Controlling Coordination After Childhood Cerebellar Cancer, a Pilot Study
- Conditions
- Brain Cancer
- Interventions
- Other: Transcranial Magnetic Stimulation (TMS)Other: Magnetic Resonance Imaging (MRI)Other: Motor assessmentOther: Questionnaires
- Registration Number
- NCT04501731
- Lead Sponsor
- University of Nottingham
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- Able to undergo MRI scan without sedation or general anaesthetic
- Able to give informed consent.
- History of seizure
- Current cancer or post surgery treatment
- Contraindication to TMS or MRI
- Pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Young PFT survivors Transcranial Magnetic Stimulation (TMS) - Age-matching controls Motor assessment - Age-matching controls Magnetic Resonance Imaging (MRI) - Young PFT survivors Magnetic Resonance Imaging (MRI) - Young PFT survivors Questionnaires - Young PFT survivors Motor assessment - Age-matching controls Transcranial Magnetic Stimulation (TMS) -
- Primary Outcome Measures
Name Time Method Completion rate of the sessions of TMS, MRI and motor tasks 6 months Measure of quality of MRI images (participants motion) - Feasibility will be confirmed if 50% or more of these participants complete the TMS session
5C-pilot Satisfaction Questionnaire 6 months Participants rating their experience of MRI, TMS and motor assessment
- Secondary Outcome Measures
Name Time Method Motor performance (PFT vs control) - Grooved pegboard 1 year Score
Anatomical MRI metrics (PFT vs control) 1 year Cerebellar volumetry and cerebellar parcellation - after surgery (mm3)
Diffusion MRI metrics (PFT vs control) 1 year Anatomical connectivity within sensorimotor network (tractography)
Single-pulse TMS metrics (PFT vs control) 1 year Short-afferent inhibition
Dual-pulse TMS metrics (PFT vs control) 1 year cerebellar-motor inhibition
fMRI metrics (PFT vs control) 1 year Functional connectivity within sensorimotor network (activation map)
Quality of life of PFT survivors: FACT-Peds-Br Questionnaire 6 months FACT-Peds-Br Pediatric Questionnaire - For patients with Brain cancer
Motor performance (PFT vs control) - Grip force 1 year Maximum force (N)
Motor performance (PFT vs control) - Reaching and grasping task 1 year Kinematic parameters of movement
Trial Locations
- Locations (1)
Queen's Medical Centre
🇬🇧Nottingham, United Kingdom