Brain Stimulation in Movement Disorders
Condition: Huntington's Disease; Tourette Syndrome
MeSH terms: Huntington Disease; Movement Disorders; Tourette Syndrome
Study type: Interventional

Summary: 
      Brain stimulation in movement disorders

      This trial will explore the effects of very gentle electrical stimulation of the brain in
      patients with movement disorders. Other studies have already been carried out and have shown
      that brain stimulation may help to improve mental abilities and the symptoms of conditions
      such as depression and stroke. The investigators will show whether this method can help with
      symptoms such as memory and concentration problems in patients with movement disorder who
      have mild to moderate problems with these mental abilities. The investigators will also look
      at the effects of brain stimulation on movement symptoms and mood. These people will be
      compared to healthy people to help us understand whether brain stimulation works differently
      in healthy people and people with brain disorders.

      This trial is being carried out at one centre in Birmingham. It is scheduled to begin in
      September 2014 and will last for up to five years. As the study commences it is being funded
      by Birmingham and Solihull Mental Health Foundation Trust and University of Birmingham. The
      investigators plan to recruit up to a maximum of 200 individuals in this study.
    

Detailed description: 
      The procedure does not involve any surgery or hair removal. We simply put a small amount of
      electrode gel on your head and then hold two electrodes on the top of your head for a short
      period of time (15-20 minutes) while they generate a small electrical current. It is quite
      common for participants to feel a tingling or an itch near where the electrode is applied,
      but if so, this usually wears off within a few minutes. Previous research has shown this
      method can occasionally lead to mild side-effects (e.g. headache, nausea, fatigue,
      exacerbation of scalp skin conditions). However, there are no known harmful long term
      effects. The positive benefits of brain stimulation can include improving the functioning of
      the brain for a short while after the stimulation session, in a way that may help with things
      like memory problems. Some people may not notice any change, but an improvement may still be
      detected using tests of complex mental skills including memory tasks. It is also possible
      that mood symptoms (e.g. depressive thoughts) could improve. The study will explore these
      possibilities. Looking at whether brain stimulation can help with health symptoms can help us
      develop new treatments.

      This trial will include patients with two different movement disorders: Tourette syndrome and
      Huntington's disease. In both of these conditions, changes deep within the brain can have a
      knock on effect on higher brain areas important for complex mental abilities, as well as
      brain areas involved in movement control. Participants will be male and female adults (aged
      18-65). Patients will have either Tourette syndrome (as diagnosed according to current
      medical criteria) or Huntington's disease (diagnosed by a genetic test). Patients will have
      few (if any) signs of additional medical conditions. Healthy controls (who will be compared
      to patients) will have no current significant medical or psychiatric diagnoses, history of
      drug use or brain injury.

      There will be least two separate appointments for you to attend the study center. We will
      first assess your mental abilities (e.g. memory, attention) and interview you about current
      mood or medical symptoms. Brain stimulation will be given to slightly different areas of the
      outer part of the brain, near the top and front of the head, for each patient group. You may
      be asked to take part in the trial where there is a no-treatment placebo condition, where the
      procedure will feel similar to real brain stimulation, but real brain stimulation will not
      take place. If you receive the placebo condition you will also receive real stimulation, but
      you will not know which condition is which. This means the effects of expectations are less
      likely to influence the results. After brain stimulation we will take measures of mental
      abilities, and compare them to measures taken before brain stimulation, to show whether brain
      stimulation has had a greater effect on mental abilities than expected by chance.

      You may be asked to complete a simple task (e.g. remembering numbers) while having the brain
      stimulation, as it has been suggested that this could make the effects of stimulation more
      effective in improving mental skills. As the trial continues, some participants will be
      invited to have repeated sessions of stimulation over a few days (e.g. three appointments
      over three days in a row) to look at whether this could make the effects last longer. We will
      record the effects of brain stimulation on participant's mental skills, movement symptoms and
      mood, as well as any side effects. We will collect data about your symptoms and health
      conditions in order to look for relationships between these factors and the effects of brain
      stimulation. Finally, you may be asked to have a brain scan straight after receiving brain
      stimulation, so we can look for any changes in brain activity.
    

Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other