NCT00755339

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
8.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2016

Completed
Last Updated

October 25, 2019

Status Verified

October 25, 2016

First QC Date

September 17, 2008

Last Update Submit

October 24, 2019

Conditions

Keywords

Repetitive TMS (rTMS)MagnetoencephalogramTranscranial Magnetic Stimulation (TMS)Tourette SyndromeTic DisorderTourete Syndrome

Outcome Measures

Primary Outcomes (1)

  • Inhibition of the sensory experience frequency and intensity.

Secondary Outcomes (1)

  • The relationship between inhibition of sensory and motor experiences; and detecting and localizing an electromagnetic signal corresponding to the sensory experience.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tourette 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.
  • Healthy volunteers must be 18-65 years of age, of any race, gender, or handedness.

You may not qualify if:

  • Inability to stop taking all central-acting medications, including those used to treat tics, for at least one week prior to the study
  • Current use of coumadin, heparin, or lovenox
  • Any additional movement disorder, including tremor, myoclonus, or dystonia
  • A diagnosis of major depression or bipolar disorder
  • Frequent or severe headaches
  • Any history of or current experience of hallucinations
  • Any history of a seizure or epilepsy or a family history of epilespy
  • Any prior brain injury, brain tumor or other lesion, stroke, or surgery
  • A diagnosis of increased intracranial pressure
  • A history of significant heart disease
  • Any history of hearing problems, or abnormal results on auditory testing (part I or II)
  • 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 I and II only)
  • Any history of work as a welder or metal worker (part I and II)
  • Current pregnancy
  • Tobacco use (cigarette, chewing, or other) in the month prior to the study (part II)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Aoki KR. Review of a proposed mechanism for the antinociceptive action of botulinum toxin type A. Neurotoxicology. 2005 Oct;26(5):785-93. doi: 10.1016/j.neuro.2005.01.017. Epub 2005 Jul 5.

    PMID: 16002144BACKGROUND
  • Alary F, Simoes C, Jousmaki 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. doi: 10.1006/nimg.2001.1010.

    PMID: 11848712BACKGROUND
  • 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. doi: 10.1017/s0012162203001294.

    PMID: 14515942BACKGROUND

MeSH Terms

Conditions

Tic DisordersTourette Syndrome

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurodevelopmental DisordersMental DisordersBasal Ganglia DiseasesBrain DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mark Hallett, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

September 17, 2008

First Posted

September 18, 2008

Study Start

September 15, 2008

Study Completion

October 25, 2016

Last Updated

October 25, 2019

Record last verified: 2016-10-25

Locations