Tourette's SyndromeNCT00368433
Hypersensitivity in Tourette Syndrome
An observational study of Tourette's Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will investigate how the sensitivity to touch and smell in patients with Tourette syndrome (TS) may differ from that of people without TS. TS is a neurological disorder that causes people to have uncontrolled movements called "tics." A tic can also be vocal, like a cough or bark or string of bad words. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tourette's Syndrome
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2006to 24 May 2011
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy Volunteers ages 18 to 65 who have who have given their consent.
- Patients will be ages 18 to 65 and have clinically documented Tourette's syndrome or chronic motor tic disorder as defined by DSM-IV-TR (American Psychiatric Association, 2000) and evaluation of tic severity using the Yale Tic Scale (YGTS). 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 patients 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.
Who cannot join
- Subjects younger than 18 or older than 65 years.
- Subjects with 1) major depression, 2) bipolar disorder, or 3) psychotic disorder.
- Subjects who are unable to abstain from alcohol or any psychiatric medications 24 hours prior to the study.
- Subjects with acute or chronic upper respiratory illness, nasal allergies, or subjects using medications to treat these conditions, including antihistamines, nasal topical steroids, vasoconstrictor nasal sprays, or normal saline sprays.
- Women who are pregnant.
- Individuals with Restless Legs syndrome.
- Individuals with a diagnosis of peripheral neuropathy.
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: Hypersensitivity in Tourette Syndrome: An Evaluation of Perceived Intensity Versus Threshold
This study will investigate how the sensitivity to touch and smell in patients with Tourette syndrome (TS) may differ from that of people without TS. TS is a neurological disorder that causes people to have uncontrolled movements called "tics." A tic can also be vocal, like a cough or bark or string of bad words. The tic is preceded by a "premonitory urge" that may feel like an itch or pressure that builds until the tic occurs. To some patients, the tic feels like a response to an involuntary sensation. In patients with TS, sensory information may be processed differently than it is in people without TS. This study will compare how strong a sensation feels in TS patients and healthy volunteers. It will also look for muscle activity that may be responsible for the feelings in the area of the tic.
Healthy normal volunteers and people with Tourette syndrome, 18 to 65 years of age, may be eligible for this study. Candidates are screened with a medical history and brief physical and neurological examinations. TS patients complete a questionnaire about their tics and are interviewed by a psychiatrist. Women who can become pregnant will have a urine pregnancy test prior to any other procedures. Pregnant women cannot participate.
Read more
All participants undergo sensory testing for touch and smell. They are asked to distinguish between a scented and scentless object and rate how strongly they feel the scent. Later, with their eyes closed, they are asked to tell whether or not they are being touched, and to rate how intensely they felt the touch.
In addition to the sensory testing, TS patients, but not normal volunteers, undergo electromyography (EMG), a test that measures the electrical activity of muscles. For surface EMG, small metal disks called electrodes are filled with a conductive gel and taped to the skin. Wire EMG involves inserting a wire into a muscle using a needle. All patients have surface EMG and those who consent to it will also have wire EMG.
Read the detailed description
OBJECTIVE:
This study will explore sensory phenomena associated with Tourette syndrome (TS). The first part will evaluate threshold levels versus perceived intensity of tactile and olfactory stimuli in areas reported to be hypersensitive in TS patients. The second part will use electromyography (EMG) to seek correlation between muscle activity and the perceived intensity of "urge" in focal areas of premonitory sensations.
STUDY POPULATION:
Twenty-six patients and 22 control subjects will be studied. Subjects can be of any race, gender, handedness, or age from 18 to 65 years.
DESIGN:
To determine olfactory and tactile threshold, n-butanol and Von Frey hairs will be presented in forced-choice modified method of limits paradigms. Perceived intensity will be examined using a generalized labeled magnitude scale (gLMS), whose word values are placed on a ruler for numerical reporting. Randomly arranged series of 7 stimuli for olfaction and touch will be presented in 4 sets, and subjects will report a number on the gLMS that corresponds to the intensity of each sensation. Both threshold and intensity will be measured in the peroneal nerve territory in all subjects, and at one other variable place, which will be matched 1:1 between patients and controls. The variable spot will consist of a patient's sensory tic site. Next, EMG activity will be measured from up to 8 muscles in the area of a sensory tic. Patients will report when a sensory tic is occurring, and will be asked to resist the motor tic for at least 12 seconds from that point. Total EMG activity will be measured in muscles surrounding the sensation at 1, 4, and 7 seconds before and after the tic.
OUTCOME MEASURES:
Outcome measures include the sensory threshold values for olfaction and touch and the reported intensity values. The outcome measures of the EMG study include the power of total EMG activity at time points before and after a tic.
- Conditions
- Tourette's Syndrome
- Keywords
- Sensory Processing, Electromyogram, Tic Disorder, Tourette Syndrome, Tourette's Syndrome, Healthy Volunteer, HV
- Medical subject headings
- Tourette Syndrome, Tic Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2006 (estimated)
- Study start21 Aug 2006
- Study completion24 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tourette's SyndromeStudies of the same condition, open and under way.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368433
- Sponsor's protocol ID
- 060232
- Other IDs
- 06-N-0232
- Status last verified
- 24 May 2011
- First submitted
- 23 Aug 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Bartoshuk LM, Duffy VB, Green BG, Hoffman HJ, Ko CW, Lucchina LA, Marks LE, Snyder DJ, Weiffenbach JM. Valid across-group comparisons with labeled scales: the gLMS versus magnitude matching. Physiol Behav. 2004 Aug;82(1):109-14. doi: 10.1016/j.physbeh.2004.02.033.
PubMed 15234598Bliss 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 6934713Garcia-Perez MA. Forced-choice staircases with fixed step sizes: asymptotic and small-sample properties. Vision Res. 1998 Jun;38(12):1861-81. doi: 10.1016/s0042-6989(97)00340-4.
PubMed 9797963
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
- Hypersensitivity in Tourette Syndrome: An Evaluation of Perceived Intensity Versus Threshold
- ClinicalTrials.gov ID
- NCT00368433
- Acronym / sponsor ID
- 060232
- Conditions
- Tourette's Syndrome
- Keywords
- Sensory Processing, Electromyogram, Tic Disorder, Tourette Syndrome, Tourette's Syndrome, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 21 Aug 2006
- Study completion
- 24 May 2011
- First posted
- 24 Aug 2006 (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 investigate how the sensitivity to touch and smell in patients with Tourette syndrome (TS) may differ from that of people without TS. TS is a neurological disorder that causes people to have uncontrolled movements called "tics." A tic can also be vocal, like a cough or bark or string of bad words. The tic is preceded by a "premonitory urge" that may feel like an itch or pressure that builds until the tic occurs. To some patients, the tic feels like a response to an involuntary sensation. In patients with TS, sensory information may be processed differently than it is in people without TS. This study will compare how strong a sensation feels in TS patients and healthy volunteers. It will also look for muscle activity that may be responsible for the feelings in the area of the tic.
Healthy normal volunteers and people with Tourette syndrome, 18 to 65 years of age, may be eligible for this study. Candidates are screened with a medical history and brief physical and neurological examinations. TS patients complete a questionnaire about their tics and are interviewed by a psychiatrist. Women who can become pregnant will have a urine pregnancy test prior to any other procedures. Pregnant women cannot participate.
All participants undergo sensory testing for touch and smell. They are asked to distinguish between a scented and scentless object and rate how strongly they feel the scent. Later, with their eyes closed, they are asked to tell whether or not they are being touched, and to rate how intensely they felt the touch.
In addition to the sensory testing, TS patients, but not normal volunteers, undergo electromyography (EMG), a test that measures the electrical activity of muscles. For surface EMG, small metal disks called electrodes are filled with a conductive gel and taped to the skin. Wire EMG involves inserting a wire into a muscle using a needle. All patients have surface EMG and those who consent to it will also have wire EMG.
Detailed description
OBJECTIVE:
This study will explore sensory phenomena associated with Tourette syndrome (TS). The first part will evaluate threshold levels versus perceived intensity of tactile and olfactory stimuli in areas reported to be hypersensitive in TS patients. The second part will use electromyography (EMG) to seek correlation between muscle activity and the perceived intensity of "urge" in focal areas of premonitory sensations.
STUDY POPULATION:
Twenty-six patients and 22 control subjects will be studied. Subjects can be of any race, gender, handedness, or age from 18 to 65 years.
DESIGN:
To determine olfactory and tactile threshold, n-butanol and Von Frey hairs will be presented in forced-choice modified method of limits paradigms. Perceived intensity will be examined using a generalized labeled magnitude scale (gLMS), whose word values are placed on a ruler for numerical reporting. Randomly arranged series of 7 stimuli for olfaction and touch will be presented in 4 sets, and subjects will report a number on the gLMS that corresponds to the intensity of each sensation. Both threshold and intensity will be measured in the peroneal nerve territory in all subjects, and at one other variable place, which will be matched 1:1 between patients and controls. The variable spot will consist of a patient's sensory tic site. Next, EMG activity will be measured from up to 8 muscles in the area of a sensory tic. Patients will report when a sensory tic is occurring, and will be asked to resist the motor tic for at least 12 seconds from that point. Total EMG activity will be measured in muscles surrounding the sensation at 1, 4, and 7 seconds before and after the tic.
OUTCOME MEASURES:
Outcome measures include the sensory threshold values for olfaction and touch and the reported intensity values. The outcome measures of the EMG study include the power of total EMG activity at time points before and after a tic.
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Volunteers ages 18 to 65 who have who have given their consent.
- Patients will be ages 18 to 65 and have clinically documented Tourette's syndrome or chronic motor tic disorder as defined by DSM-IV-TR (American Psychiatric Association, 2000) and evaluation of tic severity using the Yale Tic Scale (YGTS). 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 patients 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.
Key exclusion criteria (7 listed)
- Subjects younger than 18 or older than 65 years.
- Subjects with 1) major depression, 2) bipolar disorder, or 3) psychotic disorder.
- Subjects who are unable to abstain from alcohol or any psychiatric medications 24 hours prior to the study.
- Subjects with acute or chronic upper respiratory illness, nasal allergies, or subjects using medications to treat these conditions, including antihistamines, nasal topical steroids, vasoconstrictor nasal sprays, or normal saline sprays.
- Women who are pregnant.
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 15234598Bartoshuk LM, Duffy VB, Green BG, Hoffman HJ, Ko CW, Lucchina LA, Marks LE, Snyder DJ, Weiffenbach JM. Valid across-group comparisons with labeled scales: the gLMS versus magnitude matching. Physiol Behav. 2004 Aug;82(1):109-14. doi: 10.1016/j.physbeh.2004.02.033.
- 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.
- Background: PubMed 9797963Garcia-Perez MA. Forced-choice staircases with fixed step sizes: asymptotic and small-sample properties. Vision Res. 1998 Jun;38(12):1861-81. doi: 10.1016/s0042-6989(97)00340-4.
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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's 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 3 inclusion and 7 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 NCT00368433, which also lists 3 linked publications.
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.