Tourette's SyndromeNCT00026000
Brain Activation in Vocal and Motor Tics
An observational study of Tourette's Syndrome and Chronic Motor Tic Disorder, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will investigate the brain areas that are activated by vocal and motor tics in patients with Tourette's syndrome and other tic disorders. Tics are involuntary repetitive movements similar to voluntary movements. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tourette's Syndrome, Chronic Motor Tic Disorder, Chronic Motor Vocal Disorder
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Jan 2005
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients will have a clinically documented tic disorder as defined by DSM-IV-TR and evaluation of tics severity using Yale Tic Sale. This criterion will be established by the preliminary screening in the NINDS Movement Disorders Outpatient Clinic.
- Patients will be in age range 14 to 65.
- Patients may be male or female.
- Patients will be asked to stop any medications that can influence central nervous system for at least 24 hours prior to exam also they will be asked to abstain from alcohol for 24 hours before the study.
- 10 normal controls will be included; controls will be screened in the NINDS Movement Disorders Outpatient Clinic, and will have neurological and physical examination.
- Controls with chronic illnesses, taking any medication that affects the CNS will be excluded.
- Controls will be asked to abstain from alcohol for 24 hours before the study.
- All subjects participating in MR studies should have a valid Clinical Center Medical Record Number.
Who cannot join
- Patients younger than 14 years old will be excluded from the study.
- Patients with MRI findings consistent with brain tumors, strokes, trauma or AVMs will be excluded.
- Patients with progressive neurological disorders other than a tic disorder will be excluded.
- Patients with a history of significant medical disorders, or requiring chronic treatment with other drugs, which cannot be stopped, will be excluded.
- Patients with cancer will be excluded.
- Pregnant women will be excluded.
- Patients not capable of giving informed consent will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Brain Activation in Motor and Vocal Tics in Patients With Tourette's Syndrome or Chronic Motor or Vocal Tic Disorder Using Blood Oxygenation Level Dependent Functional MRI
This study will investigate the brain areas that are activated by vocal and motor tics in patients with Tourette's syndrome and other tic disorders. Tics are involuntary repetitive movements similar to voluntary movements. They may be simple, involving only a few muscles or simple sounds, or complex, involving several groups of muscles in orchestrated bouts. This study will involve only simple motor tics, such as eye blinking, nose wrinkling, facial grimacing and abdominal tensing, and simple vocal tics, such as throat clearing, sniffing and snorting.
Healthy normal volunteers and patients between 14 and 65 years of age with simple motor or vocal tics may be eligible for this study.
Read more
Participants will have a brief medical history and physical examination and magnetic resonance imaging (MRI) of the brain. MRI uses a magnetic field and radio waves to produce images. For the procedure, the subject lies on a table that is moved into a cylindrical chamber containing a strong magnet. Earplugs are worn to muffle the loud thumping sounds made by electrical switching of the radio frequency circuits and protect against temporary hearing impairment.
During the scan, normal volunteers will be asked to make simple movements or sounds designed to imitate tics, such as raising eyebrows, blinking or coughing. Patients with tic disorders will have two parts to the scanning session. First they will relax and allow tics to occur spontaneously, then they will be asked to imitate a specific tic when there is no urge to tic.
Patients and healthy subjects will have electromyography (EMG) to record the timing of the voluntary movements and tics. For this procedure, several pairs of small, saucer-like electrodes are attached to the skin with a gel or paste. Electric signals from the electrodes are amplified and recorded on a computer. A microphone may be placed near patients to record any vocal tics. A video camera may also be used to record the tics.
Read the detailed description
The purpose of this study is to determine the areas of the brain responsible for motor tics in patients with tic disorders including Tourette's Syndrome and Chronic Motor or Vocal Tic Disorder. Previous studies have been done looking at brain activity during tics using electroencephalography (EEG) and positron emission tomography (PET). 16 adult patients with DSM-IV-TR (American Psychiatric Association 2000) diagnosis of a tic disorder and frequent tics will be studied. We will utilize blood oxygenation level dependent functional magnetic resonance imaging (BOLD fMRI) on patients with tics while they are experiencing spontaneous tics and while they are voluntarily imitating those tics. The differential activation between the tics and the voluntary movements may shed light on the regions of the brain responsible for generation of tics.
- Keywords
- Voluntary Movement, Basal Ganglia, Frontal Lobe, Motor Cortex, Motor Tic Disorder, Tourette's Syndrome, Vocal Tic Disorder, Tic, Healthy Volunteer, HV, Normal Control
- Medical subject headings
- Tourette Syndrome, Tic Disorders, Tics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2001 (estimated)
- Study startNov 2001
- Study completionJan 2005
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's 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
- 30 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
- NCT00026000
- Sponsor's protocol ID
- 020027
- Other IDs
- 02-N-0027
- Status last verified
- Jan 2005
- First submitted
- 2 Nov 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Karp BI, Porter S, Toro C, Hallett M. Simple motor tics may be preceded by a premotor potential. J Neurol Neurosurg Psychiatry. 1996 Jul;61(1):103-6. doi: 10.1136/jnnp.61.1.103.
PubMed 8676135Makeig S, Jung TP, Bell AJ, Ghahremani D, Sejnowski TJ. Blind separation of auditory event-related brain responses into independent components. Proc Natl Acad Sci U S A. 1997 Sep 30;94(20):10979-84. doi: 10.1073/pnas.94.20.10979.
PubMed 9380745Obeso JA, Rothwell JC, Marsden CD. Simple tics in Gilles de la Tourette's syndrome are not prefaced by a normal premovement EEG potential. J Neurol Neurosurg Psychiatry. 1981 Aug;44(8):735-8. doi: 10.1136/jnnp.44.8.735.
PubMed 6946193
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Activation in Motor and Vocal Tics in Patients With Tourette's Syndrome or Chronic Motor or Vocal Tic Disorder Using Blood Oxygenation Level Dependent Functional MRI
- ClinicalTrials.gov ID
- NCT00026000
- Acronym / sponsor ID
- 020027
- Keywords
- Voluntary Movement, Basal Ganglia, Frontal Lobe, Motor Cortex, Motor Tic Disorder, Tourette's Syndrome, Vocal Tic Disorder, Tic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Nov 2001
- Study completion
- Jan 2005
- First posted
- 5 Nov 2001 (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 brain areas that are activated by vocal and motor tics in patients with Tourette's syndrome and other tic disorders. Tics are involuntary repetitive movements similar to voluntary movements. They may be simple, involving only a few muscles or simple sounds, or complex, involving several groups of muscles in orchestrated bouts. This study will involve only simple motor tics, such as eye blinking, nose wrinkling, facial grimacing and abdominal tensing, and simple vocal tics, such as throat clearing, sniffing and snorting.
Healthy normal volunteers and patients between 14 and 65 years of age with simple motor or vocal tics may be eligible for this study.
Participants will have a brief medical history and physical examination and magnetic resonance imaging (MRI) of the brain. MRI uses a magnetic field and radio waves to produce images. For the procedure, the subject lies on a table that is moved into a cylindrical chamber containing a strong magnet. Earplugs are worn to muffle the loud thumping sounds made by electrical switching of the radio frequency circuits and protect against temporary hearing impairment.
During the scan, normal volunteers will be asked to make simple movements or sounds designed to imitate tics, such as raising eyebrows, blinking or coughing. Patients with tic disorders will have two parts to the scanning session. First they will relax and allow tics to occur spontaneously, then they will be asked to imitate a specific tic when there is no urge to tic.
Patients and healthy subjects will have electromyography (EMG) to record the timing of the voluntary movements and tics. For this procedure, several pairs of small, saucer-like electrodes are attached to the skin with a gel or paste. Electric signals from the electrodes are amplified and recorded on a computer. A microphone may be placed near patients to record any vocal tics. A video camera may also be used to record the tics.
Detailed description
The purpose of this study is to determine the areas of the brain responsible for motor tics in patients with tic disorders including Tourette's Syndrome and Chronic Motor or Vocal Tic Disorder. Previous studies have been done looking at brain activity during tics using electroencephalography (EEG) and positron emission tomography (PET). 16 adult patients with DSM-IV-TR (American Psychiatric Association 2000) diagnosis of a tic disorder and frequent tics will be studied. We will utilize blood oxygenation level dependent functional magnetic resonance imaging (BOLD fMRI) on patients with tics while they are experiencing spontaneous tics and while they are voluntarily imitating those tics. The differential activation between the tics and the voluntary movements may shed light on the regions of the brain responsible for generation of tics.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients will have a clinically documented tic disorder as defined by DSM-IV-TR and evaluation of tics severity using Yale Tic Sale. This criterion will be established by the preliminary screening in the NINDS Movement Disorders Outpatient Clinic.
- Patients will be in age range 14 to 65.
- Patients may be male or female.
- Patients will be asked to stop any medications that can influence central nervous system for at least 24 hours prior to exam also they will be asked to abstain from alcohol for 24 hours before the study.
- 10 normal controls will be included; controls will be screened in the NINDS Movement Disorders Outpatient Clinic, and will have neurological and physical examination.
Key exclusion criteria (7 listed)
- Patients younger than 14 years old will be excluded from the study.
- Patients with MRI findings consistent with brain tumors, strokes, trauma or AVMs will be excluded.
- Patients with progressive neurological disorders other than a tic disorder will be excluded.
- Patients with a history of significant medical disorders, or requiring chronic treatment with other drugs, which cannot be stopped, will be excluded.
- Patients with cancer will be excluded.
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 4 Mar 2008.
- Background: PubMed 8676135Karp BI, Porter S, Toro C, Hallett M. Simple motor tics may be preceded by a premotor potential. J Neurol Neurosurg Psychiatry. 1996 Jul;61(1):103-6. doi: 10.1136/jnnp.61.1.103.
- Background: PubMed 9380745Makeig S, Jung TP, Bell AJ, Ghahremani D, Sejnowski TJ. Blind separation of auditory event-related brain responses into independent components. Proc Natl Acad Sci U S A. 1997 Sep 30;94(20):10979-84. doi: 10.1073/pnas.94.20.10979.
- Background: PubMed 6946193Obeso JA, Rothwell JC, Marsden CD. Simple tics in Gilles de la Tourette's syndrome are not prefaced by a normal premovement EEG potential. J Neurol Neurosurg Psychiatry. 1981 Aug;44(8):735-8. doi: 10.1136/jnnp.44.8.735.
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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's Syndrome and Chronic Motor Tic Disorder, 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 8 inclusion and 7 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 4 Mar 2008. 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 NCT00026000, 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 4 Mar 2008.