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Magnetic Resonance Spectroscopy to Evaluate Tourette s Syndrome

Primary Purpose

Tourette Syndrome

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Tourette Syndrome focused on measuring Tourette's Syndrome, GABA, NAA, Choline, Creatine, Tourette Syndrome, Healthy Volunteer, HV, Normal Control

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
December 14, 2019
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00030953
Brief Title
Magnetic Resonance Spectroscopy to Evaluate Tourette s Syndrome
Official Title
Evaluation of Tourette's Syndrome With Multimetabolite H-Magnetic Resonance Spectroscopy at 3T
Study Type
Observational

2. Study Status

Record Verification Date
February 3, 2015
Overall Recruitment Status
Completed
Study Start Date
February 11, 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 3, 2015 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome
Keywords
Tourette's Syndrome, GABA, NAA, Choline, Creatine, Tourette Syndrome, Healthy Volunteer, HV, Normal Control

7. Study Design

Enrollment
100 (Actual)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Hallett, M.D.
Organizational Affiliation
National Institute of Neurological Disorders and Stroke (NINDS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9763386
Citation
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.
Results Reference
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PubMed Identifier
10923985
Citation
Bolam 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.
Results Reference
background
PubMed Identifier
8305128
Citation
Braun 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.
Results Reference
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Magnetic Resonance Spectroscopy to Evaluate Tourette s Syndrome

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