Tourette SyndromeNCT00141869
Brain Activity Associated With Tics in Patients With Tourette 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 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. Read more about this study
- Who is it for?
- Ages 14 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourette Syndrome
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2005to 6 Sep 2007
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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).
- Hearing problems.
- Problems using response devices.
Show all 12Show fewer
- 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.
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: 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.
Read more
Participants undergo the following procedures:
- Magnetoencephalography (MEG): This test records magnetic field changes produced by brain activity. During the test, the subjects are seated in the MEG recording room and a cone containing magnetic field detectors is lowered onto their head. Electrodes (small metal disks) are placed on both sides of the face near the jaw. The recording may be made while the subject receives small currents from the electrodes on the jaw. Subjects may be asked a few questions about what they felt during the procedure.
- Magnetic resonance imaging (MRI): This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. During the procedure, the subject lies on a table that can slide in and out of the scanner-a metal cylinder. Subjects may be asked to lie still for up to 30 minutes at a time. They can communicate with the staff at any time during the scan.
- Somatosensory evoked responses: This test examines how sensory information travels form the nerves to the spinal cord and brain in the nervous system. An electrode placed on the arm, leg, or face delivers a small electrical stimulus that may tingle and cause a twitch of a hand, foot, or face muscle. Additional electrodes may sometimes be placed on the scalp, neck, and over the collarbone to record how the impulse from the stimulus travels over nerve pathways.
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.
Read the detailed description
OBJECTIVES:
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.
STUDY POPULATION:
Twenty patients and 10 control subjects will be studied. Subjects can be of any race, gender, handedness, or age between 14 and 65 years.
DESIGN:
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.
OUTCOME MEASURES:
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.
- Conditions
- Tourette Syndrome
- Keywords
- Sensory Processing, Magnetoencephalogram, Tourete Syndrome, Trigeminal Nerve, Tics, TS, Healthy Volunteer, HV
- Medical subject headings
- Tourette Syndrome, Tics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study start30 Aug 2005
- Study completion6 Sep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 30 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141869
- Sponsor's protocol ID
- 050230
- Other IDs
- 05-N-0230
- Status last verified
- 6 Sep 2007
- First submitted
- 31 Aug 2005
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Bliss J. Sensory experiences of Gilles de la Tourette syndrome. Arch Gen Psychiatry. 1980 Dec;37(12):1343-7. doi: 10.1001/archpsyc.1980.01780250029002.
PubMed 6934713
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEG Study of Altered Sensory Processing in Tourette Syndrome: An Exploration of Sensory Tics
- ClinicalTrials.gov ID
- NCT00141869
- Acronym / sponsor ID
- 050230
- Conditions
- Tourette Syndrome
- Keywords
- Sensory Processing, Magnetoencephalogram, Tourete Syndrome, Trigeminal Nerve, Tics, TS, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 30 Aug 2005
- Study completion
- 6 Sep 2007
- First posted
- 1 Sep 2005 (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 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:
- Magnetoencephalography (MEG): This test records magnetic field changes produced by brain activity. During the test, the subjects are seated in the MEG recording room and a cone containing magnetic field detectors is lowered onto their head. Electrodes (small metal disks) are placed on both sides of the face near the jaw. The recording may be made while the subject receives small currents from the electrodes on the jaw. Subjects may be asked a few questions about what they felt during the procedure.
- Magnetic resonance imaging (MRI): This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. During the procedure, the subject lies on a table that can slide in and out of the scanner-a metal cylinder. Subjects may be asked to lie still for up to 30 minutes at a time. They can communicate with the staff at any time during the scan.
- Somatosensory evoked responses: This test examines how sensory information travels form the nerves to the spinal cord and brain in the nervous system. An electrode placed on the arm, leg, or face delivers a small electrical stimulus that may tingle and cause a twitch of a hand, foot, or face muscle. Additional electrodes may sometimes be placed on the scalp, neck, and over the collarbone to record how the impulse from the stimulus travels over nerve pathways.
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.
Detailed description
OBJECTIVES:
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.
STUDY POPULATION:
Twenty patients and 10 control subjects will be studied. Subjects can be of any race, gender, handedness, or age between 14 and 65 years.
DESIGN:
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.
OUTCOME MEASURES:
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
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (12 listed)
- 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).
- Hearing problems.
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 2 Jul 2017.
- Background: PubMed 6934713Bliss J. Sensory experiences of Gilles de la Tourette syndrome. Arch Gen Psychiatry. 1980 Dec;37(12):1343-7. doi: 10.1001/archpsyc.1980.01780250029002.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 5 inclusion and 12 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 2 Jul 2017. 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 NCT00141869, which also lists 1 linked publication.
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 2 Jul 2017.