Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02048176
Other study ID # 2011-14721
Secondary ID
Status Completed
Phase N/A
First received January 27, 2014
Last updated February 3, 2016
Start date July 2011
Est. completion date March 2012

Study information

Verified date February 2016
Source Ann & Robert H Lurie Children's Hospital of Chicago
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 25 Years
Eligibility 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:

1. Patient is less than 8 years old or greater than 25 years old at the time of the administration of the survey.

2. Patients are too ill to complete the survey as identified by their treating physician.

3. Patients who are unable to speak or understand English.

4. Patients who are currently being treated for their original diagnosis of medulloblastoma.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Ann & Robert H Lurie Children's Hospital of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (7)

Gudrunardottir T, Sehested A, Juhler M, Schmiegelow K. Cerebellar mutism: review of the literature. Childs Nerv Syst. 2011 Mar;27(3):355-63. doi: 10.1007/s00381-010-1328-2. Review. — View Citation

Küpeli S, Yalçin B, Bilginer B, Akalan N, Haksal P, Büyükpamukçu M. Posterior fossa syndrome after posterior fossa surgery in children with brain tumors. Pediatr Blood Cancer. 2011 Feb;56(2):206-10. doi: 10.1002/pbc.22730. Epub 2010 Oct 25. — View Citation

Ozgur BM, Berberian J, Aryan HE, Meltzer HS, Levy ML. The pathophysiologic mechanism of cerebellar mutism. Surg Neurol. 2006 Jul;66(1):18-25. Review. — View Citation

Palmer SL, Hassall T, Evankovich K, Mabbott DJ, Bonner M, Deluca C, Cohn R, Fisher MJ, Morris EB, Broniscer A, Gajjar A. Neurocognitive outcome 12 months following cerebellar mutism syndrome in pediatric patients with medulloblastoma. Neuro Oncol. 2010 Dec;12(12):1311-7. doi: 10.1093/neuonc/noq094. Epub 2010 Aug 16. — View Citation

Robertson PL, Muraszko KM, Holmes EJ, Sposto R, Packer RJ, Gajjar A, Dias MS, Allen JC; Children's Oncology Group. Incidence and severity of postoperative cerebellar mutism syndrome in children with medulloblastoma: a prospective study by the Children's Oncology Group. J Neurosurg. 2006 Dec;105(6 Suppl):444-51. — View Citation

Szathmari A, Thiesse P, Galand-desmé S, Mottolese C, Bret P, Jouanneau E, Guyotat J, Lion-François L, Frappaz D. Correlation between pre- or postoperative MRI findings and cerebellar sequelae in patients with medulloblastomas. Pediatr Blood Cancer. 2010 Dec 15;55(7):1310-6. doi: 10.1002/pbc.22802. — View Citation

Wells EM, Walsh KS, Khademian ZP, Keating RF, Packer RJ. The cerebellar mutism syndrome and its relation to cerebellar cognitive function and the cerebellar cognitive affective disorder. Dev Disabil Res Rev. 2008;14(3):221-8. doi: 10.1002/ddrr.25. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life Thirty minutes, no follow-up. No
Secondary quality of life in terms of anger, anxiety, depression, fatigue, social functioning, pain and stigma 30 minutes, no follow-up No