Brain Activity Associated With Tics in Patients With Tourette Syndrome
|ClinicalTrials.gov Identifier: NCT00141869|
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : July 2, 2017
|First Submitted Date||August 31, 2005|
|First Posted Date||September 1, 2005|
|Last Update Posted Date||July 2, 2017|
|Study Start Date||August 30, 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00141869 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Brain Activity Associated With Tics in Patients With Tourette Syndrome|
|Official Title||MEG Study of Altered Sensory Processing in Tourette Syndrome: An Exploration of Sensory Tics|
This study will examine brain activity associated with the involuntary urges or uncontrolled movements, called "tics," experienced by people who have Tourette syndrome (TS). Before people with TS actually develop a tic, whether it is a movement or a vocal tic (like a cough or bark), they feel the urge to tic. This study will look at brain activity during the time of this urge and how brain activity may differ in people with TS and without TS.
Healthy normal volunteers and patients with TS between 14 and 65 years of age may be eligible for this study. Patients must have sensory tics in the facial region and must experience at least a moderate premonitory urge. Candidates are screened with a medical history, brief physical examination, and a questionnaire.
Participants undergo the following procedures:
Patients in the study are contacted for follow-up after the study. Follow-up will be conducted by phone or email, according to the patients' convenience, and will consist of reaffirming that there were no adverse events.
This study will examine the spatiotemporal dynamics of sensory tics in patients with Tourette syndrome (TS). We will also investigate the possible existence of a sensory gating problem. By investigating somatosensory evoked responses from stimulation of the trigeminal nerve (tSERs) on affected versus unaffected sides of the face, we hope to identify differences in the SER waveforms that suggest sensory abnormalities. We will use a series of short trains of stimulations on the affected side to examine habituation, subsequently performing a time-
frequency analysis to seek indicators of decreased sensory gating. This study will examine, specifically:
Whether the cortical neurocircuitry involved in the elicitation of tSERs differs in patients with tic disorders from controls.
If SERs differ in a sensory tic facial region of patients, compared to the same spot on an unaffected side of the face.
Whether in controls and patients with sensory tics on both sides of their body, tSERs on both sides of the face are symmetrical.
If there is a lack of habituation in tic patients to tSERs in a short-train click paradigm, compared to controls.
The location for sources of abnormalities in either paradigm.
Twenty patients and 10 control subjects will be studied. Subjects can be of any race, gender, handedness, or age between 14 and 65 years.
This study will compare tSERs in normal volunteers to those in TS patients. Patients with bilateral sensory tics will be contrasted with those who have unilateral sensory tics, comparing power of the response at latencies on affected versus unaffected sides. Subjects will be seated in the MEG and instructed to "feel the delivered sensation, and try not to tic for seventy seconds, without counting". The trigeminal nerve will be electrically stimulated at 0.25 Hz for 30 seconds, which will be followed by head localization and subsequent rest for tic release. To evaluate sensory gating, the design is similar except the trigeminal stimulation will occur in short trains. Patients will be surveyed to determine if the instructions intensified sensory tics.
We will compare the power of averaged tSERs at latencies, comparing face sides in patients and comparing patients' active face side with controls' dominant face side. The power of frequency components at latencies will be considered. We will locate the sources of differential tSER activity.
|Study Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
|Publications *||Bliss J. Sensory experiences of Gilles de la Tourette syndrome. Arch Gen Psychiatry. 1980 Dec;37(12):1343-7.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Enrollment||Same as current|
|Study Completion Date||September 6, 2007|
|Primary Completion Date||Not Provided|
Subjects will be normal volunteers with no history of neurological disorders; they will be screened in the NINDS Movement Disorders Outpatient Clinic, and will have a neurological and physical examination.
Subjects will be male or female, in age ranges 14 to 65 years old.
INCLUSION CRITERIA FOR PATIENTS:
Patients ages 14 to 65 with a clinical diagnosis of tourette syndrome or chronic motor tic disorder as defined by DSM-IV-TR and evaluation of tic severity using the Yale Tic Scale (YGTSS). This criterion will be established by preliminary screening in the NINDS Movement Disorders Outpatient Clinic. Structure Clinical Interview for (DSMIV SCID) will be administered to all subjects to ensure that strict DSM-IV criteria for Tourette syndrome have been met and to assess for possible comorbid psychiatric disorders.
Patients with at least moderate premonitory urge, as evaluated with the PUTS.
Patients with sensory tics, either bilaterally or unilaterally, in the facial region.
EXCLUSION CRITERIA FOR PATIENTS AND NORMAL VOLUNTEERS:
Cardiac pacemaker / cardiac or neural defibrillators.
Metal fragments in the eyes.
Metal plates, pins, or bolts in the head.
Any magnetic implantation / implantations made from iron (ferrous products).
Problems using response devices.
Subjects younger than 14 or older than 65 years.
Subjects with 1 ) major depression, 2) bipolar disorder, or 3) psychotic disorder.
Subjects taking benzodiazepines, anti-depressant or neuroleptic medications.
Subjects with major acute or chronic illness, or subjects for whom sitting in a still position for an extended period of time would trigger or exacerbate a preexisting condition or cause any undue harm or discomfort.
Pregnant women (steroidal hormones have been shown to influence EEG (Rupprecht et al., 2001).
Patients with severe head tics or subjects who are unable to hold their head still in a scanner for at least 70 seconds.
|Ages||14 Years to 65 Years (Child, Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||050230
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Institute of Neurological Disorders and Stroke (NINDS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 6, 2007|