Tourette SyndromeNCT00030953
Magnetic Resonance Spectroscopy to Evaluate Tourette s Syndrome
An observational study of Tourette Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will use magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) of the brain to try to gain a better understanding of the disease process in Tourette s syndrome, a neuropsychiatric disorder characterized by motor and vocal tics. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Tourette Syndrome
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2002to 3 Feb 2015
- 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients will have clinically documented TS as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV and an evaluation of tics severity using the Yale Tic Scale.
- Fourty-four patients, ranging from 14-65 in age, will be recruited. Patients and normal volunteers may be male or female; however, female subjects of child bearing potential will have a pregnancy test and an interview prior to the study to ensure that pregnant subjects will not participate in the study. Patients will be asked to stop any medication that can influence their central nervous system for one week prior to exam. They will be asked to abstain from alcohol for one week before the study.
- Sixty-two normal controls will be included; controls will be screened in the NINDS Movement Disorders Outpatient Clinic. After screening and consenting, controls will have neurological and physical examinations. Controls with chronic illnesses, taking any medication that affects the CNS will be excluded. Female subjects of child bearing potential will have a pregnancy test and an interview prior to the study to ensure that pregnant subjects will not participate in the study. They will be asked to abstain from alcohol for one week before the study. More controls will be needed in order to ensure that the sequence is working prior to the acquisition of data, since the sequence has only been used in the 1.5T MRI scanner and we will be using the 3T.
Who cannot join
- Subjects younger than 14 years old.
- Patients with MRI findings consistent with brain tumors, strokes, trauma or arteriovenous malformations (AVMs).
- Patients with progressive neurological disorders other than Tourette's syndrome.
- Patients with a history of significant medical disorders, or who require chronic treatment with other drugs which cannot be stopped.
- Subjects with implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except mouth, intracardiac lines, history of shrapnel injury or any other condition/device that may be contraindicated or prevent the acquisition of the MRI.
- Patients with cancer.
- 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: Evaluation of Tourette's Syndrome With Multimetabolite H-Magnetic Resonance Spectroscopy at 3T
This study will use magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) of the brain to try to gain a better understanding of the disease process in Tourette s syndrome, a neuropsychiatric disorder characterized by motor and vocal tics. Tourette s syndrome is also associated with behavioral and emotional disturbances, including symptoms of attention deficit hyperactivity disorder (ADHD) and obsessive-compulsive disorder (OCD). MRI and MRS show chemical substances in the brain. Findings in normal volunteers will be compared with those of patients.
Healthy volunteers and patients with Tourette s syndrome 14 years of age and older may be eligible for this study. Volunteers will be screened with a medical history and physical and neurological examinations. Patients will be screened through NINDS protocol 93-N-0202.
Participants will undergo MRI and MRS. MRI uses a strong magnetic field and radio waves to visualize brain anatomy and chemistry. For this study, the subject lies on a stretcher, which is moved into a strong magnetic field (the MRI scanner). Earplugs are worn to muffle loud thumping noises caused by the electrical switching of the radio frequency circuits. During the study, the subject lies still during each scan, for 1 to 8 minutes at a time. Total scanning time varies from 20 minutes to 2 hours, with most examinations lasting between 45 and 90 minutes. The subject can speak through an intercom with the staff member performing the study at all times during the procedure. Up to 5 studies may be performed.
Read the detailed description
OBJECTIVE
The purpose of this study is to obtain a better understanding of the pathophysiology of Tourette's Syndrome (TS) with nuclear magnetic spectroscopic imaging. The basal ganglia have been implicated in the origin of tics, and we plan to use spectroscopy to determine whether there is any neuronal degeneration or a decrease in aminobutyric acid (GABA) within the basal ganglia, thalamus, or frontal cortex of patients with TS when compared to normal individuals.
STUDY POPULATION
This research will be conducted using patients with TS and normal volunteers.
DESIGN
Patients and normal volunteers will be scanned with 3 Tesla General Electric (GE) magnetic resonance imager using magnetic resonance spectroscopy (MRS) to measure N-acetylaspartate, choline, creatine, lactate and GABA.
OUTCOME MEASURES
Concentrations of metabolites will be compared between two groups.
- Conditions
- Tourette Syndrome
- Keywords
- Tourette's Syndrome, GABA, NAA, Choline, Creatine, Tourette Syndrome, Healthy Volunteer, HV, Normal Control
- Medical subject headings
- Tourette Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2002 (estimated)
- Study start11 Feb 2002
- Study completion3 Feb 2015
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
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030953
- Sponsor's protocol ID
- 020128
- Other IDs
- 02-N-0128
- Status last verified
- 3 Feb 2015
- First submitted
- 14 Feb 2002
- Last updated
- 17 Dec 2019
- 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 9763386Bolam JP, Hanley JJ, Booth PA, Bevan MD. Synaptic organisation of the basal ganglia. J Anat. 2000 May;196 ( Pt 4)(Pt 4):527-42. doi: 10.1046/j.1469-7580.2000.19640527.x.
PubMed 10923985Braun 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 8305128
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tourette's Syndrome With Multimetabolite H-Magnetic Resonance Spectroscopy at 3T
- ClinicalTrials.gov ID
- NCT00030953
- Acronym / sponsor ID
- 020128
- Conditions
- Tourette Syndrome
- Keywords
- Tourette's Syndrome, GABA, NAA, Choline, Creatine, Tourette Syndrome, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 11 Feb 2002
- Study completion
- 3 Feb 2015
- First posted
- 15 Feb 2002 (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 magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) of the brain to try to gain a better understanding of the disease process in Tourette s syndrome, a neuropsychiatric disorder characterized by motor and vocal tics. Tourette s syndrome is also associated with behavioral and emotional disturbances, including symptoms of attention deficit hyperactivity disorder (ADHD) and obsessive-compulsive disorder (OCD). MRI and MRS show chemical substances in the brain. Findings in normal volunteers will be compared with those of patients.
Healthy volunteers and patients with Tourette s syndrome 14 years of age and older may be eligible for this study. Volunteers will be screened with a medical history and physical and neurological examinations. Patients will be screened through NINDS protocol 93-N-0202.
Participants will undergo MRI and MRS. MRI uses a strong magnetic field and radio waves to visualize brain anatomy and chemistry. For this study, the subject lies on a stretcher, which is moved into a strong magnetic field (the MRI scanner). Earplugs are worn to muffle loud thumping noises caused by the electrical switching of the radio frequency circuits. During the study, the subject lies still during each scan, for 1 to 8 minutes at a time. Total scanning time varies from 20 minutes to 2 hours, with most examinations lasting between 45 and 90 minutes. The subject can speak through an intercom with the staff member performing the study at all times during the procedure. Up to 5 studies may be performed.
Detailed description
OBJECTIVE
The purpose of this study is to obtain a better understanding of the pathophysiology of Tourette's Syndrome (TS) with nuclear magnetic spectroscopic imaging. The basal ganglia have been implicated in the origin of tics, and we plan to use spectroscopy to determine whether there is any neuronal degeneration or a decrease in aminobutyric acid (GABA) within the basal ganglia, thalamus, or frontal cortex of patients with TS when compared to normal individuals.
STUDY POPULATION
This research will be conducted using patients with TS and normal volunteers.
DESIGN
Patients and normal volunteers will be scanned with 3 Tesla General Electric (GE) magnetic resonance imager using magnetic resonance spectroscopy (MRS) to measure N-acetylaspartate, choline, creatine, lactate and GABA.
OUTCOME MEASURES
Concentrations of metabolites will be compared between two groups.
Study design
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients will have clinically documented TS as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV and an evaluation of tics severity using the Yale Tic Scale.
- Fourty-four patients, ranging from 14-65 in age, will be recruited. Patients and normal volunteers may be male or female; however, female subjects of child bearing potential will have a pregnancy test and an interview prior to the study to ensure that pregnant subjects will not participate in the study. Patients will be asked to stop any medication that can influence their central nervous system for one week prior to exam. They will be asked to abstain from alcohol for one week before the study.
- Sixty-two normal controls will be included; controls will be screened in the NINDS Movement Disorders Outpatient Clinic. After screening and consenting, controls will have neurological and physical examinations. Controls with chronic illnesses, taking any medication that affects the CNS will be excluded. Female subjects of child bearing potential will have a pregnancy test and an interview prior to the study to ensure that pregnant subjects will not participate in the study. They will be asked to abstain from alcohol for one week before the study. More controls will be needed in order to ensure that the sequence is working prior to the acquisition of data, since the sequence has only been used in the 1.5T MRI scanner and we will be using the 3T.
Key exclusion criteria (7 listed)
- Subjects younger than 14 years old.
- Patients with MRI findings consistent with brain tumors, strokes, trauma or arteriovenous malformations (AVMs).
- Patients with progressive neurological disorders other than Tourette's syndrome.
- Patients with a history of significant medical disorders, or who require chronic treatment with other drugs which cannot be stopped.
- Subjects with implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except mouth, intracardiac lines, history of shrapnel injury or any other condition/device that may be contraindicated or prevent the acquisition of the MRI.
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 17 Dec 2019.
- 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 10923985Bolam JP, Hanley JJ, Booth PA, Bevan MD. Synaptic organisation of the basal ganglia. J Anat. 2000 May;196 ( Pt 4)(Pt 4):527-42. doi: 10.1046/j.1469-7580.2000.19640527.x.
- 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.
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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 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 3 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 17 Dec 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00030953, 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 17 Dec 2019.