A randomised control trial of SEEG electrode placement methods

Single-blinded randomised case control parallel group single-site investigation of stereoencephalography electrode placement in patients with refractory focal epilepsy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17209025

Enrollment

Registered

2016-11-15

Start date

2017-02-01

Completion date

Unknown

Last updated

2022-10-24

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

Conditions

Drug resistant focal epilepsy Nervous System Diseases Drug resistant focal epilepsy

Interventions

Patients who are scheduled for SEEG implantation as part of their routince medical care will be invited to take part in the study and are randomised by an independent statistician through the use of a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18-80 years 2. Drug refractory focal epilepsy 3. Deemed to require SEEG placement as part of routine clinical care following multidisciplinary team meeting decision 4. Informed consent from patient to undergo intracranial SEEG investigation as part of routine clinical care

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Uncorrectable coagulopathy 3. Lacking capacity to consent

Design outcomes

Primary

Measure	Time frame
Surgical implantation time will be measured in minutes and seconds during surgery.	—

Secondary

Measure	Time frame
1. Accuracy of SEEG depth electrode placement, as assessed by skull entry point (mm), error of angle (degrees) of implantation of intracranial bolt and target point error (mm) of the actual electrode tip compared to the planned target point as defined by the preoperative plan and target region sampled, as lateral deviation measured by the research team from the CT/MRI scan following surgery 2. Incidence of clinically significant and non-clinically significant radiologically detected post-operative haemorrhages (%) is measured using post-operative imaging within 48 hours of implantation 3. Infection rate (%) is measured by the presence or absence of infection on clinical observation and corroborated by blood test markers of infection such as white cell count and C-reactive protein as appropriate by the clinical team at routine follow up or medical note review if the patient asks medical assessment prior to the routine follow up period. 4. New post-operative neurological deficits (%) are measured by the presence or absence of a new neurological deficit on clinical observation by clinical team at routine follow up 5. Operator (surgeon) based opinions for ease of use and perceived safety of the iSYS1 trajectory guidance system compared to conventional mechanical arm based insertion is measured by documenting comments at the end of each operation on the electronic clinical research form (eCRF). 6. Proportion of patients that are offered resective surgery and seizure freedom following resective surgery (if performed) is measured by medical note review at routine follow up 7. Number and nature of adverse events is measured by the medical note review by the clinical team at routine follow up	—

Measure

Time frame

1. Accuracy of SEEG depth electrode placement, as assessed by skull entry point (mm), error of angle (degrees) of implantation of intracranial bolt and target point error (mm) of the actual electrode tip compared to the planned target point as defined by the preoperative plan and target region sampled, as lateral deviation measured by the research team from the CT/MRI scan following surgery 2. Incidence of clinically significant and non-clinically significant radiologically detected post-operative haemorrhages (%) is measured using post-operative imaging within 48 hours of implantation 3. Infection rate (%) is measured by the presence or absence of infection on clinical observation and corroborated by blood test markers of infection such as white cell count and C-reactive protein as appropriate by the clinical team at routine follow up or medical note review if the patient asks medical assessment prior to the routine follow up period. 4. New post-operative neurological deficits (%) are measured by the presence or absence of a new neurological deficit on clinical observation by clinical team at routine follow up 5. Operator (surgeon) based opinions for ease of use and perceived safety of the iSYS1 trajectory guidance system compared to conventional mechanical arm based insertion is measured by documenting comments at the end of each operation on the electronic clinical research form (eCRF). 6. Proportion of patients that are offered resective surgery and seizure freedom following resective surgery (if performed) is measured by medical note review at routine follow up 7. Number and nature of adverse events is measured by the medical note review by the clinical team at routine follow up

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 14, 2026