For stroke patients, HD-EEG detects specific brain activity changes that might predict recovery, providing valuable insights into patient prognosis. Overall, HD-EEG serves as a powerful tool for understanding and potentially improving treatment for various nervous system disorders. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who can perform specific tasks and give consent on their own. It's suitable for those with epilepsy, healthy subjects, or other nervous system disorders. People with conditions like stroke, tumors, or psychosis that could affect EEG results cannot participate.

Inclusion Criteria

Able to give own consent

I can do the tasks required in the study.

Exclusion Criteria

I do not have any brain conditions like stroke or psychosis that could affect EEG tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

High-density EEG recordings are conducted to localize brain functions in patients and healthy controls

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for any immediate effects or reactions post-EEG recording

1 week

What Are the Treatments Tested in This Trial?

Interventions

• High-density electroencephalogram (HD-EEG)

Trial Overview The study is testing a new method called high-density electroencephalogram (HD-EEG) to map brain functions related to movement, sensation, language, emotion, and thinking in people with neurological conditions.

How Is the Trial Designed?

Group I: High-density EEG localization in tumor patients Experimental Treatment 1 Intervention

High-density EEG will be used for brain localization in tumor patients

Group II: High-density EEG localization in stroke patients Experimental Treatment 1 Intervention

High-density EEG will be used for brain localization in patients who have recently experienced a stroke

Group III: High-density EEG localization in peripheral nerve patients Experimental Treatment 1 Intervention

High-density EEG will be used for brain localization in patients with peripheral nerve dysfunction

Group IV: High-density EEG localization in epilepsy Experimental Treatment 1 Intervention

High-density EEG will be used for brain localization in epilepsy patients

Group V: High-density EEG localization in healthy controls Active Control 1 Intervention

High-density EEG will be used for brain localization in healthy controls

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1388245725004420

The role of high-density EEG in diagnosis and prognosis ... HD-EEG is effective to detect biomarkers for the diagnosis in neurological disorders, contributing to avoid misdiagnosis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10472417/

Feasibility of high‐density electric source imaging in the ... In line with our results, a study of Brodbeck et al. reported the correct localization of the epileptogenic focus by ESI in 80% of patients with normal MRI.

3. thejns.org thejns.org/view/journals/j-neurosurg/140/3/article-p880.xml

High-density electric source imaging patterns and outcomes ... A specific ESI pattern that was highly associated with no seizure recurrence following surgery was demonstrated by a 256-channel HD-EEG.

4. ucsf.edu ucsf.edu/news/2025/03/429641/lo-res-hi-res-better-way-pinpoint-where-seizures-begin

Lo-Res to Hi-Res, A Better way to Pinpoint Where Seizures ... UCSF study shows that higher electrode density enhances the ability of physicians to find where seizures start in patients with drug-resistant epilepsy.

5. nature.com nature.com/articles/s41598-024-56827-3

High-performance prediction of epilepsy surgical outcomes ... This study suggests that the hybrid iEEG marker can improve the performance of model predicting the epilepsy surgical outcomes.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28552957/

Safety and EEG data quality of concurrent high-density ... This study demonstrates that high-density EEG can be safely implemented in conjunction with high-speed fMRI and that high-speed fMRI does not adversely ...

7. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0178409

Safety and EEG data quality of concurrent high-density EEG ... This study demonstrates that high-density EEG can be safely implemented in conjunction with high-speed fMRI and that high-speed fMRI does not adversely affect ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0303846722002177

Impact of high-density EEG in presurgical evaluation for ... HD-EEG assists presurgical planning for refractory epilepsy patients, with a higher yield in patients with non-lesional MRIs.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12239892/

Feasibility, Safety, and Performance of Full-Head Subscalp ... We developed a device for full-head subscalp EEG (Epios) and tested here the feasibility to safely insert the electrode leads beneath the scalp ...