Bumetanide to Ameliorate Tuberous Sclerosis Complex Hyperexcitable Behaviors
- Conditions
- Tuberous Sclerosis Complex (TSC)
- Registration Number
- NL-OMON26926
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
General inclusion criteria:
1. Males and females aged 8-15 years
Exclusion Criteria
1. Inability to comply with the protocol-specified procedures
2. Presence of a severe medical or genetic disorder other than related to TSC or epilepsy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Aberrant Behavior Checklist (ABC) irritability subscale
- Secondary Outcome Measures
Name Time Method Questionnaires<br /><br>- PedsQL<br /><br>- WHOQOL-BREF, EQ-5D-5L and EQ5D-Youth<br /><br>- TRF, BRIEF<br /><br>- ABC subscales<br /><br>- RBS-V<br /><br>- SRS<br /><br>- SP-NL and SP-SC<br /><br>- TAND<br /><br>Neurocognitive measurements <br /><br>- Cognitive test battery<br /><br>Epilepsy related variables<br /><br>- Seizure frequency<br /><br>- Number of occasions rescue medication is necessary<br>Electroencephalography<br /><br>- Resting state EEG and ERP assessments<br /><br>