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OpenTrials
Completed

NCT Number: NCT02227381

Action Medical Research

Learning disability affects 3% of the population. Severe types of learning disability are more likely to have an underlying genetic cause but diagnosis is difficult because many different genetic abnormalities may be involved. Obtaining a diagnosis is important so that patients can be managed appropriately and their families can be given accurate information.

We aim to use new types of genetic testing which will make it possible to screen for several different genetic abnormalities which cause learning disability at the same time, so improving the accuracy and speed of diagnosis in the group of patients with severe learning disability. We will focus particularly on patients where seizures and behavioural problems are also present.This will enable more patients to be diagnosed accurately, reduce the number of hospital appointments needed and ultimately be more cost- effective.

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Key information

Conditions

Learning Disabilities Communication Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Manchester University Hospitals NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with severe learning disability associated with either seizures, movement or behaviour problems who had previously undergone routine investigation but where no cause had been identified for their problems

Exclusion criteria

  • Individuals with SLD where the cause is already known
  • Individuals where informed consent cannot be obtained for participation

Treatment and study plan

Primary outcomes

  1. Genetic abnormality identified by microarray or Next Generation Sequencing

    Time frame: up to 6 months following consent

    Abnormalities identified upon results of testing, the normal timeframe for this is up to 6 months after collecting blood sample.

Secondary outcomes

  1. Cost effectiveness vs normal care

    Time frame: By the end of the study (December 2014)

    This analysis will be performed for all participants following close of recruitment & follow up, and will be completed by the time the study ends.

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Registry information

Official study title

Using New Genetic Technology to Diagnose Neurodevelopmental Disorders

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Aug 28, 2014
Registry last updated
Dec 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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