Brain Cancer5C-pilotNCT04501731
Controlling Coordination After Childhood Cerebellar Cancer, a Pilot Study
An observational study of Brain Cancer, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Cancer
- What is being tested?
- Transcranial Magnetic Stimulation (TMS), Magnetic Resonance Imaging (MRI) and Motor assessment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Apr 2022to 31 Dec 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 4 participants with history of PFT (no history of seizure, no current cancer treatment) 6 healthy controls (no history of brain injury)
Who may be able to join
- Able to undergo MRI scan without sedation or general anaesthetic
- Able to give informed consent.
Who cannot join
- History of seizure
- Current cancer or post surgery treatment
- Contraindication to TMS or MRI
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Caroline Blanchard contact
United Kingdom1 site, 1 recruiting
- Recruiting
Queen's Medical Centre
Nottingham
Madhumati Dandapani
About this study
Official title: Controlling Coordination After Childhood Cerebellar Cancer - Pilot Study
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.
Read more
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
- Conditions
- Brain Cancer
- Being tested
- Transcranial Magnetic Stimulation (TMS), Magnetic Resonance Imaging (MRI), Motor assessment, Questionnaires
- Keywords
- Motor recovery, Transcranial Magnetic Stimulation, Magnetic Resonance Imaging, Paediatric, Cerebellum, Posterior Fossa Tumour
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)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)Other
With the MRI scan we will gather information about the brain structure and function. This will last around 30 minutes.
Motor assessmentOther
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.
QuestionnairesOther
Feasibility, tolerability of such intervention as well as quality of life of PFT survivors will be assessed thanks to questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Young PFT survivors | Not described Receives: Other: Transcranial Magnetic Stimulation (TMS); Other: Magnetic Resonance Imaging (MRI); Other: Motor assessment; Other: Questionnaires | |
| Age-matching controls | Not described Receives: Other: Transcranial Magnetic Stimulation (TMS); Other: Magnetic Resonance Imaging (MRI); Other: Motor assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
5C-pilot Satisfaction Questionnaire
Participants rating their experience of MRI, TMS and motor assessment
Measured: 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
Measured: 6 months
Secondary outcomes (13)
Anatomical MRI metrics (PFT vs control)
Cerebellar volumetry and cerebellar parcellation - after surgery (mm3)
Measured: 1 year
fMRI metrics (PFT vs control)
Functional connectivity within sensorimotor network (activation map)
Measured: 1 year
Diffusion MRI metrics (PFT vs control)
Anatomical connectivity within sensorimotor network (tractography)
Measured: 1 year
Single-pulse TMS metrics (PFT vs control)
Resting motor threshold (Stimulus intensity expressed as a percentage of maximal stimulator output)
Measured: 1 year
Single-pulse TMS metrics (PFT vs control)
input-output curve
Measured: 1 year
Single-pulse TMS metrics (PFT vs control)
Silent period (ms)
Measured: 1 year
Single-pulse TMS metrics (PFT vs control)
Short-afferent inhibition
Measured: 1 year
Dual-pulse TMS metrics (PFT vs control)
Intracortical \& long-latency inhibition and facilitation
Measured: 1 year
Dual-pulse TMS metrics (PFT vs control)
cerebellar-motor inhibition
Measured: 1 year
Motor performance (PFT vs control) - Reaching and grasping task
Kinematic parameters of movement
Measured: 1 year
Motor performance (PFT vs control) - Grooved pegboard
Score
Measured: 1 year
Motor performance (PFT vs control) - Grip force
Maximum force (N)
Measured: 1 year
Quality of life of PFT survivors: FACT-Peds-Br Questionnaire
FACT-Peds-Br Pediatric Questionnaire - For patients with Brain cancer
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start28 Apr 2022
- Primary completion30 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, Nottingham Hospitals Charity
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501731
- Sponsor's protocol ID
- 20047
- Acronym
- 5C-pilot
- Status last verified
- Sep 2021
- First submitted
- 23 Jul 2020
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlling Coordination After Childhood Cerebellar Cancer - Pilot Study
- ClinicalTrials.gov ID
- NCT04501731
- Acronym / sponsor ID
- 5C-pilot / 20047
- Conditions
- Brain Cancer
- Keywords
- Motor recovery, Transcranial Magnetic Stimulation, Magnetic Resonance Imaging, Paediatric, Cerebellum, Posterior Fossa Tumour
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, Nottingham Hospitals Charity
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young PFT survivors | – | Other: Transcranial Magnetic Stimulation (TMS), Other: Magnetic Resonance Imaging (MRI), Other: Motor assessment, Other: Questionnaires |
| Age-matching controls | – | Other: Transcranial Magnetic Stimulation (TMS), Other: Magnetic Resonance Imaging (MRI), Other: Motor assessment |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 4 participants with history of PFT (no history of seizure, no current cancer treatment) 6 healthy controls (no history of brain injury)
Key inclusion criteria (2 listed)
- Able to undergo MRI scan without sedation or general anaesthetic
- Able to give informed consent.
Key exclusion criteria (4 listed)
- History of seizure
- Current cancer or post surgery treatment
- Contraindication to TMS or MRI
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Age-matching controls, Young PFT survivors |
| Magnetic Resonance Imaging (MRI)With the MRI scan we will gather information about the brain structure and function. This will last around 30 minutes. | Other | Age-matching controls, Young PFT survivors |
| Motor assessmentThe 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. | Other | Age-matching controls, Young PFT survivors |
| QuestionnairesFeasibility, tolerability of such intervention as well as quality of life of PFT survivors will be assessed thanks to questionnaires. | Other | Young PFT survivors |
Primary outcome
5C-pilot Satisfaction Questionnaire
Time frame: 6 months
Participants rating their experience of MRI, TMS and motor assessment
Completion rate of the sessions of TMS, MRI and motor tasks
Time frame: 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
13 secondary outcomes
Anatomical MRI metrics (PFT vs control)
Time frame: 1 year
fMRI metrics (PFT vs control)
Time frame: 1 year
Diffusion MRI metrics (PFT vs control)
Time frame: 1 year
Single-pulse TMS metrics (PFT vs control)
Time frame: 1 year
Single-pulse TMS metrics (PFT vs control)
Time frame: 1 year
Single-pulse TMS metrics (PFT vs control)
Time frame: 1 year
Single-pulse TMS metrics (PFT vs control)
Time frame: 1 year
Dual-pulse TMS metrics (PFT vs control)
Time frame: 1 year
Dual-pulse TMS metrics (PFT vs control)
Time frame: 1 year
Motor performance (PFT vs control) - Reaching and grasping task
Time frame: 1 year
Motor performance (PFT vs control) - Grooved pegboard
Time frame: 1 year
Motor performance (PFT vs control) - Grip force
Time frame: 1 year
Quality of life of PFT survivors: FACT-Peds-Br Questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Blanchard contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Cancer, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Blanchard (caroline.blanchard@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5C-pilot Satisfaction Questionnaire (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.