Tourette SyndromeNCT00081419
Timing of Voluntary Movement in Patients With Tourette Syndrome and Chronic Tic Disorder
An observational study of Tourette Syndrome and Tic Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine how the brain controls movement in people with Tourette syndrome and chronic tic disorder to determine if the timing of movement is important in whether someone feels "in control" of their movements. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourette Syndrome, Tic Disorders
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2004to 12 Jan 2009
- 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
- Tic Patients:
- Patients will be men or women, ages 18-65, with a DSM-IV-TR diagnosis of TS or CTD. Patients will be screened in the NINDS Movement Disorders Outpatient Clinic, and will have neurological and physical examinations. They will be asked to abstain from alcohol and any medications for 24 hours before the study. All subjects participating in the studies will have a valid Clinical Center Medical Record Number.
- Normal Volunteers:
- Twenty-six normal controls will be included; controls will be screened in the NINDS Movement Disorders Outpatient Clinic, and will have neurological and physical examinations. They will be asked to abstain from alcohol and any medications for 24 hours before the study. All subjects participating in the studies will have a valid Clinical Center Medical Record Number.
Who cannot join
- Patients younger than 18 years old or older than 65 years old will be excluded from the study.
- Tic Patients:
- Patients with neurological disorders other than TS or CTD
- Patients with Attention deficit hyperactivity disorder (ADHD)
- Patients who are not able to abstain from alcohol or medication affecting the central nervous system for 24 hours before the study
- Patients not capable of giving an informed consent
Show all 10Show fewer
- Normal Subjects:
- Patients with neurological disorders or ADHD
- Patients who are not able to abstain from alcohol or medication affecting the central nervous system for 24 hours before the study
- Patients not capable of giving an informed consent
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: Timing of Voluntary Movement in Patients With Tourette Syndrome and Chronic Tic Disorder Using EEG and Surface EMG
This study will examine how the brain controls movement in people with Tourette syndrome and chronic tic disorder to determine if the timing of movement is important in whether someone feels "in control" of their movements. Although movements in tic disorders are often characterized as "involuntary," some patients claim that these movements are made voluntarily, or they are unable to decide if they are voluntary or involuntary. Previous experiments have shown that when people are asked to look at a clock and report the time they first decide to make a movement they report times later than the first brain waves associated with movement appear. When they are asked to report the time they first initiate the movement, they report times before the muscles actually begin to move. This study may help determine how the sense of willing and initiating an action is altered in patients with Tourette syndrome and chronic tic disorder, and how people may feel more or less "in control" of their movements.
Normal volunteers and patients with Tourette syndrome or chronic tic disorder between 18 and 65 years of age may be eligible for this study. Control subjects must not have any neurological or psychological disorders, and patients with Tourette syndrome of chronic tic disorder must not have any other neurological disorders. Patients with attention deficit hyperactivity disorder (ADHD) may not enroll in this study.
Read more
All participants will have a medical history, physical examination, and a test to determine their level of attention. Patients will be interviewed about their symptoms and complete psychiatric rating scales. In addition, all participants will undergo the following procedures:
Electric shock
Participants look at a clock on a computer screen, the hands of which revolves quickly. While looking at the clock, each participant will be given small, non-painful electric shocks and asked, according to the clock, to say when they received the shocks. The shocks are repeated 40 times.
Arm movement
Participants are asked to lift their arms off a table repeatedly, at random times, while they look at the computer clock. This exercise is repeated 80 times. Of these 80, participants are asked 10 times consecutively to say the time they first had the desire to move their arm, and then 10 consecutively the time they first felt that they were moving their arm.
Electroencephalography (EEG) and Electromyography (EMG)
Participants undergo EEG and EMG durin...
Read the detailed description
OBJECTIVES: The purpose of this study is to determine how the subjective sense of willing and initiating an action is altered in patients with Tourette Syndrome and Chronic Tic Disorder. Although many definitions of the disease include the characterization of tics as 'involuntary', some patients claim that these movements are voluntarily made, or are unable to decide if they are voluntary or involuntary. Recent studies have shown that the time order in which someone wills a voluntary movement and begins that movement is central to the subjective sense of causality. We propose to examine tics as well as normal, voluntary movements in patients with Tourette Syndrome and Chronic Tic Disorder to identify the time course between the decision to move and the onset of movement. Using Libet's paradigm, we intend to have subjects watch a fast-rotating clock to report the times associated with willing (time W) and initiating (time M) movement; we will also determine electroencephalographic/electromyographic (EEG/EMG) measures of movement.
STUDY POPULATION: We intend to study adult patients with a Diagnostic and Statistical Manual of Mental Disorders diagnosis of a tic disorder and frequent tics as well as normal, healthy volunteers as controls.
DESIGN: We will ask tic patients to rate the "voluntariness" of their tics using a rating scale. We will ask tics patients to look at a fast-rotating clock on a computer screen and note when their movements were willed (time W) and were initiated (time M), for tics as well as normal voluntary movements. Patients will also report the time of a somatosensory stimulus. Surface EMG will determine the time of actual movement, and EEG will record brain potentials associated with movement. The design will be the same for the normal volunteers with the exception that the volunteers will not complete rating scales and will not be experiencing tics.
OUTCOME MEASURES: The primary outcome measure of this study is the latency of times W and M (before EMG onset) in tics patients as correlated with the voluntariness the patients associate with their tics, compared to the time W and M reported for normal voluntary movements in the normal volunteers.
- Conditions
- Tourette Syndrome, Tic Disorders
- Keywords
- Bereitschaftspotential, Timing of Volition, Urge, Conscious Will, Libet's Clock, Tourette Syndrome, Tic Disorder, Healthy Volunteer, HV
- Medical subject headings
- Tourette Syndrome, Tic Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2004 (estimated)
- Study start8 Apr 2004
- Study completion12 Jan 2009
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 Tourette SyndromeStudies 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
- Enrolment
- 42 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081419
- Sponsor's protocol ID
- 040153
- Other IDs
- 04-N-0153
- Status last verified
- 12 Jan 2009
- First submitted
- 10 Apr 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Berardelli A, Curra A, Fabbrini G, Gilio F, Manfredi M. Pathophysiology of tics and Tourette syndrome. J Neurol. 2003 Jul;250(7):781-7. doi: 10.1007/s00415-003-1102-4.
PubMed 12883917Goetz CG, Leurgans S, Chmura TA. Home alone: methods to maximize tic expression for objective videotape assessments in Gilles de la Tourette syndrome. Mov Disord. 2001 Jul;16(4):693-7. doi: 10.1002/mds.1159.
PubMed 11481693Gomes G. Problems in the timing of conscious experience. Conscious Cogn. 2002 Jun;11(2):191-97. doi: 10.1006/ccog.2002.0550.
PubMed 12191936
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Voluntary Movement in Patients With Tourette Syndrome and Chronic Tic Disorder Using EEG and Surface EMG
- ClinicalTrials.gov ID
- NCT00081419
- Acronym / sponsor ID
- 040153
- Conditions
- Tourette Syndrome, Tic Disorders
- Keywords
- Bereitschaftspotential, Timing of Volition, Urge, Conscious Will, Libet's Clock, Tourette Syndrome, Tic Disorder, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 8 Apr 2004
- Study completion
- 12 Jan 2009
- First posted
- 12 Apr 2004 (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 examine how the brain controls movement in people with Tourette syndrome and chronic tic disorder to determine if the timing of movement is important in whether someone feels "in control" of their movements. Although movements in tic disorders are often characterized as "involuntary," some patients claim that these movements are made voluntarily, or they are unable to decide if they are voluntary or involuntary. Previous experiments have shown that when people are asked to look at a clock and report the time they first decide to make a movement they report times later than the first brain waves associated with movement appear. When they are asked to report the time they first initiate the movement, they report times before the muscles actually begin to move. This study may help determine how the sense of willing and initiating an action is altered in patients with Tourette syndrome and chronic tic disorder, and how people may feel more or less "in control" of their movements.
Normal volunteers and patients with Tourette syndrome or chronic tic disorder between 18 and 65 years of age may be eligible for this study. Control subjects must not have any neurological or psychological disorders, and patients with Tourette syndrome of chronic tic disorder must not have any other neurological disorders. Patients with attention deficit hyperactivity disorder (ADHD) may not enroll in this study.
All participants will have a medical history, physical examination, and a test to determine their level of attention. Patients will be interviewed about their symptoms and complete psychiatric rating scales. In addition, all participants will undergo the following procedures:
Electric shock
Participants look at a clock on a computer screen, the hands of which revolves quickly. While looking at the clock, each participant will be given small, non-painful electric shocks and asked, according to the clock, to say when they received the shocks. The shocks are repeated 40 times.
Arm movement
Participants are asked to lift their arms off a table repeatedly, at random times, while they look at the computer clock. This exercise is repeated 80 times. Of these 80, participants are asked 10 times consecutively to say the time they first had the desire to move their arm, and then 10 consecutively the time they first felt that they were moving their arm.
Electroencephalography (EEG) and Electromyography (EMG)
Participants undergo EEG and EMG durin...
Detailed description
OBJECTIVES: The purpose of this study is to determine how the subjective sense of willing and initiating an action is altered in patients with Tourette Syndrome and Chronic Tic Disorder. Although many definitions of the disease include the characterization of tics as 'involuntary', some patients claim that these movements are voluntarily made, or are unable to decide if they are voluntary or involuntary. Recent studies have shown that the time order in which someone wills a voluntary movement and begins that movement is central to the subjective sense of causality. We propose to examine tics as well as normal, voluntary movements in patients with Tourette Syndrome and Chronic Tic Disorder to identify the time course between the decision to move and the onset of movement. Using Libet's paradigm, we intend to have subjects watch a fast-rotating clock to report the times associated with willing (time W) and initiating (time M) movement; we will also determine electroencephalographic/electromyographic (EEG/EMG) measures of movement.
STUDY POPULATION: We intend to study adult patients with a Diagnostic and Statistical Manual of Mental Disorders diagnosis of a tic disorder and frequent tics as well as normal, healthy volunteers as controls.
DESIGN: We will ask tic patients to rate the "voluntariness" of their tics using a rating scale. We will ask tics patients to look at a fast-rotating clock on a computer screen and note when their movements were willed (time W) and were initiated (time M), for tics as well as normal voluntary movements. Patients will also report the time of a somatosensory stimulus. Surface EMG will determine the time of actual movement, and EEG will record brain potentials associated with movement. The design will be the same for the normal volunteers with the exception that the volunteers will not complete rating scales and will not be experiencing tics.
OUTCOME MEASURES: The primary outcome measure of this study is the latency of times W and M (before EMG onset) in tics patients as correlated with the voluntariness the patients associate with their tics, compared to the time W and M reported for normal voluntary movements in the normal volunteers.
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients will be men or women, ages 18-65, with a DSM-IV-TR diagnosis of TS or CTD. Patients will be screened in the NINDS Movement Disorders Outpatient Clinic, and will have neurological and physical examinations. They will be asked to abstain from alcohol and any medications for 24 hours before the study. All subjects participating in the studies will have a valid Clinical Center Medical Record Number.
- Twenty-six normal controls will be included; controls will be screened in the NINDS Movement Disorders Outpatient Clinic, and will have neurological and physical examinations. They will be asked to abstain from alcohol and any medications for 24 hours before the study. All subjects participating in the studies will have a valid Clinical Center Medical Record Number.
Key exclusion criteria (10 listed)
- Patients younger than 18 years old or older than 65 years old will be excluded from the study.
- Patients with neurological disorders other than TS or CTD
- Patients with Attention deficit hyperactivity disorder (ADHD)
- Patients who are not able to abstain from alcohol or medication affecting the central nervous system for 24 hours before the study
- Patients not capable of giving an informed consent
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
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 12883917Berardelli A, Curra A, Fabbrini G, Gilio F, Manfredi M. Pathophysiology of tics and Tourette syndrome. J Neurol. 2003 Jul;250(7):781-7. doi: 10.1007/s00415-003-1102-4.
- Background: PubMed 11481693Goetz CG, Leurgans S, Chmura TA. Home alone: methods to maximize tic expression for objective videotape assessments in Gilles de la Tourette syndrome. Mov Disord. 2001 Jul;16(4):693-7. doi: 10.1002/mds.1159.
- Background: PubMed 12191936Gomes G. Problems in the timing of conscious experience. Conscious Cogn. 2002 Jun;11(2):191-97. doi: 10.1006/ccog.2002.0550.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tourette Syndrome and Tic Disorders, 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 4 inclusion and 10 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 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00081419, 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 2 Jul 2017.