Clinical trial · Observational
Measuring and Mapping Cognitive Decline After Brain Radiosurgery
Measuring and Mapping Cognitive Decline After Brain Radiosurgery: a Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background Stereotactic Radiosurgery (SRS) is a localised radiotherapy treatment for patients with brain metastases or other benign tumours in the brain, like meningiomas. The Investigators do not currently know if, or how much, SRS affects brain function. Patients with brain tumours do not get tested routinely for their brain function. Understanding short- and long-term side-effects is important for SRS. Brain metastases patients have short life expectancies (6-months to 1-year). However, meningioma patients can live 10 years or more. SRS is used to treat both. The Montreal Cognitive Assessment will be used to test the participants' brain function. Quality-of-life questionnaires QLQ-C30 and BN20 will also be used to assess the participants' physical and mental wellbeing . These are specific for patients with brain cancer. Why is it important This study aims to identify areas in the brain that relate to changes in brain function after SRS. These areas can then have the radiation dose reduced to them in future patients, hoping to minimise side-effects. Research Question Which regions of the brain contribute to a decline in brain function following SRS. Study Design This is a single centre observational study with prospective and retrospective collection of data. This study will look at two groups of patients: Group1: Patients will complete the MoCA and two quality-of-life questionnaires before the treatment and every 3 months for a year. Group2: Patients will complete the MoCA and two quality-of-life questionnaires once. The investigators will use these tests, MRI scans and the SRS treatment plan to identify areas of the brain that are responsible for any problems with the participants' brain function. The participants for Group 1 will be recruited from the SRS Clinics, at City Campus, Nottingham University Hospitals NHS Trust. The participants for Group 2 will be identified through the Mosaiq Oncology Information System. This pilot study is funded by the Midlands Mental Health and Neurosciences Network.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
| Cognitive Decline | — | UNRESOLVED | — |
| Meningiomas | Meningioma | ALIAS | 0.90 |
| Quality of Life | — | UNRESOLVED | — |
| SRS | — | UNRESOLVED | — |
| Stereotactic Radiosurgery | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neurocognitive testing | Behavioral | — | UNRESOLVED |
| Quality of Life questionnaire | Behavioral | — | UNRESOLVED |
| Stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Prospective
- description
- Patients with brain metastases and meningiomas that are eligible for SRS treatment will be included in the prospective arm of the trial. The patients will have neurocognitive testing in the form of the Montreal Cognitive Assessment (MoCA) and will answer two Quality of Life questionnaires (QLQs) by EORTC QLQ-C30 and BN20). The baseline visit will happen before they start their SRS treatment. The patients will be seen an additional 4 times, at 3, 6, 9 and 12 months after radiotherapy treatment. During each visit they will complete the MoCA and the QLQs. During the first follow up appointment they will also be asked to think back to before they had the treatment and answer the QLQs based on that.
- interventionNames
- Behavioral: Neurocognitive testing
- Behavioral: Quality of Life questionnaire
- Radiation: Stereotactic radiosurgery
- label
- Retrospective
- description
- Patients with meningiomas that have received SRS treatment more than a year ago will be included in the retrospective arm of the trial. The patients will have neurocognitive testing in the form of the Montreal Cognitive Assessment (MoCA) and will answer two Quality of Life questionnaires (QLQs) by EORTC QLQ-C30 and BN20) once. They will also be asked to think back to before they had the treatment and answer the QLQs based on that.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria Prospective Cohort Patients will be eligible for inclusion only if ALL of the following criteria apply: * Age: above 18 years, no upper limit * Diagnosis of brain metastases or meningioma, where the treatment is going to be stereotactic radiosurgery * Karnofsky Performance Status (KPS) ≥70 * Established diagnosis of cancer with absent or controllable primary disease * Tumour volume of less than 20cc * Life expectancy of more than 6 months * Able to give informed consent Exclusion criteria Prospective Cohort * Previous RT to the brain, including SRS * Previous surgery to the brain * Not willing or not able to give informed consent Inclusion criteria Retrospective Cohort Patients will be eligible for inclusion only if ALL of the following criteria apply: * Age: above 18 years, no upper limit * Diagnosis of meningioma * Previous SRS treatment at least 1 year prior to inclusion in the study * Most recent MRI scan (within 1 year) shows stable appearances * Able to give informed consent Exclusion criteria Retrospective Cohort * Previous RT to the brain, excluding SRS * Previous surgery to the brain * Not willing or not able to give informed consent
References
Publications (22)
- BACKGROUNDLamba N, Muskens IS, DiRisio AC, Meijer L, Briceno V, Edrees H, Aslam B, Minhas S, Verhoeff JJC, Kleynen CE, Smith TR, Mekary RA, Broekman ML. Stereotactic radiosurgery versus whole-brain radiotherapy after intracranial metastasis resection: a systematic review and meta-analysis. Radiat Oncol. 2017 Jun 24;12(1):106. doi: 10.1186/s13014-017-0840-x. PMID 28646895
- BACKGROUNDLippitz B, Lindquist C, Paddick I, Peterson D, O'Neill K, Beaney R. Stereotactic radiosurgery in the treatment of brain metastases: the current evidence. Cancer Treat Rev. 2014 Feb;40(1):48-59. doi: 10.1016/j.ctrv.2013.05.002. Epub 2013 Jun 27. PMID 23810288
- BACKGROUNDBates E, Wilson SM, Saygin AP, Dick F, Sereno MI, Knight RT, Dronkers NF. Voxel-based lesion-symptom mapping. Nat Neurosci. 2003 May;6(5):448-50. doi: 10.1038/nn1050. No abstract available. PMID 12704393
- BACKGROUNDGlascher J, Tranel D, Paul LK, Rudrauf D, Rorden C, Hornaday A, Grabowski T, Damasio H, Adolphs R. Lesion mapping of cognitive abilities linked to intelligence. Neuron. 2009 Mar 12;61(5):681-91. doi: 10.1016/j.neuron.2009.01.026. PMID 19285465
- BACKGROUNDGeva S, Baron JC, Jones PS, Price CJ, Warburton EA. A comparison of VLSM and VBM in a cohort of patients with post-stroke aphasia. Neuroimage Clin. 2012 Aug 30;1(1):37-47. doi: 10.1016/j.nicl.2012.08.003. eCollection 2012. PMID 24179735
- BACKGROUNDTaphoorn MJ, Claassens L, Aaronson NK, Coens C, Mauer M, Osoba D, Stupp R, Mirimanoff RO, van den Bent MJ, Bottomley A; EORTC Quality of Life Group, and Brain Cancer, NCIC and Radiotherapy Groups. An international validation study of the EORTC brain cancer module (EORTC QLQ-BN20) for assessing health-related quality of life and symptoms in brain cancer patients. Eur J Cancer. 2010 Apr;46(6):1033-40. doi: 10.1016/j.ejca.2010.01.012. Epub 2010 Feb 22. PMID 20181476
- Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.