Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368433
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-08-23
Brief Title:
Hypersensitivity in Tourette Syndrome
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Hypersensitivity in Tourette Syndrome An Evaluation of Perceived Intensity Versus Threshold
Status:
COMPLETED
Status Verified Date:
2011-05-24
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 11 between patients and controls The variable spot will consist of a patients 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
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 11 between patients and controls The variable spot will consist of a patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-N-0232 | None | None | None |