Controlling Coordination After Childhood Cerebellar Cancer, a Pilot Study

Brain Cancer Clinical Trial

— 5C-pilot  

Official title:

Controlling Coordination After Childhood Cerebellar Cancer - Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04501731
• Other study ID #: 20047
• Status: Recruiting
• Start date: April 28, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: University of Nottingham
• Contact: Caroline Blanchard
• Email: caroline.blanchard[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms
• Cerebellar Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	Queen's Medical Centre	Nottingham

Sponsors (3)

Lead Sponsor	Collaborator
University of Nottingham	Nottingham Hospitals Charity, Nottingham University Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5C-pilot Satisfaction Questionnaire	Participants rating their experience of MRI, TMS and motor assessment	6 months
Primary	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	Anatomical MRI metrics (PFT vs control)	Cerebellar volumetry and cerebellar parcellation - after surgery (mm3)	1 year
Secondary	fMRI metrics (PFT vs control)	Functional connectivity within sensorimotor network (activation map)	1 year
Secondary	Diffusion MRI metrics (PFT vs control)	Anatomical connectivity within sensorimotor network (tractography)	1 year
Secondary	Single-pulse TMS metrics (PFT vs control)	Resting motor threshold (Stimulus intensity expressed as a percentage of maximal stimulator output)	1 year
Secondary	Single-pulse TMS metrics (PFT vs control)	input-output curve	1 year
Secondary	Single-pulse TMS metrics (PFT vs control)	Silent period (ms)	1 year
Secondary	Single-pulse TMS metrics (PFT vs control)	Short-afferent inhibition	1 year
Secondary	Dual-pulse TMS metrics (PFT vs control)	Intracortical & long-latency inhibition and facilitation	1 year
Secondary	Dual-pulse TMS metrics (PFT vs control)	cerebellar-motor inhibition	1 year
Secondary	Motor performance (PFT vs control) - Reaching and grasping task	Kinematic parameters of movement	1 year
Secondary	Motor performance (PFT vs control) - Grooved pegboard	Score	1 year
Secondary	Motor performance (PFT vs control) - Grip force	Maximum force (N)	1 year
Secondary	Quality of life of PFT survivors: FACT-Peds-Br Questionnaire	FACT-Peds-Br Pediatric Questionnaire - For patients with Brain cancer	6 months