Tourette SyndromeNCT00056420
Brain Dynamics Involved in Generating Tics and Controlling Voluntary Movement
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 use electroencephalography (EEG) and electromyography (EMG) to examine how the brain generates tics and controls voluntary movement in patients with Tourette's syndrome and chronic motor tic disorder. EEG records the electrical activity of the brain. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourette Syndrome, Tic Disorders
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2003to 22 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HEALTHY VOLUNTEERS:
- Healthy volunteers are between the ages of 21 and 65 years.
- PATIENTS:
- Patients will have clinically documented Tourette's syndrome or chronic motor tic disorder as defined by DSM-IV-TR and evaluation of tic severity using the Yale Tic Scale. This criterion will be established by preliminary screening in the NINDS Movement Disorders Outpatient Clinic. Regarding co-morbid disorders such as ADHD and OCD, we will accept a mild degree of ADHD and mild to moderate degree of OCD. These disorders will be established by a psychiatrist using below listed scales and criteria.
- Structure Clinical Interview for (DSMIV SCID) will be administered to all subjects to ensure that strict DSM-IV criteria for Tourette Syndrome have been met and to assess for possible comorbid psychiatric disorders.
- Given the high rate of comorbidity of Obsessive Compulsive Disorder (OCD) and Attention Deficit/Hyperactivity Disorder (ADHD) in Tourette's syndrome, it may not be possible to exclude persons with these disorders. Hence, only those with no more than mild to moderate severity of symptoms will be accepted into the study. This will be ascertained using the following instruments and their respective cut-off scores:
Show all 16Show fewer
- Y-BOCS (Goodman et al, 1989) a 10 item scale with a range of 0 - 4 and maximum possible score of 40 (0-7: subclinical; 8 - 15: mild; 16 -23: moderate; 24 - 31 severe; 32 - 40: extreme). Inclusion criteria: 23 or below.
- ADHD Behavior Checklist for Adults (Barkley, 1995, Murphy and Barkley, 1995): An 18 Item checklist with 9 Inattention items and 9 Hyperactive/impulsive items ranging 0 - 3 (0: never or rarely 1: sometimes 2: often and 3: very often ). Items answered often or very often are scored as present. With age, the threshold criterion for presence of ADHD become lower and is currently accepted as follows:
- Age Range; Inattention Items; Hyperactive and Impulsive Items respectively:
- 21-29 years; 4 of 9; 5 of 9
- 30-49; 4 of 9; 4 of 9
- 50 and over; 3 of 9; 3 of 9
- Age Range; Inattention Items; Hyperactive and Impulsive Items respectively:
- 21-29 years; 3 or below; 4 or below
- 30-49; 3 or below; 3 or below
- 50 and over; 2 or below; 2 or below
Who cannot join
- The following subjects will be excluded from the study:
- Subjects younger than 21 or older than 65 years, as EEG studies have shown findings to vary with neurodevelopment and age.
- Subjects with 1) major depression, 2) bipolar disorder, or 3) psychotic disorder. Such coexisting neuropsychiatric disorders may lead to unnecessary confounds of the data.
- Subjects taking benzodiazepines, anti-depressant or neuroleptic medications (such medications are known to affect EEG and may thus confound data)
- Subjects with major acute or chronic illness (experimental setting may be unnecessarily uncomfortable or unpleasant)
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: Spatiotemporal Dynamics of Cortical Connectivity Involved in Tics and Voluntary Movements in Patients With Tourette's Syndrome and Chronic Motor Tic Disorder: An EEG Study
This study will use electroencephalography (EEG) and electromyography (EMG) to examine how the brain generates tics and controls voluntary movement in patients with Tourette's syndrome and chronic motor tic disorder. EEG records the electrical activity of the brain. For this test, a cap with built-in electrodes is placed on the subject's head, and the electrodes are connected to a monitor that records the brain activity. EMG records muscle activity using electrodes placed on the skin over muscles on the fingers or above the outer corner of the eyes.
Healthy normal volunteers and patients with Tourette's syndrome and chronic motor tic disorder between 21 and 65 years of age may be eligible for this 2- to 3-hour study. Each candidate will be screened with a medical history, physical and neurological examinations, and a questionnaire that screens for psychiatric disorders.
Read more
During EEG and EMG recordings, participants undergo the following tasks while seated comfortably in a sound-shielded room:
Patients
- Finger task: Patients raise their index finger once every 10 seconds for about 25 minutes.
- Tic evaluation and mimicking: Patients allow their tics to occur as they do naturally. After each tic, they report whether the tic was voluntary and whether it was preceded by a sensation of urge. They then mimic tics that they normally have, at a rate of about once every 10 seconds.
- Tic suppression task: Patients suppress tics they normally have for several minutes. They then allow the tics to occur naturally, without attempting to suppress them.
Normal Volunteers
- Finger task: Volunteers raise their index finger once every 10 seconds for about 25 minutes.
- Open eye task: Volunteers keep their eyes open for a minute or so, and then resume blinking as often as feels comfortable. The process is repeated several times.
Read the detailed description
This study examines the spatiotemporal dynamics of cortical functional interconnectivity involved tics and voluntary movement in patients with Tourette's syndrome or chronic motor tic disorder. By employing a combination of EEG methods that utilize analyses in the domains of both frequency (e.g., event-related desynchronization/synchronization (ERD/ERS), event-related partial coherence, phase coherence) and time (e.g., event-related partial correlation), we intend to determine
- Whether the cortical neurocircuitry involved in the performance of a simple, voluntary motor task differs in patients with tic disorders from that of healthy volunteers;
- Whether the network involved in the generation of unwanted tics differs from that of normal voluntary movement (i.e., mimicked tics); and
- What role, if any, premonitory urge and/or tic suppression plays in the modulation of this neurocircuitry.
- Conditions
- Tourette Syndrome, Tic Disorders
- Keywords
- Tourette's Syndrome, Tic Disorder, (EEG) Electroencephalography, Event-Related Desynchronization/Synchronization, Coherence, Tourette's, Tourette Syndrome, 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 posted13 Mar 2003 (estimated)
- Study start10 Mar 2003
- Study completion22 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.
- 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
- 54 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056420
- Sponsor's protocol ID
- 030126
- Other IDs
- 03-N-0126
- Status last verified
- 22 Jan 2009
- First submitted
- 12 Mar 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Biswal B, Ulmer JL, Krippendorf RL, Harsch HH, Daniels DL, Hyde JS, Haughton VM. Abnormal cerebral activation associated with a motor task in Tourette syndrome. AJNR Am J Neuroradiol. 1998 Sep;19(8):1509-12.
PubMed 9763386Braun AR, Stoetter B, Randolph C, Hsiao JK, Vladar K, Gernert J, Carson RE, Herscovitch P, Chase TN. The functional neuroanatomy of Tourette's syndrome: an FDG-PET study. I. Regional changes in cerebral glucose metabolism differentiating patients and controls. Neuropsychopharmacology. 1993 Dec;9(4):277-91. doi: 10.1038/npp.1993.64.
PubMed 8305128Brown P, Marsden CD. What do the basal ganglia do? Lancet. 1998 Jun 13;351(9118):1801-4. doi: 10.1016/s0140-6736(97)11225-9.
PubMed 9635969
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
- Spatiotemporal Dynamics of Cortical Connectivity Involved in Tics and Voluntary Movements in Patients With Tourette's Syndrome and Chronic Motor Tic Disorder: An EEG Study
- ClinicalTrials.gov ID
- NCT00056420
- Acronym / sponsor ID
- 030126
- Conditions
- Tourette Syndrome, Tic Disorders
- Keywords
- Tourette's Syndrome, Tic Disorder, (EEG) Electroencephalography, Event-Related Desynchronization/Synchronization, Coherence, Tourette's, Tourette Syndrome, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 10 Mar 2003
- Study completion
- 22 Jan 2009
- First posted
- 13 Mar 2003 (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 use electroencephalography (EEG) and electromyography (EMG) to examine how the brain generates tics and controls voluntary movement in patients with Tourette's syndrome and chronic motor tic disorder. EEG records the electrical activity of the brain. For this test, a cap with built-in electrodes is placed on the subject's head, and the electrodes are connected to a monitor that records the brain activity. EMG records muscle activity using electrodes placed on the skin over muscles on the fingers or above the outer corner of the eyes.
Healthy normal volunteers and patients with Tourette's syndrome and chronic motor tic disorder between 21 and 65 years of age may be eligible for this 2- to 3-hour study. Each candidate will be screened with a medical history, physical and neurological examinations, and a questionnaire that screens for psychiatric disorders.
During EEG and EMG recordings, participants undergo the following tasks while seated comfortably in a sound-shielded room:
Patients
- Finger task: Patients raise their index finger once every 10 seconds for about 25 minutes.
- Tic evaluation and mimicking: Patients allow their tics to occur as they do naturally. After each tic, they report whether the tic was voluntary and whether it was preceded by a sensation of urge. They then mimic tics that they normally have, at a rate of about once every 10 seconds.
- Tic suppression task: Patients suppress tics they normally have for several minutes. They then allow the tics to occur naturally, without attempting to suppress them.
Normal Volunteers
- Finger task: Volunteers raise their index finger once every 10 seconds for about 25 minutes.
- Open eye task: Volunteers keep their eyes open for a minute or so, and then resume blinking as often as feels comfortable. The process is repeated several times.
Detailed description
This study examines the spatiotemporal dynamics of cortical functional interconnectivity involved tics and voluntary movement in patients with Tourette's syndrome or chronic motor tic disorder. By employing a combination of EEG methods that utilize analyses in the domains of both frequency (e.g., event-related desynchronization/synchronization (ERD/ERS), event-related partial coherence, phase coherence) and time (e.g., event-related partial correlation), we intend to determine
- Whether the cortical neurocircuitry involved in the performance of a simple, voluntary motor task differs in patients with tic disorders from that of healthy volunteers;
- Whether the network involved in the generation of unwanted tics differs from that of normal voluntary movement (i.e., mimicked tics); and
- What role, if any, premonitory urge and/or tic suppression plays in the modulation of this neurocircuitry.
Study design
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Healthy volunteers are between the ages of 21 and 65 years.
- Patients will have clinically documented Tourette's syndrome or chronic motor tic disorder as defined by DSM-IV-TR and evaluation of tic severity using the Yale Tic Scale. This criterion will be established by preliminary screening in the NINDS Movement Disorders Outpatient Clinic. Regarding co-morbid disorders such as ADHD and OCD, we will accept a mild degree of ADHD and mild to moderate degree of OCD. These disorders will be established by a psychiatrist using below listed scales and criteria.
- Structure Clinical Interview for (DSMIV SCID) will be administered to all subjects to ensure that strict DSM-IV criteria for Tourette Syndrome have been met and to assess for possible comorbid psychiatric disorders.
- Given the high rate of comorbidity of Obsessive Compulsive Disorder (OCD) and Attention Deficit/Hyperactivity Disorder (ADHD) in Tourette's syndrome, it may not be possible to exclude persons with these disorders. Hence, only those with no more than mild to moderate severity of symptoms will be accepted into the study. This will be ascertained using the following instruments and their respective cut-off scores:
- Y-BOCS (Goodman et al, 1989) a 10 item scale with a range of 0 - 4 and maximum possible score of 40 (0-7: subclinical; 8 - 15: mild; 16 -23: moderate; 24 - 31 severe; 32 - 40: extreme). Inclusion criteria: 23 or below.
Key exclusion criteria (5 listed)
- Subjects younger than 21 or older than 65 years, as EEG studies have shown findings to vary with neurodevelopment and age.
- Subjects with 1) major depression, 2) bipolar disorder, or 3) psychotic disorder. Such coexisting neuropsychiatric disorders may lead to unnecessary confounds of the data.
- Subjects taking benzodiazepines, anti-depressant or neuroleptic medications (such medications are known to affect EEG and may thus confound data)
- Subjects with major acute or chronic illness (experimental setting may be unnecessarily uncomfortable or unpleasant)
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 9763386Biswal B, Ulmer JL, Krippendorf RL, Harsch HH, Daniels DL, Hyde JS, Haughton VM. Abnormal cerebral activation associated with a motor task in Tourette syndrome. AJNR Am J Neuroradiol. 1998 Sep;19(8):1509-12.
- Background: PubMed 8305128Braun AR, Stoetter B, Randolph C, Hsiao JK, Vladar K, Gernert J, Carson RE, Herscovitch P, Chase TN. The functional neuroanatomy of Tourette's syndrome: an FDG-PET study. I. Regional changes in cerebral glucose metabolism differentiating patients and controls. Neuropsychopharmacology. 1993 Dec;9(4):277-91. doi: 10.1038/npp.1993.64.
- Background: PubMed 9635969Brown P, Marsden CD. What do the basal ganglia do? Lancet. 1998 Jun 13;351(9118):1801-4. doi: 10.1016/s0140-6736(97)11225-9.
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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 16 inclusion and 5 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 NCT00056420, 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; AzTrials last refreshed its copy on 30 Oct 2026.