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Register:	ClinicalTrials.gov
Last refreshed on:	25 May 2015
Main ID:	NCT02436746
Date of registration:	29/04/2015
Prospective Registration:	No
Primary sponsor:	Erasmus Medical Center
Public title:	The Cognitive Variability in NF1 and TSC Monozygotic Twins COVANTT
Scientific title:	The Cognitive Variability in Neurofibromatosis Type I and Tuberous Sclerosis Complex Monozygotic Twins
Date of first enrolment:	April 2015
Target sample size:	116
Recruitment status:	Recruiting
URL:	http://clinicaltrials.gov/show/NCT02436746
Study type:	Observational
Study design:	Observational Model: Cohort, Time Perspective: Cross-Sectional
Phase:	N/A

Countries of recruitment
Netherlands

Contacts

Name:	Ype Elgersma, Prof.
Address:
Telephone:	+31 10 7037739
Email:	y.elgersma@erasmusmc.nl
Affiliation:

Name:	Ype Elgersma, Prof.
Address:
Telephone:	+31 10 7037739
Email:	y.elgersma@erasmusmc.nl
Affiliation:

Name:	Ype Elgersma, Prof.
Address:
Telephone:
Email:
Affiliation:	Erasmus MC

Key inclusion & exclusion criteria

Inclusion Criteria:

- The participant is part of a monozygotic twin pair (which is genetically confirmed);

- NF1 or TSC patients with a genetically confirmed diagnosis;

- Oral and written informed consent by participant in case = 18 years of age.

- Oral and written informed consent by both caregivers and assent by participant in
case of minor participants.

Exclusion Criteria:

- A potential subject of whom the twin sibling is not willing or able to participate in
this study, will be excluded from participation in this study.

- Symptomatic brain pathology.

Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberous Sclerosis Complex

Neurofibromatosis Type I

Intervention(s)

Primary Outcome(s)

Correlation of full intelligence quotient [Time Frame: 1 day]

Secondary Outcome(s)

Correlation of attention problems [Time Frame: 1 day]

Correlation of behavioural problems [Time Frame: 1 day]

Correlation of autistic features [Time Frame: 1 day]

Correlation of word reading ability [Time Frame: 1 day]

Correlation of executive control (TSC twins only) [Time Frame: 1 day]

Correlation of visuospatial judgement (NF1 twins only) [Time Frame: 1 day]

Secondary ID(s)

MEC-2014-483

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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