Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00141869
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-08-31
Brief Title:
Brain Activity Associated With Tics in Patients With Tourette Syndrome
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
MEG Study of Altered Sensory Processing in Tourette Syndrome An Exploration of Sensory Tics
Status:
COMPLETED
Status Verified Date:
2007-09-06
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 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
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 025 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
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 025 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 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 |
|---|---|---|---|
| 05-N-0230 | None | None | None |