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NCT Number: NCT05612464

Enhancing Sensorimotor Processing in Children With Dystonia

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key inclusion criteria

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
  • 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.

Key exclusion criteria

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.
  • 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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Change in mu modulation between trials with and without biofeedback

    Time frame: During the procedure

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Barts & The London NHS Trust
  • Guy's and St Thomas' NHS Foundation Trust
  • Imperial College London
  • University of Bristol
  • University of Calgary

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Nov 10, 2022
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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