DystoniaNCT05612464
Enhancing Sensorimotor Processing in Children With Dystonia
An observational study of Dystonia and Dystonic Cerebral Palsy, run by King's College London.
Trial summary
Dystonia is a severely disabling movement disorder with no cure, in which people suffer painful muscle spasms causing twisting movements and abnormal postures. There are many causes, including genetic conditions and brain injury. Read more about this study
- Who is it for?
- Ages 5 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dystonia, Dystonic Cerebral Palsy, Dystonia, Secondary
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 5 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Population to be researched is children/young people with dystonia / dystonic cerebral palsy. Age range 5-25 years
Who may be able to join
- Control Group:
- Age 5 -25 years
- No known disorder of movement
- Able to understand and participate in study.
- Primary dystonia group (isolated genetic or idiopathic):
- Age 5-25 years
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- Clinical dystonia - as confirmed on clinical assessment by consultant paediatric neurologist.
- Genetic or idiopathic aetiology.
- No other neurological abnormality.
- Normal cranial magnetic resonance imaging (MRI).
- Able to understand and participate in study.
- Dystonic Cerebral Palsy Group:
- Age 5-25 years
- Clinical dystonia/dyskinesia - as confirmed on clinical assessment by consultant paediatric neurologist.
- Documented history of perinatal hypoxic-ischaemic encephalopathy (HIE), prematurity <35 weeks or kernicterus.
- Predominant dystonia/dyskinesia / Minimal spasticity
- MRI findings in keeping with acute perinatal HIE, prematurity or kernicterus (including classical pattern of damage to thalami, basal ganglia and peri-rolandic cortex, periventricular leukomalacia or ischaemic parenchymal injury).
- Able to understand and participate in study.
Who cannot join
- Control Group:
- Age <5 or >25 years
- Any known disorder of movement.
- Primary dystonia group (isolated genetic or idiopathic):
- Age < 5 or >25 years
- Presence of other neurological abnormality in addition to dystonia.
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- Abnormal cranial MRI.
- Dystonic Cerebral Palsy Group:
- Age < 5 or >25 years
- No clear history of perinatal HIE, prematurity or kernicterus.
- Predominant spasticity.
- MRI scan not compatible with perinatal HIE, prematurity or kernicterus
About this study
Official title: Enhancing Cortical Sensorimotor Processing in Children/Young People With Dystonia and Dystonic Cerebral Palsy - An Observational Study to Evaluate Whether Neurofeedback Can Enhance Modulation of the mu Brain Rhythm in Children and Young People With Dystonia/Dystonic Cerebral Palsy
Dystonia is a severely disabling movement disorder with no cure, in which people suffer painful muscle spasms causing twisting movements and abnormal postures. There are many causes, including genetic conditions and brain injury. The most common cause in childhood is dystonic cerebral palsy (CP) which often affects the whole body.
The underlying mechanisms are unknown, but there is growing evidence to implicate abnormal brain processing by the brain of incoming "sensory" information (e.g., signals to the brain from our senses of touch and body position): the distorted perception of these signals disrupts the way the brain produces instructions for planning and performing movements.
Read more
The investigator's previous studies have shown that the way the brain processes sensory information related to movement is abnormal in children with dystonia and dystonic CP, by using methods that record the EEG (electroencephalogram - brain wave signals) and/or EMG (electromyogram - electrical signal from muscles). A specific brain rhythm (called mu) typically shows well-defined changes in response to movement, and reflects processing of sensory information. The investigator's work shows these rhythm changes are abnormal in children with dystonia/dystonic CP.
This study will explore if these findings can improve treatment. In particular the study team will investigate whether children and young people with dystonia/dystonic CP can enhance these mu rhythm responses during a movement task by using feedback of their brain rhythms displayed as a cartoon/game on a computer. The investigators will also assess whether enhanced mu activity is associated with improved movement control. This would open future possibilities to use such devices for therapy/rehabilitation.
Children and young people with dystonia/dystonic CP aged 5-25 years will be recruited, along with age-matched controls. Studies will last 2-3 hours with time for breaks and will be conducted at Evelina London Children's Hospital and Barts Health Trust, with the option for home visits if preferable for families.
- Conditions
- Dystonia, Dystonic Cerebral Palsy, Dystonia, Secondary, Dystonia, Primary, Dystonia; Idiopathic
- Being tested
- No intervention
- Medical subject headings
- Dystonia, Dystonic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Primary dystonia group (genetic or idiopathic) | Not described Receives: Other: No intervention | |
| Dystonic cerebral palsy group | Not described Receives: Other: No intervention | |
| Control group | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mu modulation between trials with and without biofeedback
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Feb 2023 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Barts & The London NHS Trust, Imperial College London, University of Bristol, University of Calgary
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612464
- Sponsor's protocol ID
- 317454
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will have exclusive use of the data for the project duration and five years afterwards to allow for publications to be achieved. After this period, the majority of data would be made available for data sharing via the King's College London data repository. Only non-identifiable data will be available.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cortical Sensorimotor Processing in Children/Young People With Dystonia and Dystonic Cerebral Palsy - An Observational Study to Evaluate Whether Neurofeedback Can Enhance Modulation of the mu Brain Rhythm in Children and Young People With Dystonia/Dystonic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05612464
- Acronym / sponsor ID
- 317454
- Conditions
- Dystonia, Dystonic Cerebral Palsy, Dystonia, Secondary, Dystonia, Primary, Dystonia; Idiopathic
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Barts & The London NHS Trust, Imperial College London, University of Bristol, University of Calgary
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 10 Nov 2022 (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.
Dystonia is a severely disabling movement disorder with no cure, in which people suffer painful muscle spasms causing twisting movements and abnormal postures. There are many causes, including genetic conditions and brain injury. The most common cause in childhood is dystonic cerebral palsy (CP) which often affects the whole body.
The underlying mechanisms are unknown, but there is growing evidence to implicate abnormal brain processing by the brain of incoming "sensory" information (e.g., signals to the brain from our senses of touch and body position): the distorted perception of these signals disrupts the way the brain produces instructions for planning and performing movements.
The investigator's previous studies have shown that the way the brain processes sensory information related to movement is abnormal in children with dystonia and dystonic CP, by using methods that record the EEG (electroencephalogram - brain wave signals) and/or EMG (electromyogram - electrical signal from muscles). A specific brain rhythm (called mu) typically shows well-defined changes in response to movement, and reflects processing of sensory information. The investigator's work shows these rhythm changes are abnormal in children with dystonia/dystonic CP.
This study will explore if these findings can improve treatment. In particular the study team will investigate whether children and young people with dystonia/dystonic CP can enhance these mu rhythm responses during a movement task by using feedback of their brain rhythms displayed as a cartoon/game on a computer. The investigators will also assess whether enhanced mu activity is associated with improved movement control. This would open future possibilities to use such devices for therapy/rehabilitation.
Children and young people with dystonia/dystonic CP aged 5-25 years will be recruited, along with age-matched controls. Studies will last 2-3 hours with time for breaks and will be conducted at Evelina London Children's Hospital and Barts Health Trust, with the option for home visits if preferable for families.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary dystonia group (genetic or idiopathic) | – | Other: No intervention |
| Dystonic cerebral palsy group | – | Other: No intervention |
| Control group | – | Other: No intervention |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Population to be researched is children/young people with dystonia / dystonic cerebral palsy. Age range 5-25 years
Key inclusion criteria (18 listed)
- Age 5 -25 years
- No known disorder of movement
- Able to understand and participate in study.
- Age 5-25 years
- Clinical dystonia - as confirmed on clinical assessment by consultant paediatric neurologist.
Key exclusion criteria (12 listed)
- Age <5 or >25 years
- Any known disorder of movement.
- Age < 5 or >25 years
- Presence of other neurological abnormality in addition to dystonia.
- Abnormal cranial MRI.
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 |
|---|---|---|
| No interventionNo intervention | Other | Control group, Dystonic cerebral palsy group, Primary dystonia group (genetic or idiopathic) |
Primary outcome
Change in mu modulation between trials with and without biofeedback
Time frame: During the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: Yes. The research team will have exclusive use of the data for the project duration and five years afterwards to allow for publications to be achieved. After this period, the majority of data would be made available for data sharing via the King's College London data repository. Only non-identifiable data will be available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dystonia and Dystonic Cerebral Palsy, run by King's College London.
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 18 inclusion and 12 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: opening soon, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mu modulation between trials with and without biofeedback (time frame: During the procedure). 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 10 Nov 2022.