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Controlling Coordination After Childhood Cerebellar Cancer, a Pilot Study

Controlling Coordination After Childhood Cerebellar Cancer - Pilot Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04501731
Acronym
5C-pilot
Enrollment
10
Registered
2020-08-06
Start date
2022-04-28
Completion date
2022-12-31
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Cancer

Keywords

Motor recovery, Transcranial Magnetic Stimulation, Magnetic Resonance Imaging, Paediatric, Cerebellum, Posterior Fossa Tumour

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

Interventions

OTHERTranscranial Magnetic Stimulation (TMS)

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.

OTHERMagnetic Resonance Imaging (MRI)

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.

OTHERQuestionnaires

Feasibility, tolerability of such intervention as well as quality of life of PFT survivors will be assessed thanks to questionnaires.

Sponsors

Nottingham University Hospital NHS Trust
CollaboratorUNKNOWN
Nottingham Hospitals Charity
CollaboratorUNKNOWN
University of Nottingham
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
16 Years to 22 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
5C-pilot Satisfaction Questionnaire6 monthsParticipants rating their experience of MRI, TMS and motor assessment
Completion rate of the sessions of TMS, MRI and motor tasks6 monthsMeasure of quality of MRI images (participants motion) - Feasibility will be confirmed if 50% or more of these participants complete the TMS session

Secondary

MeasureTime frameDescription
Diffusion MRI metrics (PFT vs control)1 yearAnatomical connectivity within sensorimotor network (tractography)
Single-pulse TMS metrics (PFT vs control)1 yearResting motor threshold (Stimulus intensity expressed as a percentage of maximal stimulator output)
Dual-pulse TMS metrics (PFT vs control)1 yearIntracortical & long-latency inhibition and facilitation
Anatomical MRI metrics (PFT vs control)1 yearCerebellar volumetry and cerebellar parcellation - after surgery (mm3)
Motor performance (PFT vs control) - Grooved pegboard1 yearScore
Motor performance (PFT vs control) - Grip force1 yearMaximum force (N)
Quality of life of PFT survivors: FACT-Peds-Br Questionnaire6 monthsFACT-Peds-Br Pediatric Questionnaire - For patients with Brain cancer
Motor performance (PFT vs control) - Reaching and grasping task1 yearKinematic parameters of movement
fMRI metrics (PFT vs control)1 yearFunctional connectivity within sensorimotor network (activation map)

Countries

United Kingdom

Contacts

Primary ContactCaroline Blanchard
caroline.blanchard@nottingham.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026