Tic DisorderNCT00755339
Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome
An observational study of Tic Disorder and Tourette Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tic Disorder, Tourette Syndrome
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2008to 25 Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to stop taking all central-acting medications, including those used to treat tics, for at least one week prior to the study
- Current use of coumadin, heparin, or lovenox
- Any additional movement disorder, including tremor, myoclonus, or dystonia
- A diagnosis of major depression or bipolar disorder
- Frequent or severe headaches
- Any history of or current experience of hallucinations
Show all 20Show fewer
- Any history of a seizure or epilepsy or a family history of epilespy
- Any prior brain injury, brain tumor or other lesion, stroke, or surgery
- A diagnosis of increased intracranial pressure
- A history of significant heart disease
- Any history of hearing problems, or abnormal results on auditory testing (part I or II)
- 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)
- Any history of work as a welder or metal worker (part I and II)
- Current pregnancy
- Tobacco use (cigarette, chewing, or other) in the month prior to the study (part II)
- Diagnosis of, treatment for, or self-report of alcohol abuse (alcoholism) (part I)
- Cocaine use in the year prior to involvement in the study (part I)
- 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)
- Peripheral neuropathy or carpal tunnel syndrome (part I)
- Inability to hold head still for 10 minutes (part I).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Understanding the Anatomy and Physiology of the Sensory Experience and Its Role in Generating Tics in Tourette Syndrome
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.
Read more
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.
Read the 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:<TAB>
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.
- Conditions
- Tic Disorder, Tourette Syndrome
- Keywords
- Repetitive TMS (rTMS), Magnetoencephalogram, Transcranial Magnetic Stimulation (TMS), Tourette Syndrome, Tic Disorder, Tourete Syndrome
- Medical subject headings
- Tic Disorders, Tourette Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition of the sensory experience frequency and intensity.
Secondary outcomes (1)
The relationship between inhibition of sensory and motor experiences; and detecting and localizing an electromagnetic signal corresponding to the sensory experience.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study start15 Sep 2008
- Study completion25 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tic DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755339
- Sponsor's protocol ID
- 080215
- Other IDs
- 08-N-0215
- Status last verified
- 25 Oct 2016
- First submitted
- 17 Sep 2008
- Last updated
- 25 Oct 2019
- Results posted
- No
Publications
Aoki KR. Review of a proposed mechanism for the antinociceptive action of botulinum toxin type A. Neurotoxicology. 2005 Oct;26(5):785-93. doi: 10.1016/j.neuro.2005.01.017. Epub 2005 Jul 5.
PubMed 16002144Alary F, Simoes C, Jousmaki V, Forss N, Hari R. Cortical activation associated with passive movements of the human index finger: an MEG study. Neuroimage. 2002 Mar;15(3):691-6. doi: 10.1006/nimg.2001.1010.
PubMed 11848712Banaschewski T, Woerner W, Rothenberger A. Premonitory sensory phenomena and suppressibility of tics in Tourette syndrome: developmental aspects in children and adolescents. Dev Med Child Neurol. 2003 Oct;45(10):700-3. doi: 10.1017/s0012162203001294.
PubMed 14515942
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Anatomy and Physiology of the Sensory Experience and Its Role in Generating Tics in Tourette Syndrome
- ClinicalTrials.gov ID
- NCT00755339
- Acronym / sponsor ID
- 080215
- Conditions
- Tic Disorder, Tourette Syndrome
- Keywords
- Repetitive TMS (rTMS), Magnetoencephalogram, Transcranial Magnetic Stimulation (TMS), Tourette Syndrome, Tic Disorder, Tourete Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 15 Sep 2008
- Study completion
- 25 Oct 2016
- First posted
- 18 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:<TAB>
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (20 listed)
- Inability to stop taking all central-acting medications, including those used to treat tics, for at least one week prior to the study
- Current use of coumadin, heparin, or lovenox
- Any additional movement disorder, including tremor, myoclonus, or dystonia
- A diagnosis of major depression or bipolar disorder
- Frequent or severe headaches
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inhibition of the sensory experience frequency and intensity.
1 secondary outcome
The relationship between inhibition of sensory and motor experiences; and detecting and localizing an electromagnetic signal corresponding to the sensory experience.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Background: PubMed 16002144Aoki KR. Review of a proposed mechanism for the antinociceptive action of botulinum toxin type A. Neurotoxicology. 2005 Oct;26(5):785-93. doi: 10.1016/j.neuro.2005.01.017. Epub 2005 Jul 5.
- Background: PubMed 11848712Alary F, Simoes C, Jousmaki V, Forss N, Hari R. Cortical activation associated with passive movements of the human index finger: an MEG study. Neuroimage. 2002 Mar;15(3):691-6. doi: 10.1006/nimg.2001.1010.
- Background: PubMed 14515942Banaschewski T, Woerner W, Rothenberger A. Premonitory sensory phenomena and suppressibility of tics in Tourette syndrome: developmental aspects in children and adolescents. Dev Med Child Neurol. 2003 Oct;45(10):700-3. doi: 10.1017/s0012162203001294.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Hallett, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tic Disorder and Tourette Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhibition of the sensory experience frequency and intensity.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00755339, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019.