Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Not applicable

Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.

NCT04126369 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2020-01-20
Last updated
2024-05-08

Condition(s) studied

Drug Resistant Epilepsy

Investigational drug(s) / intervention(s)

mindfulness interventionpsycho educative programme

mindfulness intervention: The mindfulness program is conducted in a group session of up to 10 people. Each session lasts 2 hours. A total of 12 sessions will be conducted by a practitioner who is specifically trained in this type of programme.

psycho educative programme: The psycho-educational control intervention will follow the same format and structure as the mindfulness meditation intervention in terms of group format, session duration and frequency. This is a therapeutic education programme developed for several years in the neurology department of the university hospital of Lyon and Grenoble. The program follows the repository recommended by the french league against epilepsy.

Study summary

This study evaluates a mindfulness intervention in patients with drug resistant epilepsy.

Half of participants will follow a mindfulness programme, while the other half will follow a self management programme.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Drug resistant epilepsy according to the criteria of the International League Against Epilepsy (ILAE) * Stable therapy for at least 3 months * No planned surgery * Patient affiliated to social security insurance or beneficiary of social security insurance. * Signed consent Exclusion Criteria: * Patient who has previously had or regularly practicing mindfulness * Patient with psychogenic non-epileptic seizures * Pregnant woman, breastfeeding mother, person deprived of liberty by judicial or administrative decision, person subject to legal protection * Patient with relationship disorders related to psychosis * Patients who are unable or unwilling to work as a group or person unable to understand the topics discussed during session.

Primary outcome measure(s)

  • Evolution of Quality Of Life In Epilepsy-Problems questionnaire (QOLIE31-P) score. — 9 months
    The QOLIE31-P questionnaire has been developed specifically to measure the quality of life of patients with epilepsy. The score ranges from 0 to 100 points. Higher scores reflect better quality of life; lower ones, worse quality of life. The score of QOLIE31-P will be assess prior to intervention and then at month 3, month 6 and month 9 after the beginning of the intervention. Ref : Cramer JA. Van Hammee G. N132 Study Group. Maintenance of improvement in health-related quality of life during long-term treatment with levetiracetam. Epilepsy \& Behavior 2003; 4:118-123.

Trial sites (3)

FacilityCityRegionStatus
Epileptology Department of The Grenoble University Hospital Grenoble France Recruiting
Epileptology Department of the Lyon University Hospital Lyon France Not Yet Recruiting
La Teppe medical centre Tain-l'Hermitage France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04126369 on ClinicalTrials.gov ↗ ← All trials in France