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New treatment option for Epilepsies
Official title Home Ultra-long Term EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies
ClinicalTrials.gov ID: NCT06855901
What this study is testing
- What it's testing
- With this study the Investigator expects to develop a precise patient-centered model of care by means of home ultra-long-term EEG monitoring with a minimally invasive wearable EEG device (sqEEG). The following aims will be pursued: 1.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Age \> 12 years old, with or without intellectual disabilities;
- Diagnosis of drug resistant seizures, DEE or rare epilepsies ;
- One or more seizure types as established by previous epilepsy history thus allowing to define seizure type and scalp topography of the ictal...
- Availability for the duration of the study (3 months);
You likely can't join if
- people with psychiatric disorders including schizophrenia, bipolar affective disorder, emotionally unstable personality disorder, schizoaffective...
- Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement;
- Subject has an infection at implant site;
- people at high risk of surgical complications, such as active systemic infection and hemorrhagic disease;
- Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant (cochlear implant(s));
- Subject has a profession or hobby that includes activity imposing an unacceptable risk for trauma to the device or implant site, e.g. martial arts or...
See the full eligibility criteria
- Age \> 12 years old, with or without intellectual disabilities;
- Diagnosis of drug resistant seizures, DEE or rare epilepsies ;
- One or more seizure types as established by previous epilepsy history thus allowing to define seizure type and scalp topography of the ictal discharge;
- Availability for the duration of the study (3 months);
- people with psychiatric disorders including schizophrenia, bipolar affective disorder, emotionally unstable personality disorder, schizoaffective disorder;
- Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement;
- Subject has an infection at implant site;
- people at high risk of surgical complications, such as active systemic infection and hemorrhagic disease;
- Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant (cochlear implant(s));
- Subject has a profession or hobby that includes activity imposing an unacceptable risk for trauma to the device or implant site, e.g. martial arts or boxing;
- Subject has a contraindication to the use of local anesthetic drugs used during implantation- and removal of the device;
- Subject is unable or does not have the necessary assistance to properly operate the device system.
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Roma, Italy, Italy
- Trieste, Italy, Italy
- Modena, Taly, Italy
- Naples, Taly, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, Italy, Italy; Trieste, Italy, Italy; Modena, Taly, Italy; Naples, Taly, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.