Posterior Fossa Mutism Clinical Trial
Official title:
Long-Term Impact of 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.
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. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Ann & Robert H Lurie Children's Hospital of Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Ann & Robert H Lurie Children's Hospital of Chicago |
United States,
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
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 |