Focal DystoniaNCT00595439
Association Between Focal Dystonia and Complex Regional Pain Syndrome
An observational study of Focal Dystonia and Peripheral Nervous System Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Focal Dystonia, Peripheral Nervous System Disease
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2007to 5 Oct 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PATIENTS WITH FOCAL DYSTONIA (ONLY):
- Age 18 years or older
- Presence of FD and no CRPS
- PATIENTS WITH CRPS (ONLY):
- Age 18 years or older
- Presence of CRPS and no FD
Show all 9Show fewer
- PATIENTS WITH DYSTONIA AND CRPS (CRPS + DYSTONIA):
- Age 18 years or older
- Presence of FD and CRPS in the same limb
Who cannot join
- Concurrent significant medical, surgical, neurologic or psychiatric condition
- Taking the following medications: anxiolytics, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines
- Taking antidepressants or anticonvulsants needs to be discussed specifically in each patient
- Received botulinum toxin injection within 3 months of starting the protocol
- For TMS: Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye
- History of seizure disorder
Show all 9Show fewer
- No known history of hearing loss
- For MRI: Presence of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, or shrapnel fragments. Welders and metal workers are also at risk for injury because of possible small metal fragments in the eye of which they may be unaware.
- Pregnancy.
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: The Association Between Focal Dystonia (FD) and Complex Regional Pain Syndrome (CRPS)
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 1/4-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.
Read the 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, FD+CRPS, 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.
- Conditions
- Focal Dystonia, Peripheral Nervous System Disease
- Keywords
- Sensory Evoked Potentials (SEPs), Electromyogram, Transcranial Magnetic Stimulation (TMS), Complex Regional Pain Syndrome, Focal Hand Dystonia, Focal Dystonia, Chronic Regional Pain Syndrome, CRPS
- Medical subject headings
- Dystonic Disorders, Peripheral Nervous System Diseases, Complex Regional Pain Syndromes, Dystonia, Focal, Task-Specific
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study start21 Dec 2007
- Primary completion5 Oct 2009
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 Focal DystoniaStudies 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
- Time perspective
- Prospective
- Enrolment
- 90 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595439
- Sponsor's protocol ID
- 080040
- Other IDs
- 08-N-0040
- Status last verified
- 5 Oct 2009
- First submitted
- 28 Dec 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Hallett M. Dystonia: abnormal movements result from loss of inhibition. Adv Neurol. 2004;94:1-9. No abstract available.
PubMed 14509648Bressman SB. Dystonia genotypes, phenotypes, and classification. Adv Neurol. 2004;94:101-7. No abstract available.
PubMed 14509661Rothwell JC, Obeso JA, Day BL, Marsden CD. Pathophysiology of dystonias. Adv Neurol. 1983;39:851-63. No abstract available.
PubMed 6660125
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
- The Association Between Focal Dystonia (FD) and Complex Regional Pain Syndrome (CRPS)
- ClinicalTrials.gov ID
- NCT00595439
- Acronym / sponsor ID
- 080040
- Conditions
- Focal Dystonia, Peripheral Nervous System Disease
- Keywords
- Sensory Evoked Potentials (SEPs), Electromyogram, Transcranial Magnetic Stimulation (TMS), Complex Regional Pain Syndrome, Focal Hand Dystonia, Focal Dystonia, Chronic Regional Pain Syndrome, CRPS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 21 Dec 2007
- Primary completion
- 5 Oct 2009 (actual)
- First posted
- 16 Jan 2008 (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 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 1/4-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, FD+CRPS, 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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older
- Presence of FD and no CRPS
- Age 18 years or older
- Presence of CRPS and no FD
- Age 18 years or older
Key exclusion criteria (9 listed)
- Concurrent significant medical, surgical, neurologic or psychiatric condition
- Taking the following medications: anxiolytics, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines
- Taking antidepressants or anticonvulsants needs to be discussed specifically in each patient
- Received botulinum toxin injection within 3 months of starting the protocol
- For TMS: Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye
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 14509648Hallett M. Dystonia: abnormal movements result from loss of inhibition. Adv Neurol. 2004;94:1-9. No abstract available.
- Background: PubMed 14509661Bressman SB. Dystonia genotypes, phenotypes, and classification. Adv Neurol. 2004;94:101-7. No abstract available.
- Background: PubMed 6660125Rothwell JC, Obeso JA, Day BL, Marsden CD. Pathophysiology of dystonias. Adv Neurol. 1983;39:851-63. No abstract available.
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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 Focal Dystonia and Peripheral Nervous System Disease, 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 9 inclusion and 9 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 NCT00595439, 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.