Controlling Coordination After Childhood Cerebellar Cancer, a Pilot Study
5C-pilot
1 other identifier
observational
10
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2020
CompletedFirst Posted
Study publicly available on registry
August 6, 2020
CompletedStudy Start
First participant enrolled
April 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMay 25, 2022
September 1, 2021
3 months
July 23, 2020
May 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
5C-pilot Satisfaction Questionnaire
Participants rating their experience of MRI, TMS and motor assessment
6 months
Completion rate of the sessions of TMS, MRI and motor tasks
Measure of quality of MRI images (participants motion) - Feasibility will be confirmed if 50% or more of these participants complete the TMS session
6 months
Secondary Outcomes (13)
Anatomical MRI metrics (PFT vs control)
1 year
fMRI metrics (PFT vs control)
1 year
Diffusion MRI metrics (PFT vs control)
1 year
Single-pulse TMS metrics (PFT vs control)
1 year
Single-pulse TMS metrics (PFT vs control)
1 year
- +8 more secondary outcomes
Study Arms (2)
Young PFT survivors
Age-matching controls
Interventions
With the TMS session we gather information about nerve fibres from the brain to the hand. It will last around 2 hours and 30 minutes.
With the MRI scan we will gather information about the brain structure and function. This will last around 30 minutes.
The motor assessment includes a pegboard game, a "grab the alien nose" game and measure of your maximum grip force. In total it will last around 30 minutes.
Feasibility, tolerability of such intervention as well as quality of life of PFT survivors will be assessed thanks to questionnaires.
Eligibility Criteria
4 participants with history of PFT (no history of seizure, no current cancer treatment) 6 healthy controls (no history of brain injury)
You may qualify if:
- Able to undergo MRI scan without sedation or general anaesthetic
- Able to give informed consent.
You may not qualify if:
- History of seizure
- Current cancer or post surgery treatment
- Contraindication to TMS or MRI
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nottinghamlead
- Nottingham University Hospital NHS Trustcollaborator
- Nottingham Hospitals Charitycollaborator
Study Sites (1)
Queen's Medical Centre
Nottingham, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2020
First Posted
August 6, 2020
Study Start
April 28, 2022
Primary Completion
July 30, 2022
Study Completion
December 31, 2022
Last Updated
May 25, 2022
Record last verified: 2021-09