Controlling Coordination After Childhood Cerebellar Cancer, a Pilot Study

NCT ID: NCT04501731

Last Updated: 2022-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-28

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Brain Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Young PFT survivors

Transcranial Magnetic Stimulation (TMS)

Intervention Type OTHER

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.

Magnetic Resonance Imaging (MRI)

Intervention Type OTHER

With the MRI scan we will gather information about the brain structure and function. This will last around 30 minutes.

Motor assessment

Intervention Type OTHER

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.

Questionnaires

Intervention Type OTHER

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

Age-matching controls

Transcranial Magnetic Stimulation (TMS)

Intervention Type OTHER

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.

Magnetic Resonance Imaging (MRI)

Intervention Type OTHER

With the MRI scan we will gather information about the brain structure and function. This will last around 30 minutes.

Motor assessment

Intervention Type OTHER

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.

Interventions

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Transcranial 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.

Intervention Type OTHER

Magnetic Resonance Imaging (MRI)

With the MRI scan we will gather information about the brain structure and function. This will last around 30 minutes.

Intervention Type OTHER

Motor assessment

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.

Intervention Type OTHER

Questionnaires

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nottingham University Hospital NHS Trust

UNKNOWN

Sponsor Role collaborator

Nottingham Hospitals Charity

UNKNOWN

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Queen's Medical Centre

Nottingham, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Caroline Blanchard

Role: CONTACT

Facility Contacts

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Madhumati Dandapani

Role: primary

Other Identifiers

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20047

Identifier Type: -

Identifier Source: org_study_id

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