Action Medical Research

Learning Disabilities Clinical Trial

Official title:

Using New Genetic Technology to Diagnose Neurodevelopmental Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227381
• Other study ID #: 10/H1003/98
• Secondary ID: SP4555
• Status: Completed
• Start date: February 2011
• Est. completion date: June 2015

Study information

• Verified date: November 2018
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: June 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Learning Disabilities
• Learning Disorders
• Neurodevelopmental Disorders

Locations

Country	Name	City	State
United Kingdom	Central Manchester University Hospitals NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic abnormality identified by microarray or Next Generation Sequencing	Abnormalities identified upon results of testing, the normal timeframe for this is up to 6 months after collecting blood sample.	up to 6 months following consent
Secondary	Cost effectiveness vs normal care	This analysis will be performed for all participants following close of recruitment & follow up, and will be completed by the time the study ends.	By the end of the study (December 2014)