Controlling Coordination After Childhood Cerebellar Cancer, a Pilot Study
NCT ID: NCT04501731
Last Updated: 2022-05-25
Study Results
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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UNKNOWN
10 participants
OBSERVATIONAL
2022-04-28
2022-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Young PFT survivors
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.
Magnetic Resonance Imaging (MRI)
With the MRI scan we will gather information about the brain structure and function. This will last around 30 minutes.
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.
Questionnaires
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)
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)
With the MRI scan we will gather information about the brain structure and function. This will last around 30 minutes.
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.
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.
Magnetic Resonance Imaging (MRI)
With the MRI scan we will gather information about the brain structure and function. This will last around 30 minutes.
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.
Questionnaires
Feasibility, tolerability of such intervention as well as quality of life of PFT survivors will be assessed thanks to questionnaires.
Eligibility Criteria
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Inclusion Criteria
* Able to give informed consent.
Exclusion Criteria
* Current cancer or post surgery treatment
* Contraindication to TMS or MRI
* Pregnancy
16 Years
22 Years
ALL
Yes
Sponsors
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Nottingham University Hospital NHS Trust
UNKNOWN
Nottingham Hospitals Charity
UNKNOWN
University of Nottingham
OTHER
Responsible Party
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Locations
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Queen's Medical Centre
Nottingham, , United Kingdom
Countries
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Central Contacts
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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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