NeuralNET Cerebral Palsy Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-14

Study Completion Date

2026-01-31

Brief Summary

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The NeuralNET Cerebral Palsy Pilot Study is testing a genetic testing pathway in the NHS for children with cerebral palsy (CP). Other studies suggest that almost one in three peoples' CP is caused by a change in their genes, but more studies are needed to confirm this. A genetic test called whole genome sequencing (WGS) will be used for children who have CP to look for rare changes in genes that cause the condition, and the results of the test will be given to children's doctors within 12 weeks. Knowing that CP has a genetic cause could lead to changes being made to a child's care or treatment that could improve their condition.

The study will test 66 children with CP from 3 hospitals, and also their biological parent(s), if they're available. Following informed consent, the investigators will collect a blood sample from everyone taking part which will be sent for WGS. It is important to understand what families think and feel about the testing. The investigators will ask parents/guardians of the children taking part to fill in two questionnaires, one before and one after WGS. Some parents/guardians will also be interviewed after getting the WGS result, to ask about their experience of the testing. The study will take up to 16 months per family.

The results of this pilot study will tell the investigators if it is feasible for the NHS to use WGS to test children with CP. If so, a larger study testing more children with CP can then be carried out to help decide if this type of WGS-based testing should be made available through the NHS to children with CP whose clinical care might be changed by the result. The genetic findings from this study will also be made available to other researchers and doctors to do more research into CP that might help improve general understanding of the condition and its potential treatment.

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Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Whole-genome sequencing

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

Children with cerebral palsy (CP):

1. Has a clinical diagnosis of CP in the medical record
2. Any GMFCS score (GMFCS 1-5)
3. Does not have a known genetic diagnosis that explains the CP phenotype
4. Has a parent/legal guardian available who can consent and is willing to complete study questionnaires
5. Invited to participate by a clinician at a participating recruitment site

Biological parents of children with CP will also be included in the study if they are:

1. A biological parent of the child
2. Aged 18 years or above
3. Willing and able to give informed consent for participation in the study Participant type

1. A biological parent of the child
2. Aged 18 years or above
3. Willing and able to give informed consent for participation in the study