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Finding clinical endpoints in patients with ARID1B-related intellectual disability

Finding suitable clinical endpoints for ARID1B-related intellectual disability

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25725
Enrollment
24
Registered
2018-10-22
Start date
2018-11-14
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARID1B

Interventions

N.A.

Sponsors

Centre for Human Drug Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ARID1B group • Informed consent provided by both parents or the legal guardian prior to any study-mandated procedure. • Known mutation in ARID1B. Healthy control subjects • Informed consent provided by both parents or the legal guardian if aged 11 years or younger. • Informed consent provided by both parents or the legal guardian, and the participant if aged 12 up and till 15 years. • Informed consent provided by the participant if aged 16 years or older.

Exclusion criteria

Exclusion criteria: • Clear indication of not wanting to participate during the study • Use of benzodiazepines or any other medication with the potential to influence study related endpoints in the investigator’s opinion.

Design outcomes

Primary

MeasureTime frame
Safety and tolerability endpoints (serious) adverse events ((S)AEs). End-of-study questionnaire Neurocart® assessments Saccadic eye movements: osaccadic reaction time (second), osaccadic peak velocity (degrees/second) Smooth pursuit eye movements: opercentage of time the eyes of the subjects are in smooth pursuit of the target (%); Body sway: oantero-posterior sway (mm); Adaptive tracking: o average performance (%); Finger tapping: o Mean of 5 tapping-trials for the dominant hand Auditory steady state response oThe average inter-trial phase coherence between 35 and 45 Hz and between 200 and 500 ms. oThe average evoked power between 35 and 45 Hz and between 200 and 500 ms. Visual evoked potentials oThe N75 amplitude [µV] oThe P100 amplitude [µV] oThe peak to peak amplitude between the N75 and P100 [µV] oThe latency of the N75 peak [ms] oThe latency of the P100 peak [ms] Passive auditory oddball oThe average MMN amplitude at Fz [µV] oThe average MMN latency at Fz [ms] oThe average MMN amplitude at Cz [µV] oThe average MMN latency Cz [ms] Active auditory oddball oThe average response time to deviant stimuli [ms] oThe average P300 amplitude at Fz [µV] oThe average P300 latency at Fz [ms] oThe average P300 amplitude at Cz [µV] oThe average P300 latency Cz [ms] oThe average P300 amplitude at Pz [µV] oThe average P300 latency Pz [ms] Animal fluency test oTotal number of uniquely named animals Stroop-like day-night task oNumber of correct responses in incongruent trials 15-word Visual Verbal Learning Test oDelayed word recognition number correct oDelayed word recognition average reaction time correct oDelayed word recall number correct oImmediate Word Recall, number correct, first trial oImmediate Word Recall, number correct, second trial oImmediate Word Recall, number correct, third trial Nokia Steel HR

Contacts

Public ContactCHDR

Zernikedreef 8

+31 071-5246400

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)