Effects of radiofrequency thermoCOagulation on brain NeTwork ACTivity in patients with epilepsy (CONTACT-study)

Effects of radiofrequency thermoCOagulation on brain NeTwork ACTivity in patients with epilepsy (CONTACT-study) - CONTACT-study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53677

Enrollment

Registered

2023-04-03

Start date

2023-08-30

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

convulsions Epilepsy Seizures

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients (age >=18 years) with DRE under presurgical evaluation for epilepsy surgery through SEEG potentially eligible for RFTC treatment patients able to give informed consent

Exclusion criteria

Exclusion criteria: -Patients who cannot meet the mild physical or psychological criteria for prolonged MRI recording -Pacemaker, VNS, DBS, and other MRI incompatible metal implants -Pregnancy

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the post-treatment seizure outcome (ILAE-classification)26 at 12 months post-RFTC. Interim measurements include seizure outcome at 3 and 6 months post-RFTC. Seizure outcome is determined by the treating physician at set interval at the outpatient clinic.	—

Secondary

Measure	Time frame
Secondary endpoints will be (in order of secondary research questions): 1. Same as primary/main parameter/endpoint 2. SEEG findings comprising baseline recordings, seizure recordings, stimulations at 1 Hz pre- and post-RFTC. Data is recorded during the inpatient admission by the treating physician. 3. Neurological outcomes between 6 to 12 months post-RFTC determined by the treating physician through neurological examination and neuropsychological outcomes between 6 to 12 months by using standardized tests.	—

Measure

Time frame

Secondary endpoints will be (in order of secondary research questions): 1. Same as primary/main parameter/endpoint 2. SEEG findings comprising baseline recordings, seizure recordings, stimulations at 1 Hz pre- and post-RFTC. Data is recorded during the inpatient admission by the treating physician. 3. Neurological outcomes between 6 to 12 months post-RFTC determined by the treating physician through neurological examination and neuropsychological outcomes between 6 to 12 months by using standardized tests.

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Countries

Netherlands

Outcome results