Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome

Learn more about:
Related Clinical Trial
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

Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome

Official Title

Understanding the Anatomy and Physiology of the Sensory Experience and Its Role in Generating Tics in Tourette Syndrome

Brief Summary

      This study will investigate the sensation that many people with Tourette syndrome (TS)
      experience before they have a motor tic. It will also test whether blocking the sensation
      causes the tic to stop.

      People between 18 and 65 years of age with TS who have at least once tic involving an arm may
      be eligible for this 3-part study. Those enrolled may participate in all parts or in part 1
      or part 2. Those who choose to participate in part 3 must first complete part 2. All must
      stop taking medication for TS and any other medication that may affect the brain for at least
      1 week before the study.

      Part 1

      After numbing the skin or muscles of the arm or leg where a pre-tic sensation is experienced,
      the response of the nerves will be tested by asking subjects to rate the strength of the
      sensation after a pinprick and by stimulating the nerves with small electrical shocks. Then,
      over the course of approximately one hour, subjects will report pre-tic sensations while
      their motor tics are counted. The onset of each tic will be identified with EMG, a test using
      electrodes on the skin to indicate the activity of the muscles.

      Part 2

      Subjects brain waves are recorded using magnetoencephalography (MEG) while they are
      experiencing tics andpre-tic sensory experiences. MEG is a test that records magnetic field
      changes produced by brain activity. Subjects sit in a chair under a dome containing magnetic
      field detectors. They watch a clock and report the time a sensory experience starts. Tics are
      recorded with EMG. Later, a standard MRI of the brain (scan using a magnetic field and radio
      waves) is done to see which parts of the brain produced the activity recorded with MEG.

      Part 3

      Repetitive transcranial magnetic stimulation (rTMS) is used to try to stop the pre-tic
      sensations. For TMS, the subject sits in a chair. A wire coil is held on the subject s scalp,
      and a brief electrical current is passed through the coil, creating a magnetic pulse that
      stimulates a region of the brain. The goal of this stimulation is to reduce the sensory
      experience that precedes a tic in one region of the body. During stimulation, the subject
      hears a click and may feel a pulling sensation on the skin under the coil. There may be a
      twitch in the muscles of the face, arm or leg. This study uses a pattern of repeated pulses
      delivered in short bursts. Following each train of pulses, the effect of the stimulation on
      sensation will be tested by asking the subject to rate the strength of a pinprick and of a
      vibration. In addition, the nerves are stimulated with small shocks to evaluate the effect of
      the TMS on nerve activity. To determine the effect of TMS on the pre-tic sensation, subjects
      are asked to watch a clock and report when they are having a sensory experience. The effect
      on motor tics will be evaluated by using EMG to indicate the tics.
    

Detailed Description

      Objectives:

      We will investigate whether the sensory experience that precedes motor tics in Tourette
      syndrome is generated in the peripheral nervous system and whether it may result from altered
      sensory gating, and whether it is necessary to generate motor tics.

      Study Population:

      We will study 100 subjects. Thirty-five individuals with a diagnosis of Tourette syndrome who
      can describe a sensory experience preceding their tics, and 10 who deny a sensory prodrome
      for a total of 45 subjects. We will also study 55 Healthy volunteers ages 18-65..

      Design: A Two-Part Study

      Part I: MEG recording

      We will determine the extent to which CNS responses to tactile and auditory stimuli
      habituate. Subjects will be presented with trains of stimuli, repeated 80 times. At the end
      of each of these blocks, a questionnaire will ascertain the subject s perception of these
      stimuli. CNS responses to the stimuli will be recorded using MEG and analyzed first for
      localization, and then for amplitude and frequency characteristics. Healthy volunteers will
      be included as a control group.

      Part II: rTMS inhibition

      We will test whether the sensory experience is necessary for generating a motor tic. We will
      inhibit the sensory experience using repetitive transcranial magnetic stimulation (rTMS) over
      the cortical region identified by prior and ongoing imaging studies in our group. Low
      intensity rTMS will be applied as a control. Sensory experiences and motor tics will be
      recorded before and after rTMS..

      Staged Study:

      This will be a staged, exploratory study. In phase 1, we will study 20 adult subjects for
      part II. Data analysis of this phase will determine whether the procedures are well-tolerated
      and safe enough to allow for the inclusion of adolescent children, ages 14 and older. Phase 2
      will involve completion of both parts, with 20 subjects each.

      Outcome Measures:

      For part II, the outcome measures will be 1) inhibition of the sensory experience, and 2) the
      relationship between inhibition of sensory and motor phenomena. For part I, the outcome
      measure will be degree of habituation in TS subjects as compared to that in healthy
      volunteers.
    


Study Type

Observational


Primary Outcome

Inhibition of the sensory experience frequency and intensity.

Secondary Outcome

 The relationship between inhibition of sensory and motor experiences; and detecting and localizing an electromagnetic signal corresponding to the sensory experience.

Condition

Tic Disorder



Publications

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

Recruitment Information



Estimated Enrollment

54

Start Date

September 15, 2008

Completion Date

October 25, 2016


Eligibility Criteria

        -  INCLUSION CRITERIA:

        Tourette subjects must be 18-65 years of age of any race, gender, or handedness. They must
        be able to sit for at least 2 hours and remain at the testing site for up to 8 hours. They
        must be able to follow instructions and participate in reporting sensory experiences. The
        upper extremity tic to be studied must occur at least once a minute, but no more frequently
        than once every 5 seconds. Individuals with comorbid attention deficit disorder (ADD or
        ADHD) or with obsessive-compulsive disorder (OCD) will not be excluded.

        Healthy volunteers must be 18-65 years of age, of any race, gender, or handedness.

        EXCLUSION CRITERIA:

          1. Inability to stop taking all central-acting medications, including those used to treat
             tics, for at least one week prior to the study

          2. Current use of coumadin, heparin, or lovenox

          3. Any additional movement disorder, including tremor, myoclonus, or dystonia

          4. A diagnosis of major depression or bipolar disorder

          5. Frequent or severe headaches

          6. Any history of or current experience of hallucinations

          7. Any history of a seizure or epilepsy or a family history of epilespy

          8. Any prior brain injury, brain tumor or other lesion, stroke, or surgery

          9. A diagnosis of increased intracranial pressure

         10. A history of significant heart disease

         11. Any history of hearing problems, or abnormal results on auditory testing (part I or
             II)

         12. Any of the following: pacemakers or other implanted electrical devices, brain
             stimulators, dental implants, aneurysm clips (metal clips on the wall of a large
             artery), metallic prostheses (including metal pins and rods, heart valves, and
             cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments
             (part I and II only)

         13. Any history of work as a welder or metal worker (part I and II)

         14. Current pregnancy

         15. Tobacco use (cigarette, chewing, or other) in the month prior to the study (part II)

         16. Diagnosis of, treatment for, or self-report of alcohol abuse (alcoholism) (part I)

         17. Cocaine use in the year prior to involvement in the study (part I)

         18. Use of any medication within one month prior to the study with cholinergic or
             anticholinergic properties, including (but not limited to): nicotine patch, nicorette
             gum, atrovent, enablex, toriaz, ditropan, vesicare, detrol, sanctura, artane, Aricept,
             cogentin, akineton, zanaflex, norflex, flexeril, lomotil, mototen, levsin, razadyne,
             exelon (part I)

         19. Peripheral neuropathy or carpal tunnel syndrome (part I)

         20. Inability to hold head still for 10 minutes (part I).
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Mark Hallett, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00755339

Organization ID

080215

Secondary IDs

08-N-0215


Study Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)


Study Sponsor

Mark Hallett, M.D., Principal Investigator, National Institute of Neurological Disorders and Stroke (NINDS)


Verification Date

October 25, 2016