Ignite Creation Date:
2024-05-05 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 9:41 AM
Study NCT ID:
NCT00595439
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2007-12-28
Brief Title:
Association Between Focal Dystonia and Complex Regional Pain Syndrome
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Association Between Focal Dystonia FD and Complex Regional Pain Syndrome CRPS
Status:
COMPLETED
Status Verified Date:
2009-10-05
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 differences among people with focal dystonia FD complex regional pain syndrome CRPS and people who have both conditions to learn more about the cause of both disorders
Participants undergo the following procedures in five visits
Electroencephalography EEG Electrodes metal discs are placed on the scalp with an electrode cap a paste or a glue-like substance The spaces between the electrodes and the scalp are filled with a gel that conducts electrical activity Brain waves are recorded while the subject lies quietly and sensory stimulation is applied to the thumb or finger
Magnetic resonance imaging MRI This test uses a magnetic field and radio waves to obtain images of body tissues and organs The patient lies on a table that can slide in and out of the scanner wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process The procedure lasts about 45 minutes during which time the patient will be asked to lie still for up to 15 minutes at a time
Transcranial magnetic stimulation TMS An insulated wire coil is placed on the scalp and a brief electrical current is passed through the coil The current induces a magnetic field that stimulates the brain There may be a pulling sensation on the skin under the coil and a twitch in muscles of the face arm or leg During the stimulation subjects may be asked to keep their hands relaxed or to contract certain muscles
Peripheral electrical stimulation In two experiments TMS is combined with peripheral electrical stimulation similar to what is used in nerve conduction studies to the median nerve at the wrist There may be muscle twitching
Surface electromyography For TMS tests and peripheral electrical stimulation electrodes are filled with a conductive gel and taped to the skin to record the electrical activity of three muscles on the right hand
Needle EMG A needle is inserted into a muscle to record the electrical activity
Nerve conduction studies A probe is placed on the skin to deliver a small electrical stimulus and wires are taped to the skin record the nerve impulses These studies measure the speed with which nerves conduct electrical impulses and the strength of the connection between the nerve and the muscles
Skin biopsy Two sites are biopsied A local anesthetic is given to numb the area and a 14-inch piece of skin is removed with a special tool
JVP domes Subjects are tested for their ability to discriminate sensory stimuli in the affected region and on the other side of it They are asked to discriminate between stamps with grooves of different widths that are applied to the hands or feet
Participants undergo the following procedures in five visits
Electroencephalography EEG Electrodes metal discs are placed on the scalp with an electrode cap a paste or a glue-like substance The spaces between the electrodes and the scalp are filled with a gel that conducts electrical activity Brain waves are recorded while the subject lies quietly and sensory stimulation is applied to the thumb or finger
Magnetic resonance imaging MRI This test uses a magnetic field and radio waves to obtain images of body tissues and organs The patient lies on a table that can slide in and out of the scanner wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process The procedure lasts about 45 minutes during which time the patient will be asked to lie still for up to 15 minutes at a time
Transcranial magnetic stimulation TMS An insulated wire coil is placed on the scalp and a brief electrical current is passed through the coil The current induces a magnetic field that stimulates the brain There may be a pulling sensation on the skin under the coil and a twitch in muscles of the face arm or leg During the stimulation subjects may be asked to keep their hands relaxed or to contract certain muscles
Peripheral electrical stimulation In two experiments TMS is combined with peripheral electrical stimulation similar to what is used in nerve conduction studies to the median nerve at the wrist There may be muscle twitching
Surface electromyography For TMS tests and peripheral electrical stimulation electrodes are filled with a conductive gel and taped to the skin to record the electrical activity of three muscles on the right hand
Needle EMG A needle is inserted into a muscle to record the electrical activity
Nerve conduction studies A probe is placed on the skin to deliver a small electrical stimulus and wires are taped to the skin record the nerve impulses These studies measure the speed with which nerves conduct electrical impulses and the strength of the connection between the nerve and the muscles
Skin biopsy Two sites are biopsied A local anesthetic is given to numb the area and a 14-inch piece of skin is removed with a special tool
JVP domes Subjects are tested for their ability to discriminate sensory stimuli in the affected region and on the other side of it They are asked to discriminate between stamps with grooves of different widths that are applied to the hands or feet
Detailed Description:
OBJECTIVE
Dystonia is generally regarded as a motor execution abnormality due to a central nervous system dysfunction in the cortico-striato-thalamo-cortical motor loop Regional traumas are considered to be risk factors for the development of focal dystonia FD in the affected limb Since focal limb traumas are also associated with complex regional pain syndrome CRPS there may be a common underlying pathology in both conditions In CRPS many patients have a small fiber neuropathy The goal of the proposed research is to distinguish discriminate among the three disease categories FD FDCRPS CRPS to find out whether FD and CRPS share a common physiological substrate and represent two sides of a spectrum and to see which clinical situations may be secondary to an underlying small fiber neuropathy Independent studies will be conducted in patients with affected upper limbs and in those with affected lower limbs
STUDY POPULATION
We intend to perform two studies on overall 90 subjects One study will assess the affected upper limb in 15 patients with unilateral focal dystonia 15 patients with CRPS and 15 patients with focal dystonia and CRPS while the second study will test the affected lower limb in 15 patients with unilateral focal dystonia 15 patients with CRPS and 15 patients with focal dystonia and CRPS in the lower limb
DESIGN
We propose to explore the central aspects somatosensory evoked potentials SEPS and transcranial magnetic stimulation TMS in patients with upper limb disorders because the cortical representation of hand muscles is easier to study than the lower limb muscle representations In contrast the peripheral studies quantitative EMG and nerve conduction will be performed in patients with lower limb disorders due to length accessibility and separation of pure motor and sensory nerves in the leg
OUTCOME MEASURES
The primary outcome measure for the central nervous system features the upper limb assessment will be the difference in EEG dipole localization of the SEPs from thumb and index finger between the three groups to assess possible disturbances of cortical representation in the primary sensory cortex TMS measures will be exploratory
The primary outcome measure of the lower limb testing will be the duration of motor unit action potentials MUAP to assess differences and subtle lesions which were not picked up in clinical routine due to bigger confidence intervals of the single parameter
The unaffected side is the primary target of this study since we are looking for an underlying substrate however all clinical tests will be performed bilaterally if tolerated by the subjects and the comparison of both sides will be a secondary outcome measure
Dystonia is generally regarded as a motor execution abnormality due to a central nervous system dysfunction in the cortico-striato-thalamo-cortical motor loop Regional traumas are considered to be risk factors for the development of focal dystonia FD in the affected limb Since focal limb traumas are also associated with complex regional pain syndrome CRPS there may be a common underlying pathology in both conditions In CRPS many patients have a small fiber neuropathy The goal of the proposed research is to distinguish discriminate among the three disease categories FD FDCRPS CRPS to find out whether FD and CRPS share a common physiological substrate and represent two sides of a spectrum and to see which clinical situations may be secondary to an underlying small fiber neuropathy Independent studies will be conducted in patients with affected upper limbs and in those with affected lower limbs
STUDY POPULATION
We intend to perform two studies on overall 90 subjects One study will assess the affected upper limb in 15 patients with unilateral focal dystonia 15 patients with CRPS and 15 patients with focal dystonia and CRPS while the second study will test the affected lower limb in 15 patients with unilateral focal dystonia 15 patients with CRPS and 15 patients with focal dystonia and CRPS in the lower limb
DESIGN
We propose to explore the central aspects somatosensory evoked potentials SEPS and transcranial magnetic stimulation TMS in patients with upper limb disorders because the cortical representation of hand muscles is easier to study than the lower limb muscle representations In contrast the peripheral studies quantitative EMG and nerve conduction will be performed in patients with lower limb disorders due to length accessibility and separation of pure motor and sensory nerves in the leg
OUTCOME MEASURES
The primary outcome measure for the central nervous system features the upper limb assessment will be the difference in EEG dipole localization of the SEPs from thumb and index finger between the three groups to assess possible disturbances of cortical representation in the primary sensory cortex TMS measures will be exploratory
The primary outcome measure of the lower limb testing will be the duration of motor unit action potentials MUAP to assess differences and subtle lesions which were not picked up in clinical routine due to bigger confidence intervals of the single parameter
The unaffected side is the primary target of this study since we are looking for an underlying substrate however all clinical tests will be performed bilaterally if tolerated by the subjects and the comparison of both sides will be a secondary outcome measure
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 |
|---|---|---|---|
| 08-N-0040 | None | None | None |