Minneapolis, MNNCT06705816Now EnrollingIRB Ready

Rett Syndrome Clinical Trial in Minneapolis, MN

Access cutting-edge rett syndrome treatment through this clinical trial at a research site in Minneapolis. Study-provided care at no cost to qualified participants.

Sponsored by University of Minnesota

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Expert Care in Minneapolis

Access rett syndrome specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related rett syndrome treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Minneapolis

    Convenient for MN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Minneapolis site if eligible
  4. 4Begin participation

About This Rett Syndrome Study in Minneapolis

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.

Sponsor: University of Minnesota

Who Can Participate

Inclusion Criteria

Any individuals who are initiating trofinetide treatment for RTT through the physicians associated with the Gillette Children's RTT clinic will be potentially eligible for participation, regardless of age. To enroll, participants must meet the following criteria:
Provision of signed and dated informed consent form by the individual\'s parent/legal guardian
Stated willingness to comply with all study procedures and availability for the duration of the study
Documented diagnosis of Rett syndrome
Participant is not showing active signs of developmental regression, defined as: no loss or degradation of ambulation within the past 6 months; no loss or degradation of hand function within the past 6 months; and no loss or degradation of verbal or non-verbal communication or social skills in the past 6 months.
Participant's current pharmacological treatment regimen has been stable for at least 4 weeks.
Seeking prescription for trofinetide through the Gillette Children's Rett syndrome clinic

Exclusion Criteria

Diagnosis of a progressive medical or neurological condition that in the opinion of the investigator would interfere with the conduct of the study.
Current clinically significant systemic illness that is likely to result in the deterioration of the participant\'s condition during the study.
Participants taking any other investigational drug currently or within the past 30 days.
Known, uncorrected visual impairment that would limit the ability to view images during eye-tracking tasks.
Severe behavioral problems (i.e., aggression, property destruction, extreme hyperactivity) that would interfere with participation in study activities.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Minneapolis?

Yes, this clinical trial (NCT06705816) has an active research site in Minneapolis, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Rett Syndrome Treatment Options in Minneapolis, MN

If you're searching for rett syndrome treatment options in Minneapolis, MN, this clinical trial (NCT06705816) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Minneapolis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced rett syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all rett syndrome clinical trials near you to find additional studies recruiting in your area.

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