<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02216474</url>
  </required_header>
  <id_info>
    <org_study_id>14/WM/0119-NRR1301</org_study_id>
    <nct_id>NCT02216474</nct_id>
  </id_info>
  <brief_title>Brain Stimulation in Movement Disorders</brief_title>
  <official_title>Brain Stimulation in Movement Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Birmingham and Solihull Mental Health NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Birmingham and Solihull Mental Health NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Brain stimulation in movement disorders&#xD;
&#xD;
      This trial will explore the effects of very gentle electrical stimulation of the brain in&#xD;
      patients with movement disorders. Other studies have already been carried out and have shown&#xD;
      that brain stimulation may help to improve mental abilities and the symptoms of conditions&#xD;
      such as depression and stroke. The investigators will show whether this method can help with&#xD;
      symptoms such as memory and concentration problems in patients with movement disorder who&#xD;
      have mild to moderate problems with these mental abilities. The investigators will also look&#xD;
      at the effects of brain stimulation on movement symptoms and mood. These people will be&#xD;
      compared to healthy people to help us understand whether brain stimulation works differently&#xD;
      in healthy people and people with brain disorders.&#xD;
&#xD;
      This trial is being carried out at one centre in Birmingham. It is scheduled to begin in&#xD;
      September 2014 and will last for up to five years. As the study commences it is being funded&#xD;
      by Birmingham and Solihull Mental Health Foundation Trust and University of Birmingham. The&#xD;
      investigators plan to recruit up to a maximum of 200 individuals in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The procedure does not involve any surgery or hair removal. We simply put a small amount of&#xD;
      electrode gel on your head and then hold two electrodes on the top of your head for a short&#xD;
      period of time (15-20 minutes) while they generate a small electrical current. It is quite&#xD;
      common for participants to feel a tingling or an itch near where the electrode is applied,&#xD;
      but if so, this usually wears off within a few minutes. Previous research has shown this&#xD;
      method can occasionally lead to mild side-effects (e.g. headache, nausea, fatigue,&#xD;
      exacerbation of scalp skin conditions). However, there are no known harmful long term&#xD;
      effects. The positive benefits of brain stimulation can include improving the functioning of&#xD;
      the brain for a short while after the stimulation session, in a way that may help with things&#xD;
      like memory problems. Some people may not notice any change, but an improvement may still be&#xD;
      detected using tests of complex mental skills including memory tasks. It is also possible&#xD;
      that mood symptoms (e.g. depressive thoughts) could improve. The study will explore these&#xD;
      possibilities. Looking at whether brain stimulation can help with health symptoms can help us&#xD;
      develop new treatments.&#xD;
&#xD;
      This trial will include patients with two different movement disorders: Tourette syndrome and&#xD;
      Huntington's disease. In both of these conditions, changes deep within the brain can have a&#xD;
      knock on effect on higher brain areas important for complex mental abilities, as well as&#xD;
      brain areas involved in movement control. Participants will be male and female adults (aged&#xD;
      18-65). Patients will have either Tourette syndrome (as diagnosed according to current&#xD;
      medical criteria) or Huntington's disease (diagnosed by a genetic test). Patients will have&#xD;
      few (if any) signs of additional medical conditions. Healthy controls (who will be compared&#xD;
      to patients) will have no current significant medical or psychiatric diagnoses, history of&#xD;
      drug use or brain injury.&#xD;
&#xD;
      There will be least two separate appointments for you to attend the study center. We will&#xD;
      first assess your mental abilities (e.g. memory, attention) and interview you about current&#xD;
      mood or medical symptoms. Brain stimulation will be given to slightly different areas of the&#xD;
      outer part of the brain, near the top and front of the head, for each patient group. You may&#xD;
      be asked to take part in the trial where there is a no-treatment placebo condition, where the&#xD;
      procedure will feel similar to real brain stimulation, but real brain stimulation will not&#xD;
      take place. If you receive the placebo condition you will also receive real stimulation, but&#xD;
      you will not know which condition is which. This means the effects of expectations are less&#xD;
      likely to influence the results. After brain stimulation we will take measures of mental&#xD;
      abilities, and compare them to measures taken before brain stimulation, to show whether brain&#xD;
      stimulation has had a greater effect on mental abilities than expected by chance.&#xD;
&#xD;
      You may be asked to complete a simple task (e.g. remembering numbers) while having the brain&#xD;
      stimulation, as it has been suggested that this could make the effects of stimulation more&#xD;
      effective in improving mental skills. As the trial continues, some participants will be&#xD;
      invited to have repeated sessions of stimulation over a few days (e.g. three appointments&#xD;
      over three days in a row) to look at whether this could make the effects last longer. We will&#xD;
      record the effects of brain stimulation on participant's mental skills, movement symptoms and&#xD;
      mood, as well as any side effects. We will collect data about your symptoms and health&#xD;
      conditions in order to look for relationships between these factors and the effects of brain&#xD;
      stimulation. Finally, you may be asked to have a brain scan straight after receiving brain&#xD;
      stimulation, so we can look for any changes in brain activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">September 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cognitive function (working memory, response inhibition)</measure>
    <time_frame>From baseline to five minutes after brain stimulation and from baseline to two weeks after stimulation (follow-up)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in motor symptom severity (tics/chorea)</measure>
    <time_frame>From baseline to five minutes after brain stimulation and from baseline to two weeks after stimulation (follow-up)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood change (anxiety and depression questionnaire scores)</measure>
    <time_frame>From baseline to five minutes after brain stimulation and from baseline to two weeks after stimulation (follow-up)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Huntington's Disease</condition>
  <condition>Tourette Syndrome</condition>
  <arm_group>
    <arm_group_label>Sham transcranial direct current stimulation (frontal cortex)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Transcranial direct current stimulation will be ramped up over 60 seconds and then ramped down gradually to encourage blinding to condition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anodal transcranial DC stimulation (frontal cortex)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anodal transcranial direct current stimulation to prefrontal cortex for approximately 15 minutes plus ramp up and down time</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transcranial direct current stimulation</intervention_name>
    <arm_group_label>Anodal transcranial DC stimulation (frontal cortex)</arm_group_label>
    <arm_group_label>Sham transcranial direct current stimulation (frontal cortex)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients will have either Tourette syndrome (TS) diagnosed according to Diagnostic and&#xD;
             Statistical Manual of Mental Disorders criteria or Huntington's disease (HD) diagnosed&#xD;
             genetically&#xD;
&#xD;
          -  Controls will be generally healthy individuals not taking any psychoactive medications&#xD;
             and without diagnosed psychiatric or serious medical conditions (e.g. history of&#xD;
             seizures, heart disease, head injury)&#xD;
&#xD;
          -  18-65 years of age for TS; 40-65 years of age for HD; 18-65 for controls&#xD;
&#xD;
          -  English as a first language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No current significant co-morbid psychiatric disorder (e.g. learning disability,&#xD;
             schizophrenia) or medical condition which may contraindicate brain stimulation or&#xD;
             magnetic resonance imaging (e.g. epilepsy, chronic heart disease, scalp skin&#xD;
             conditions, metal skull implants). Mild symptoms of obsessive compulsive disorder,&#xD;
             attention deficit hyperactivity disorder and/or mood disorders will be accepted as&#xD;
             these are very common&#xD;
&#xD;
          -  No contraindications to MRI scanning (if they will be scanned) such as metal in the&#xD;
             body, claustrophobia or seizure history&#xD;
&#xD;
          -  No complex medication regimes (e.g. combinations of multiple dopaminergic drugs plus&#xD;
             selective serotonin reuptake inhibitors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Neuropsychiatry, BSMHFT The Barberry</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 2FG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>January 21, 2020</last_update_submitted>
  <last_update_submitted_qc>January 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Huntington Disease</mesh_term>
    <mesh_term>Movement Disorders</mesh_term>
    <mesh_term>Tourette Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02216474
org study id: 14/WM/0119-NRR1301
nct id: NCT02216474
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Change in cognitive function (working memory, response inhibition)
time frame: From baseline to five minutes after brain stimulation and from baseline to two weeks after stimulation (follow-up)
measure: Change in motor symptom severity (tics/chorea)
time frame: From baseline to five minutes after brain stimulation and from baseline to two weeks after stimulation (follow-up)
measure: Mood change (anxiety and depression questionnaire scores)
time frame: From baseline to five minutes after brain stimulation and from baseline to two weeks after stimulation (follow-up)
arm group label: Sham transcranial direct current stimulation (frontal cortex)
arm group type: Sham Comparator
description: Transcranial direct current stimulation will be ramped up over 60 seconds and then ramped down gradually to encourage blinding to condition.
arm group label: Anodal transcranial DC stimulation (frontal cortex)
arm group type: Experimental
description: Anodal transcranial direct current stimulation to prefrontal cortex for approximately 15 minutes plus ramp up and down time
intervention type: Other
intervention name: Transcranial direct current stimulation
arm group label: Anodal transcranial DC stimulation (frontal cortex)
arm group label: Sham transcranial direct current stimulation (frontal cortex)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Huntington Disease
mesh term: Movement Disorders
mesh term: Tourette Syndrome