Posterior Fossa MutismNCT02048176
Posterior Fossa Mutism on Quality of Life
An observational study of Posterior Fossa Mutism, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Posterior Fossa Mutism
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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. We will identify a group of patients who developed PFM as well as a group of appropriately matched controls with regard to age, sex and treatment protocol who did not develop PFM.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
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.
- Conditions
- Posterior Fossa Mutism
- Keywords
- Mutism
- Medical subject headings
- Mutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Posterior Fossa Mutism | Patients with Posterior Fossa Mutism | |
| Non Posterior Fossa Mutism | Patients that did not develop Mutism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Measured: Thirty minutes, no follow-up.
Secondary outcomes (1)
quality of life in terms of anger, anxiety, depression, fatigue, social functioning, pain and stigma
Measured: 30 minutes, no follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startJul 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Posterior Fossa MutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048176
- Sponsor's protocol ID
- 2011-14721
- Status last verified
- Jul 2017
- First submitted
- 27 Jan 2014
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21061011Kupeli S, Yalcin B, Bilginer B, Akalan N, Haksal P, Buyukpamukcu 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.
PubMed 21157890Palmer 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.
PubMed 20713408Szathmari A, Thiesse P, Galand-desme S, Mottolese C, Bret P, Jouanneau E, Guyotat J, Lion-Francois 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.
PubMed 20981689Wells 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.
PubMed 18924161Ozgur BM, Berberian J, Aryan HE, Meltzer HS, Levy ML. The pathophysiologic mechanism of cerebellar mutism. Surg Neurol. 2006 Jul;66(1):18-25. doi: 10.1016/j.surneu.2005.12.003.
PubMed 16793430Robertson 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. doi: 10.3171/ped.2006.105.6.444.
PubMed 17184075
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Impact of Posterior Fossa Mutism on Quality of Life
- ClinicalTrials.gov ID
- NCT02048176
- Acronym / sponsor ID
- 2011-14721
- Conditions
- Posterior Fossa Mutism
- Keywords
- Mutism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior Fossa Mutism | – | –Patients with Posterior Fossa Mutism |
| Non Posterior Fossa Mutism | – | –Patients that did not develop Mutism |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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. We will identify a group of patients who developed PFM as well as a group of appropriately matched controls with regard to age, sex and treatment protocol who did not develop PFM.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Life
Time frame: Thirty minutes, no follow-up.
1 secondary outcome
quality of life in terms of anger, anxiety, depression, fatigue, social functioning, pain and stigma
Time frame: 30 minutes, no follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Background: PubMed 21061011Gudrunardottir 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.
- Background: PubMed 21157890Kupeli S, Yalcin B, Bilginer B, Akalan N, Haksal P, Buyukpamukcu 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.
- Background: PubMed 20713408Palmer 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.
- Background: PubMed 20981689Szathmari A, Thiesse P, Galand-desme S, Mottolese C, Bret P, Jouanneau E, Guyotat J, Lion-Francois 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.
- Background: PubMed 18924161Wells 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.
- Background: PubMed 16793430Ozgur BM, Berberian J, Aryan HE, Meltzer HS, Levy ML. The pathophysiologic mechanism of cerebellar mutism. Surg Neurol. 2006 Jul;66(1):18-25. doi: 10.1016/j.surneu.2005.12.003.
- Background: PubMed 17184075Robertson 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. doi: 10.3171/ped.2006.105.6.444.
- Individual participant dataSharing planned: Undecided
Related trials for Posterior Fossa Mutism
RecruitingObservational study
Cerebellar Mutism Syndrome Study
Infratentorial Neoplasms, Mutism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Fossa Mutism, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: Thirty minutes, no follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02048176, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.