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NCT06705816 · ClinicalTrials.gov registry record
Cognitive Function in Rett Syndrome During Trofinetide Treatment
A clinical trial of Rett Syndrome, sponsored by University of Minnesota.
- Recruiting
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT06705816 is a study of Rett Syndrome that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 20 participants, below the 525-participant average among 18 other Rett Syndrome trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06705816, a study of Rett Syndrome, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- OTHER None interventional
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-12-01 |
| Est. Completion | 2026-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06705816
The ClinicalTrials.gov registry entry for NCT06705816 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 525-participant average among 18 other Rett Syndrome trials with a reported enrollment target (96% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Rett Syndrome appearing as the primary indexed condition, and to 1 intervention - of which None interventional is the first listed.
NCT06705816 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06705816 about?
NCT06705816 is a clinical study titled "Cognitive Function in Rett Syndrome During Trofinetide Treatment". 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...
What is the current status of trial NCT06705816?
This trial is currently recruiting. The enrollment target is 20 participants. The study started on 2024-12-01. Estimated completion is 2026-06.
What conditions does trial NCT06705816 study?
This clinical trial studies the following conditions: Rett Syndrome.
What interventions are being tested in trial NCT06705816?
The interventions under investigation include: None interventional (OTHER).
Who is sponsoring clinical trial NCT06705816?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06705816 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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