205 Participants Needed

Mapping the Genotype, Phenotype, and Natural History of Phelan-McDermid Syndrome

Recruiting at 4 trial locations
RF
Overseen ByRajna Filip-Dhima, MS
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this study is to comprehensively characterize PMS using standardized medical, cognitive, and behavioral measures and to track the natural history of the syndrome using repeated longitudinal assessments. In addition, this study will be aiming to identify biomarkers using neuroimaging, including diffusion tensor imaging and identify genetic factors which contribute to diverse phenotypes in patients with PMS.

Research Team

AK

Alexander Kolevzon, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

Inclusion Criteria

Individuals older than 18 months of age with pathogenic deletions or mutations of the SHANK3 gene
English speaking individuals

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments including physical exam, medical history, blood work, and neuropsychological assessments

1 visit
1 visit (in-person)

Longitudinal Assessment

Participants undergo repeated assessments to track changes in autism symptoms, language abilities, motor functioning, adaptive behavior, and cognitive ability

24 months
3 visits (in-person) over 2 years

Follow-up

Participants are monitored for safety and effectiveness after the main assessments

4 weeks

Treatment Details

Interventions

  • N/A

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials
394
Recruited
404,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Office of Rare Diseases (ORD)

Collaborator

Trials
44
Recruited
12,400+

Phelan-McDermid Syndrome Foundation

Collaborator

Trials
3
Recruited
4,600+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Center for Advancing Translational Science (NCATS)

Collaborator

Trials
100
Recruited
32,100+
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