Clinical trial NCT04501731: Controlling Coordination After Childhood Cerebellar Cancer, a Pilot Study
Official title: Controlling Coordination After Childhood Cerebellar Cancer - Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Cancer
Keywords: Motor recovery
Transcranial Magnetic Stimulation
Magnetic Resonance Imaging
Paediatric
Cerebellum
Posterior Fossa Tumour
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Nottingham University Hospital NHS Trust
name: Nottingham Hospitals Charity
First posted: 2020-08-06
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 4 participants with history of PFT (no history of seizure, no current cancer treatment) 6 healthy controls (no history of brain injury)

Brief summary: Posterior fossa tumours (PFT) account for 2/3 of childhood brain cancers. They can be highly malignant requiring combined chemotherapy and radiotherapy post-surgery for a \>50% chance of cure. PFT frequently involve the cerebellum which is responsible for coordinating movement, balance, emotional control, and links closely to control of affect and executive function. PFT survivors show highly variable profiles for cognitive and sensorimotor functioning which are influenced strongly by the severity of the pre-diagnostic or post-surgical brain injury

State-of-the-art magnetic resonance imaging (MRI) scans can allow to measure a variety of different biological processes in the brain, and the investigators believe that some of these MRI measures (called MRI biomarkers) have the potential to improve our ability to understand and monitor consequences of the ablative brain surgery and complex mechanisms of motor skills recovery. Biomarkers are very important for the development of intervention because 1) they help understand the recuperation process and 2) they allow to effectively assess whether or not a treatment or intervention works.

Transcranial magnetic stimulation (TMS) is a powerful non-invasive neuro-modulatory intervention that has the potential to evaluate the integrity of the nervous tracts from the brain to the hand. It is a procedure that applies magnetic pulses on the surface of the scalp to reach underlying brain tissue. TMS has built a reputable status among neuro-rehabilitative research, and there is currently a major effort to translate the positive research findings into clinically useful therapeutic strategies.

This study is therefore an important first step towards understanding how potential MRI biomarkers and responses to TMS relate to motor symptoms in PFT young survivors. Once completed, this study will allow the investigators to select the most promising MRI biomarkers and TMS protocols to take forward into future treatment trials. The investigators aim to stimulate the recovery of coordination skills, help the development of targeted therapies, and consequently improve long-term quality of life in children and young people with history of brain tumour.

The proposed research intends to prove the feasibility of such brain stimulation and imaging and collect some preliminary measures


Eligibility criteria: Inclusion Criteria:

* Able to undergo MRI scan without sedation or general anaesthetic
* Able to give informed consent.

Exclusion Criteria:

* History of seizure
* Current cancer or post surgery treatment
* Contraindication to TMS or MRI
* Pregnancy

Primary outcomes:
measure: 5C-pilot Satisfaction Questionnaire
timeFrame: 6 months
measure: Completion rate of the sessions of TMS, MRI and motor tasks
timeFrame: 6 months
Secondary outcomes:
measure: Anatomical MRI metrics (PFT vs control)
timeFrame: 1 year
measure: fMRI metrics (PFT vs control)
timeFrame: 1 year
measure: Diffusion MRI metrics (PFT vs control)
timeFrame: 1 year
measure: Single-pulse TMS metrics (PFT vs control)
timeFrame: 1 year
measure: Single-pulse TMS metrics (PFT vs control)
timeFrame: 1 year
measure: Single-pulse TMS metrics (PFT vs control)
timeFrame: 1 year
measure: Single-pulse TMS metrics (PFT vs control)
timeFrame: 1 year
measure: Dual-pulse TMS metrics (PFT vs control)
timeFrame: 1 year
measure: Dual-pulse TMS metrics (PFT vs control)
timeFrame: 1 year
measure: Motor performance (PFT vs control) - Reaching and grasping task
timeFrame: 1 year
measure: Motor performance (PFT vs control) - Grooved pegboard
timeFrame: 1 year
measure: Motor performance (PFT vs control) - Grip force
timeFrame: 1 year
measure: Quality of life of PFT survivors: FACT-Peds-Br Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
Study officials:
References: