Creating a database for people with intellectual disabilities and epilepsy

Neuropsychiatric Research Databases for People With Intellectual Disabilities and Epilepsy (REFINE)

This study is trying to create a secure database of medical information about people with intellectual disabilities and epilepsy to help improve their treatment and support future research.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Plymouth (Academic / other)
• Locations: 3 sites (Bodmin and 2 other locations)
• Trial ID: NCT06780501 on ClinicalTrials.gov

What this trial studies

This study aims to establish a de-identified research database that collects medical information about individuals with intellectual disabilities and epilepsy from three NHS sites in England and Wales. The first part focuses on gathering clinical details, epilepsy history, and medication data while ensuring participant anonymity. The second part involves creating a research register of eligible individuals who can provide consent, which will help facilitate future studies. The overall goal is to improve understanding and treatment options for this population.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with a clinical diagnosis of intellectual disability and epilepsy who are currently under specialist care.

Not a fit: Patients with other neurodevelopmental disorders without intellectual disabilities or those who have opted out of data sharing for research will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of epilepsy and intellectual disabilities, leading to better-targeted treatments and interventions.

How similar studies have performed: While this approach is observational and builds on existing data collection methods, similar studies have shown success in enhancing understanding of complex conditions like epilepsy and intellectual disabilities.

Eligibility criteria

The de-identified database:

Inclusion Criteria:

* Clinical diagnosis of ID in medical records.
* Clinical diagnosis of epilepsy in medical records.
* Patient is over the age of 18 years old.
* Under the current care of specialist ID or epilepsy services at one of the three participating NHS Trusts.

Exclusion Criteria:

* Other neurodevelopmental disorders without ID.
* Patient is recorded on the National Data Opt-out as not wishing their data to be used for research/audit.

The research register:

Inclusion Criteria:

* Clinical diagnosis of ID in medical records.
* Clinical diagnosis of epilepsy in medical records.
* Under the current care of specialist ID or epilepsy services at one of the three participating NHS Trusts.
* Between the ages of 18 and 30 at the time of consent.
* Participant has the capacity to be able to provide consent for themselves, or a personal consultee is able to provide an opinion on the views and feelings of the potential participant.
* Patients (or personal consultee) must be able to communicate in English (or Welsh in Welsh site).

Exclusion Criteria:

\- Other neurodevelopmental disorders without ID.

Where this trial is running

Bodmin and 2 other locations

• Cornwall Partnership NHS Foundation Trust — Bodmin, United Kingdom (Recruiting)
• Royal Free London Hospitals NHS Trust — London, United Kingdom (Not_yet_recruiting)
• Swansea Bay University Health Board — Swansea, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Lance Watkins — Swansea Bay University Health Board
• Study coordinator: Rohit Shankar

Conditions Epilepsy; Intellectual Disability; Learning Disability