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EpilepsyPRECISIONNCT05182437

Precision Radiation Treatment for Epilepsy (PRECISION)

A study testing LINAC-based Stereotactic Radiotherapy in people with Epilepsy, run by Maastricht Radiation Oncology at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The PRECISION-study offers a non-invasive, curative intervention for drug-resistant localised epilepsy patients who are not eligible for surgery. The intervention will consist of a single LINAC based SRT treatment and is given by the radiation-oncologist after detailed localisation of the epileptogenic zone with the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Epilepsy
What is being tested?
LINAC-based Stereotactic Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteNetherlands
Study dates
1 Dec 2023to 1 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
  • Willingness to use contraception by a method that is deemed effective by the Investigator during the SRT treatment and for at least 30 days following the SRT therapy
  • The patient or caretaker is able to keep an epilepsy diary
  • The patient has a diagnosis of epilepsy established by a dedicated neurologist
  • The patient had at least 3 focal-onset seizures over a 3-month period despite two or more antiepileptic medication trials (according ILAE Task Force on therapeutic strategies)
Show all 12Show fewer
  • Video electroencephalography and work-up in the epilepsy surgery working group to determine a well-circumscribed seizure focus is available
  • Evidence (e.g. 3T-MRI or a clear SEEG delineation) of the anatomic region to be targeted with SRT, correlating with the EZ hypothesis;
  • A functional MRI to lateralize language or localize visual, motor and/or sensory eloquent cortex has been performed in selected patients (if the lesion is expected to be located, based on anatomy, in the language areas).
  • The patient has completed a standard battery of neuropsychological testing
  • The patient been deemed an appropriate candidate for stereotactic radiosurgery by a dedicated Radiation Oncologist and Neurosurgeon/Epileptologist and referred for the study by one of the Dutch regional multidisciplinary epilepsy surgery working groups
  • Patients that were rejected for surgery in an earlier stage can participate in the trial if the last change of the NVS/DBS settings were more than 1 year ago or NVS/DBS was not (yet) tried.

Who cannot join

  • Pregnancy
  • If a radiation treatment plan without exceeding the constraints for the organs at risk is not feasible.
  • Prior cranial radiotherapy
  • If radiotherapy treatment is not possible for diverse reasons.
  • If the subject has clinically significant and uncontrolled major other medical condition(s) including but not limited to:
  • psychiatric illness/social situation that would limit compliance with study requirements iii. any medical condition, with the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities iv. Progressive co-morbidity which limits overall survival.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht Radiation Oncology

    Maastricht, Limburg, 6202 AZ

Other trials in Netherlands

About this study

The PRECISION-study offers a non-invasive, curative intervention for drug-resistant localised epilepsy patients who are not eligible for surgery. The intervention will consist of a single LINAC based SRT treatment and is given by the radiation-oncologist after detailed localisation of the epileptogenic zone with the neurologist, radiologist and neurosurgeon.

This intervention will make curative-intent treatment possible where this could otherwise not be given and is a non-invasive and non-competitive alternative to epilepsy surgery. It is expected that the health costs for this curative treatment will not exceed standard treatment, such as lifelong medication and neuromodulation.

Read the detailed description

In this PRECISION-study including adult patients with drug-resistant, localised epilepsy, not eligible for surgery, we offer non-invasive linear accelerator (LINAC) based Stereotactic Radiotherapy (SRT) with curative intent.

SRT and stereotactic radio-surgery (SRS) have been used to treat several types of neoplasms in the brain for several decades. Several publications (level 2 evidence) have shown the potential value of SRT in patients with drug-resistant epilepsy, however no level-1 evidence was given enabling guideline development. A recent systematic review from our institution has shown that SRT resulted in a significant seizure cure or reduction in 58% of the 170 included patients, within 2 years after treatment. Interestingly, the ROSE trial, randomising between open surgery and SRT, has demonstrated a seizure remission of 52% in the radiotherapy group after 2 years with the proportion of seizure-free patients still increasing with a longer follow-up up to 74% after 3 years. Therefore, SRT may be considered a curative treatment for drug resistant localised epilepsy. Currently, randomized controlled SRT epilepsy trials are lacking and there is a need for high quality evidence, so SRT can be clinically implemented for localised drug-resistant epilepsy patients in the Netherlands as well.

The PRECISION-study is a randomised waitlist-controlled trial in which SRT is the intervention and AED continuation and neuromodulation are the standard treatment with a 1:1 randomization. After 2-year follow up the waitlist-control group, patients are offered the intervention (optional).

We hypothesize that SRT alters the epileptogenic cerebral tissue to yield a reduction in seizures and possibly cure after 2 years, with a significant increase in the patients' quality of life.

Conditions
Epilepsy
Being tested
LINAC-based Stereotactic Radiotherapy
Medical subject headings
Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LINAC-based Stereotactic RadiotherapyRadiation

    Target definition: the target volume is defined as the epileptogenic zone (EZ) on all (non) invasive examinations (e.g. 3, 7 Tesla MRI or Stereo-EEG) of the presurgical path. Planning target volume (PTV) = GTV. A single fraction SRT with a prescribed isotoxic dose of 24 Gy to the 100% surrounding isodose. Dose is depending on the proximity and maximum tolerable dose to the radiosensitive organs at risk and EZ volume resulting in a V12<= 10 cc reducing the risk on radionecrosis.

Study groups in NCT05182437
Study groupRoleWhat they receive
LINAC-based Stereotactic RadiotherapyExperimentalThe intervention will consist of a single LINAC based SRT treatment and is given by the radiation-oncologist after detailed localisation of the epileptogenic zone (EZ) with the neurologist, radiologist and neurosurgeon.
Receives: Radiation: LINAC-based Stereotactic Radiotherapy
Randomised waitlist-controlled trialOtherThe first 2 years after randomization stardard treatment (AED continuation and neuromodulation). After 2-year follow up the waitlist-control group, patients are offered the intervention (LINAC-based Stereotactic Radiotherapy). This intervention is optional
Receives: Radiation: LINAC-based Stereotactic Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiotherapy adapted Engel classification (RAEC) is I, II or III

    Radiotherapy adapted Engel classification (RAEC). For analysis of outcomes in the incidence of seizures, we use in this study the Engel classification, adapted for radiotherapy. This includes four classes: class I - seizure free, class II - rarely seizures, class III improved, more than 75% IV- no significant improvement.

    Measured: Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

Secondary outcomes (10)

  1. Seizure frequency

    self-reports and reports from caretakers, combined in a digital diary.

    Measured: Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

  2. Seizure-free days

    self-reports and reports from caretakers, combined in a digital diary.

    Measured: Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

  3. Type of epilepsy

    self-reports and reports from caretakers, combined in a digital diary.

    Measured: Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

  4. EQ-5D 5 Level (EQ-5D-5L)

    EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one. There are 5 questions and 5 qualitative answers plus a numerical scale (from 0 to 100) related with the general health status. We will attribute a numerical value to the 5 qualitative answers (100 for the best/ 75, 50, 25 and 0 for the worse).

    Measured: Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

  5. The Assessment of Quality of Life-8 Dimensions Score (AQoL-8D Score)

    The Assessment of Quality of Life (AQoL) measure of health-related Quality of Life. AQoL-8D covers dimensions of Independent Living, Happiness, Mental Health Coping, Relationships, Self-Worth, Pain, and Senses. Items are scored from 0 to 3. Scores range from 0 to 45 with higher scores indicating poorer quality of life

    Measured: Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

  6. Quality of life in Epilepsy-31 Inventory (QOLIE-31)

    The QOLIE includes 31 questions about health and daily activities. Responses are given on a range of scales. Responses are coded to 0 to 100 point scales where higher scores indicate better quality of life. The final score is the average of scores for the individual items.

    QOLIE-31 is a widely used epilepsy-specific questionnaire

    Measured: Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

  7. 'Cost-effectiveness Resource use' is measured with iMTA Productivity Cost Questionnaire (iPCQ)

    Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ). The iPCQ is a standardized instrument for measuring and valuing health related productivity losses. This wil be used for the cost effectiveness analysis.

    Measured: Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

  8. 'Cost-effectiveness Resource use' is measured with iMTA Medical Consumption Questionnaire (iMCQ)

    Institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ). The iMCQ is a standardized instrument for measuring medical costs.

    The aim of the iVICQ is to facilitate and promote an accurate description of providing informal care, its effects on informal caregivers, and how such effects are included in economic evaluations of health care interventions.

    Measured: Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

  9. 'Informal care' is meausured with iMTA Valuation of Informal Care Questionnaire (iVICQ)

    Institute for Medical Technology Assessment (iMTA) Valuation of Informal Care Questionnaire (iVICQ).

    The aim of this standardized instrument is to facilitate and promote an accurate description of providing informal care, its effects on informal caregivers, and how such effects are included in economic evaluations of health care interventions.

    Measured: Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

  10. 'Patients' experiences' are measured with the instrument 'Patient Reported Experience Measures Medical Specialtic Care' (PREM MSZ) Medical Specialistic Care (PREM MSZ)

    PREM MSZ is a Dutch standardized questionnaire to report Patient Reported Experience. Instrument is developed by NIVEL (Dutch Institute for Healthcare Research) in collabaration with Dutch healcare insurers. Instrument includes 13 questions about the satisfaction with the communication between the patient and the caregiver, shared decision making, trust in the expertise of the physician, the effect of the treatment. Responses to these questions are coded into 0 to 10 points. Higher scores indicate higher satisfaction with care. In the questionnaire patients are also asked for the evaluation of their own health, recommendations to improve care, and if they would recommend the care to other patients with the same health problem. Finally there are some questions about background variables (age, gender, education)

    Measured: Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2022
  2. Study start1 Dec 2023
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial Observational Model : Experimental Time Perspective : Prospective
Masking
None (open label)
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05182437
Sponsor's protocol ID
80-86200-98- 25008
Acronym
PRECISION
Status last verified
May 2025
First submitted
27 Sep 2021
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eekers DBP, Pijnappel EN, Schijns OEMG, Colon A, Hoeben A, Zindler JD, Postma AA, Hoffmann AL, Lambin P, Troost EGC. Evidence on the efficacy of primary radiosurgery or stereotactic radiotherapy for drug-resistant non-neoplastic focal epilepsy in adults: A systematic review. Seizure. 2018 Feb;55:83-92. doi: 10.1016/j.seizure.2018.01.009. Epub 2018 Jan 31.

    PubMed 29414140

  • Zegers CML, Swinnen A, Roumen C, Hoffmann AL, Troost EGC, van Asch CJJ, Brandts L, Compter I, Dieleman EMT, Dijkstra JB, Granzier M, Hendriks M, Hofman P, Houben RMA, Ramaekers B, Ronner HE, Rouhl RPW, van der Salm S, Santegoeds RGC, Verhoeff JJ, Wagner GL, Zwemmer J, Schijns O, Colon AJ, Eekers DBP. High-precision stereotactic irradiation for focal drug-resistant epilepsy versus standard treatment: a randomized waitlist-controlled trial (the PRECISION trial). Trials. 2024 May 21;25(1):334. doi: 10.1186/s13063-024-08168-9.

    PubMed 38773643

Questions about this trial

What is this clinical trial studying?

A study testing LINAC-based Stereotactic Radiotherapy in people with Epilepsy, run by Maastricht Radiation Oncology at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiotherapy adapted Engel classification (RAEC) is I, II or III (time frame: Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05182437, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.

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