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Completed

NCT Number: NCT02048176

Posterior Fossa Mutism on Quality of Life

Posterior fossa mutism (PFM) occurs in up to 30% of patients after resection of a posterior fossa tumor, most commonly a medulloblastoma. PFM is characterized by delayed onset of mutism 1-6 days after surgery that can spontaneously improve on average from 7-8 weeks later. Few patients recover normal speech. Most of their speech continues to be marked by dysarthria, dysfluency and slowed rate. Researchers have not identified the pathophysiologic mechanism for PFM nor have they found a cure. Despite the improvements in speech, patients with PFM have shown multiple areas of neurocognitive deficits 12 months after diagnosis. Few studies have looked at long term outcomes of patients affected by PFM. We propose to survey patients who developed PFM after resection of a medulloblastoma to determine long term effects of PFM on patient's quality of life.

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Key information

Conditions

Posterior Fossa Mutism Communication Disorders Language Disorders Mental Disorders Mutism Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders

Age range

8 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must be between 8 years and 25 years of age at the time of enrollment and have completed treatment for their initial diagnosis of medulloblastoma.

Exclusion criteria

  • Patient is less than 8 years old or greater than 25 years old at the time of the administration of the survey.
  • Patients are too ill to complete the survey as identified by their treating physician.
  • Patients who are unable to speak or understand English.
  • Patients who are currently being treated for their original diagnosis of medulloblastoma.

Treatment and study plan

Primary outcomes

  1. Quality of Life

    Time frame: Thirty minutes, no follow-up.

Secondary outcomes

  1. quality of life in terms of anger, anxiety, depression, fatigue, social functioning, pain and stigma

    Time frame: 30 minutes, no follow-up

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

Long-Term Impact of Posterior Fossa Mutism on Quality of Life

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 29, 2014
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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