University of Minnesota
Minneapolis, Minnesota, 55414, United States
Location status: Recruiting
Location contact
Breanne Byiers
CONTACT
NCT Number: NCT06705816
Assessing cognitive functions among individuals with severe intellectual and developmental disabilities (IDD), including RTT, is often challenging due to floor effects of many standardized assessment batteries in this population. In addition, deficits in motor function and verbal ability may obscure certain abilities in this population when using standard IQ measures. Remote eye-tracking tasks have been proposed as an alternative approach for assessing cognitive functions among individuals with severe IDD, because eye-tracking tasks can be designed to minimize the influence of gross motor and receptive language deficits on performance. Although several types of eye-tracking tasks have been evaluated in RTT, most have been implemented only at a single time-point. As a result, it is unclear whether these measures are stable over time, or sensitive to developmental changes or alterations to health status that occur in RTT (e.g., developmental regression, development of seizures, change in medication, etc.). With the recent FDA approval of trofinetide for the treatment of RTT, we have a novel opportunity to test the sensitivity of eye-tracking and other psychophysiological measures to treatment changes. Anecdotally, parents and clinicians have reported improvements in attention and alertness during trofinetide treatment, but currently available outcome measures do not capture these types of effects. Therefore, we propose to conduct a pilot trial of changes in measures of attention, oculomotor function, learning, and autonomic function, all collected using non-invasive measures, during trofinetide treatment. This is an observational within-subject design with a 4-week post-treatment assessment compared to two pre-treatment assessments. Additional optional follow-up assessments will be performed with families who are interested and returning for standard-of-care visits to Gillette or who are willing to travel for a research-only visit.
Interested in participating?
Request Info18 year–99 year
All sexes
Observational
Minneapolis, Minnesota, 55414, United States
Location status: Recruiting
Breanne Byiers
CONTACT
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is an observational study
Time frame: baseline, 6weeks to 12 months
change in saccade latencies during the 'statistical learning' paradigm
Time frame: baseline, 6weeks to 12 months
change in duration of gaze fixation to the correct image during the 'Looking While Listening' paradigm.
Time frame: baseline, 6weeks to 12 months
Change in baseline heart rate variability during sustained attention during eye-tracking tasks.
Time frame: baseline, 6weeks to 12 months
Change in baseline heart rate suppression during sustained attention during eye-tracking tasks.
Contact information is provided by the study sponsor or research team.
University of Minnesota
Other
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