NIH Clinical Research Studies

Protocol Number: 08-N-0215

Active Accrual, Protocols Recruiting New Patients

Title:
Understanding the Anatomy and Physiology of the Sensory Experience and its Role in Generating Tics in Tourette Syndrome
Number:
08-N-0215
Summary:
This study will investigate the sensation that many people with Tourette syndrome (TS) experience before they have a motor tic. It will also test whether blocking the sensation causes the tic to stop.

People between 18 and 65 years of age with TS who have at least once tic involving an arm may be eligible for this 3-part study. Those enrolled may participate in all parts or in part 1 or part 2. Those who choose to participate in part 3 must first complete part 2. All must stop taking medication for TS and any other medication that may affect the brain for at least 1 week before the study.

Part 1

After numbing the skin or muscles of the arm or leg where a pre-tic sensation is experienced, the response of the nerves will be tested by asking subjects to rate the strength of the sensation after a pinprick and by stimulating the nerves with small electrical shocks. Then, over the course of approximately one hour, subjects will report pre-tic sensations while their motor tics are counted. The onset of each tic will be identified with EMG, a test using electrodes on the skin to indicate the activity of the muscles.

Part 2

Subjects' brain waves are recorded using magnetoencephalography (MEG) while they are experiencing tics andpre-tic sensory experiences. MEG is a test that records magnetic field changes produced by brain activity. Subjects sit in a chair under a dome containing magnetic field detectors. They watch a clock and report the time a sensory experience starts. Tics are recorded with EMG. Later, a standard MRI of the brain (scan using a magnetic field and radio waves) is done to see which parts of the brain produced the activity recorded with MEG.

Part 3

Repetitive transcranial magnetic stimulation (rTMS) is used to try to stop the pre-tic sensations. For TMS, the subject sits in a chair. A wire coil is held on the subject's scalp, and a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates a region of the brain. The goal of this stimulation is to reduce the sensory experience that precedes a tic in one region of the body. During stimulation, the subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm or leg. This study uses a pattern of repeated pulses delivered in short bursts. Following each train of pulses, the effect of the stimulation on sensation will be tested by asking the subject to rate the strength of a pinprick and of a vibration. In addition, the nerves are stimulated with small shocks to evaluate the effect of the TMS on nerve activity. To determine the effect of TMS on the pre-tic sensation, subjects are asked to watch a clock and report when they are having a sensory experience. The effect on motor tics will be evaluated by using EMG to indicate the tics.

Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

Subjects must be 18-65 years of age of any race, gender, or handedness. They must be able to sit for at least 2 hours and remain at the testing site for up to 8 hours. They must be able to follow instructions and participate in reporting sensory experiences. The upper extremity tic to be studied must occur at least once a minute, but no more frequently than once every 5 seconds. Individuals with comorbid attention deficit disorder (ADD or ADHD) or with obsessive-compulsive disorder (OCD) will not be excluded.

EXCLUSION CRITERIA:

1. Inability to stop taking all central-acting medications, including those used to treat tics, for at least one week prior to the study

2. Current use of coumadin, heparin, or lovenox

3. Any additional movement disorder, including tremor, myoclonus, or dystonia

4. A diagnosis of major depression or bipolar disorder

5. Frequent or severe headaches

6. Any history of or current experience of hallucinations

7. Any history of a seizure or epilepsy or a family history of epilespy

8. Any prior brain injury, brain tumor or other lesion, stroke, or surgery

9. A diagnosis of increased intracranial pressure

10. Any history of cardiac or respiratory problems following local anesthesia with the lidocaine or novocaine type of drug (part I only).

11. A history of significant heart disease

12. Any history of hearing problems (part III only)

13. Any of the following: pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments (part II and III only)

14. Any history of work as a welder or metal worker (part II and III only)

15. Current pregnancy

Special Instructions:
Currently Not Provided
Keywords:
Repetitive TMS (rTMS)
Magnetoencephalogram
Transcranial Magnetic Stimulation (TMS)
Tourette Syndrome
Tic Disorder
Recruitment Keyword(s):
Tourete Syndrome
Tic Disorder
Condition(s):
Tic Disorder
Tourette Syndrome
Investigational Drug(s):
None
Investigational Device(s):
Figure 8 Coil and MagStim 200
Intervention(s):
None
Supporting Site:
National Institute of Neurological Disorders and Stroke

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Aoki KR. Review of a proposed mechanism for the antinociceptive action of botulinum toxin type A. Neurotoxicology. 2005 Oct;26(5):785-93. Epub 2005 Jul 5.

Alary F, Sim›es C, JousmŠki V, Forss N, Hari R. Cortical activation associated with passive movements of the human index finger: an MEG study.Neuroimage. 2002 Mar; 15(3):691-6.

Banaschewski T, Woerner W, Rothenberger A. Premonitory sensory phenomena and suppressibility of tics in Tourette syndrome: developmental aspects in children and adolescents. Dev Med Child Neurol. 2003 Oct; 45(10):700-3.

Active Accrual, Protocols Recruiting New Patients

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