Brain Stimulation in Movement Disorders

Learn more about:
Related Clinical Trial
Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics Internet-based Cognitive Behavioral Therapy for Chronic Tic Disorder and Tourette’s Disorder: a Feasibility Trial Longitudinal Impact of Stressors in Adults With Tourette Syndrome Effects of Lactobacillus Plantarum PS128 in Patients With Tourette’s Syndrome Combined CBIT and rTMS to Improve Tourette’s Syndrome Pimavanserin Treatment in TS Median Nerve Stimulation (MNS) Pilot Extinction Learning in Adults With Tourette Syndrome Observational Database on Deep Brain Stimulation in Tourette Syndrome Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome D-cycloserine Augmented Treatment for Youth With Tic Disorders Sensory Symptoms in Tourette Syndrome and Obsessive-Compulsive Disorder Atomoxetine in Patients With Tourette’s Syndrome Deep Brain Stimulation in Forel’s H Field in Tourette’s Syndrome Psychosocial Intervention for Young Children With Chronic Tics Brain Tissue Collection for Neuropathological Studies New Stereotactic Frame System for Neurosurgery Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders. Outcomes Mandate National Integration With Cannabis as Medicine Reliability and Validity of the MINI International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) Brain-Behavior Interactions in Tic Suppression Phase III Study of 5LGr to Treat Tic Disorder Effects of Ondansetron in Obsessive-compulsive and Tic Disorders I-123 Brain Studies of Serotonin Metabolism in Psychiatric Patients and Normal Volunteers Physiological Investigations of Movement Disorders Dissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists: A Feasibility Study TicHelper: A Computerized Comprehensive Behavioral Intervention for Tics (CBIT) Safety Study of Galantamine in Tic Disorders Internet-based Coaching for Young Adults With Neuropsychiatric Disorders Modified Comprehensive Behavioral Intervention for Tics (M_CBIT) Incorporating teleCBIT Into a Hospital-Based Tic Program Cognitive Behavior Therapy and Habit Reversal Training for the Treatment of Chronic Tic Disorders in Children An Exploratory Study of Transcranial Magnetic Stimulation (TMS) Based on Functional Magnetic Resonance Imaging (fMRI) in the Treatment of Tic Disorder Brain Stimulation in Movement Disorders Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo Central Mechanisms in Speech Motor Control Studied With H215O PET Comparison of Keppra and Clonidine in the Treatment of Tics Brain Activation in Vocal and Motor Tics Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders Assessment of Children With Tic Onset in the Past 6 Months Repetitive Transcranial Magnetic Stimulation to Reduce Tics Guanfacine in Children With Tic Disorders Neuropsychological Functioning Among Children With Tourret’s Disorder and ADHD Investigating Circadian Rhythms in Youth With Persistent Tic Disorders The Role of Probiotics PS128 in Movement Disorders Online Mindfulness-based Tic Reduction (Phase Two) Online Mindfulness-based Tic Reduction Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders A Handwriting Intervention Program for Children With Tic Disorders Study of Clonidine on Sleep Architecture in Children With Tourette’s Syndrome (TS) and Comorbid ADHD National Gilles De La Tourette Study Group Evaluating the Efficacy and Safety of Yi-Gan San in Children and Adolescents With Tourette’s Disorder Evaluation of a Cognitive Psychophysiological Treatment for Tourette Syndrome and Tic Disorders Magnetic Resonance Spectroscopy to Evaluate Tourette s Syndrome Group Intervention for Children With Chronic Tics Syndrome or Tourette Syndrome: CBIT vs Psycho-Educational Intervention Study of the Neurobiology of Tourette Syndrome and Related Disorders Brain Dynamics Involved in Generating Tics and Controlling Voluntary Movement Dopaminergic Effects on Cortical Function in Tourette’s (Levodopa Protocol) Developmental Phenomenology of Obsessive Compulsive Disorder and Tourette Syndrome in Children and Adolescents Online Remote Behavioural Intervention for Tics (ORBIT) CANNAbinoids in the Treatment of TICS (CANNA-TICS) A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome Internet-delivered Behaviour Therapy for Children and Adolescents With Tourette’s Disorder A Study to Evaluate the Effects of ABX-1431 on Patients With Tourette Syndrome Aripiprazole in the Treatment of Tourette’s Syndrome Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette’s Disorder Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder Randomized Study of Pergolide in Children With Tourette Syndrome Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome tDCS in Tourette (TIC-TDCS) Anger Control Training for Youth With Tourette Syndrome Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome Neurofeedback for Tourette Syndrome Brain Stimulation for the Treatment of Tourette Syndrome Study of Tics in Patients With Tourette’s Syndrome and Chronic Motor Tic Disorder Timing of Voluntary Movement in Patients With Tourette Syndrome and Chronic Tic Disorder Repetitive Transcranial Magnetic Stimulation of the Posterior Parietal Cortex in Patients Suffering From Gilles de la Tourette Syndrome Methylphenidate for Treating Children With ADHD and Tourette Syndrome Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Tourette Syndrome and Seasonality (Stagionalità Tourette) Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents Multi-site Transcranial Magnetic Stimulation Therapy of the Supplementary Motor Area in Children With Tourette Syndrome Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome A Randomized, Placebo-controlled, Tourette Syndrome Study. A Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Tourette Syndrome A Study of the Effectiveness and Safety of Tetrabenazine MR in Pediatric Subjects With Tourette’s Syndrome An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome. Thalamic Deep Brain Stimulation for Tourette Syndrome Exploration of Glutamatergic System With PET Radiotracer in Gilles de la Tourette Patients: Pilot Study (GlutaTour) ABF Tourette’s Disorder Post Marketing Surveillance Study Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome Brain Activity Associated With Tics in Patients With Tourette Syndrome Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome Internet-based Behaviour Therapy for Tourette’s Disorder and Chronic Tic Disorder Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria Response Inhibition in Tourette Syndrome Alternatives for Reducing Tics in TS: A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents. Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome Pallidal Stimulation and Gilles de la Tourette Syndrome Developing New Treatments for Tourette Syndrome: Therapeutic Trials With Modulators of Glutamatergic Neurotransmission Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device – Safety and Feasibility Study for the Treatment of Tourette Syndrome Pilot Study of the Modified Atkins Diet for Tourette Syndrome Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Subjects With Tourette’s Disorder Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome Pilot Study for Use of Dysport in Treatment of Vocal Tics in Patients With Tourette’s Syndrome A Study to Examine the Efficacy of a Therapeutic THX-110 for Tourette Syndrome Open Label Trial of Aripiprazole in Children and Adolescents With Tourette’s Disorder Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome Study Evaluating The Safety And Efficacy Of PF-03654746 In Adult Subjects With Tourette’s Syndrome Safety & Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Hypersensitivity in Tourette Syndrome Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS) Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome VoIP Delivered Behavior Therapy for Tourette Syndrome Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome Study of ABX-1431 in Adult Patients With Tourette Syndrome or Chronic Motor Tic Disorder Subthalamic Stimulation in Tourette’s Syndrome Study of GABA-A Receptors in the Generation of Tics in Patients With Tourette’s Syndrome Transcranial Magnetic Stimulation (TMS) for Individuals With Tourette’s Syndrome Neural Correlates of Sensory Phenomena in Tourette Syndrome Sensory Symptoms in Tourette Syndrome Tourette Syndrome Deep Brain Stimulation The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome Safety, Tolerability, Pharmacokinetic, and Efficacy Study of AZD5213 in Adolescents With Tourette’s Disorder Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Tourette’s Syndrome Facial Expression Recognition of Emotion and Categorization of Emotional Words in Gilles de la Tourette’s Syndrome Thalamic Deep Brain Stimulation for Tourette Syndrome Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome The Effect and Safety of Plum-blossom Needle for Tourette Syndrome Proof-of-Concept Safety Study of CPP-109 (Vigabatrin) for Treatment Refractory Tourette’s Disorder Ecopipam Treatment of Tourette Syndrome High Frequency Stimulation of the GPi or Thalamus in Tourette’s Syndrome Computerized Working Memory Training in Children With ADHD and Comorbid Tourette Syndrome Optimising Anterior Pallidal Deep Brain Stimulation for Tourette’s Syndrome MRI Study of Tic Remission in Tourette Syndrome Thalamic Deep Brain Stimulation for the Treatment of Refractory Tourette Syndrome Selective Microbiota Transplantation for Tourette’s Syndrome Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome (TS) Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study Developing Cognitive Training for Tourette Syndrome A Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of SNC-102 in Subjects With Tourette Syndrome Safety and Efficacy of Cannabis in Tourette Syndrome Activity in Tourette Syndrome FAAH Inhibitor Trial for Adults With Tourette Syndrome Open-Trial of EPI-743 for Adults With Tourette Syndrome Omega-3 Fatty Acids in Tourette’s Disorder Do Mirror Neurons Play a Role in Tourette Syndrome Physiopathology? A Pilot Study. Apathy in Tourette Syndrome and Changes in Quality of Life Sensory Processing in Tourette Syndrome The Pathophysiology of Tourette Syndrome: a Multimodal Study Behavioral Therapy for Tourette Syndrome Behavioral Therapy for Children and Adolescents With Tourette Syndrome Ecopipam Treatment of Tourette’s Syndrome in Subjects 7-17 Years Transcranial Magnetic Stimulation for Children With Tourette’s Syndrome

Brief Title

Brain Stimulation in Movement Disorders

Official Title

Brain Stimulation in Movement Disorders

Brief 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.
    


Study Type

Interventional


Primary Outcome

Change in cognitive function (working memory, response inhibition)

Secondary Outcome

 Change in motor symptom severity (tics/chorea)

Condition

Huntington's Disease

Intervention

Transcranial direct current stimulation

Study Arms / Comparison Groups

 Sham transcranial direct current stimulation (frontal cortex)
Description:  Transcranial direct current stimulation will be ramped up over 60 seconds and then ramped down gradually to encourage blinding to condition.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

20

Start Date

September 2014

Completion Date

September 2019

Primary Completion Date

September 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Patients will have either Tourette syndrome (TS) diagnosed according to Diagnostic and
             Statistical Manual of Mental Disorders criteria or Huntington's disease (HD) diagnosed
             genetically

          -  Controls will be generally healthy individuals not taking any psychoactive medications
             and without diagnosed psychiatric or serious medical conditions (e.g. history of
             seizures, heart disease, head injury)

          -  18-65 years of age for TS; 40-65 years of age for HD; 18-65 for controls

          -  English as a first language

        Exclusion Criteria:

          -  No current significant co-morbid psychiatric disorder (e.g. learning disability,
             schizophrenia) or medical condition which may contraindicate brain stimulation or
             magnetic resonance imaging (e.g. epilepsy, chronic heart disease, scalp skin
             conditions, metal skull implants). Mild symptoms of obsessive compulsive disorder,
             attention deficit hyperactivity disorder and/or mood disorders will be accepted as
             these are very common

          -  No contraindications to MRI scanning (if they will be scanned) such as metal in the
             body, claustrophobia or seizure history

          -  No complex medication regimes (e.g. combinations of multiple dopaminergic drugs plus
             selective serotonin reuptake inhibitors
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT02216474

Organization ID

14/WM/0119-NRR1301


Responsible Party

Sponsor

Study Sponsor

Birmingham and Solihull Mental Health NHS Foundation Trust

Collaborators

 University of Birmingham

Study Sponsor

, , 


Verification Date

January 2020