DystoniaNCT00031369
Brain Anatomy in Dystonia
An observational study of Dystonia and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will use high-resolution magnetic resonance imaging (MRI) to look for subtle differences in brain anatomy between patients with focal hand dystonia (also called writer s cramp) and healthy normal volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2002to 10 Mar 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HEALTHY VOLUNTEERS: Healthy volunteers who consented to participate in the study and matched for age, sex, handedness with the group of patients with primary focal hand dystonia.
- PATIENTS: Patient with primary focal dystonia from our dystonia patient database who consented to participate in the study. This criterion will be established by the preliminary screening in the Human Motor Control Outpatient Clinic.
Who cannot join
- The following subjects will be excluded:
- Healthy volunteers with cognitive complaints, abnormal neurological exam or history of past neurological disease.
- Dystonia patients with the presence of a second neurological disease or condition; abnormal neurological findings on exam that are not related to primary focal dystonia.
- Subjects with past or present neuropsychiatric illness, head trauma with loss of consciousness, epilepsy, cerebro-vascular disease, migraine, past and present history of alcohol abuse, medical conditions that may alter cerebral structure.
- Subjects with abnormal MRI findings at visual inspection (prominent normal variants such as mega cisterna or cavum septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumors, vascular diseases, trauma or AVMs).
- Subjects with any metallic objects within them just prior to MR imaging (cardiac or neural pacemaker, aneurysm clips [metal clips on the wall of a large artery], metallic prostheses [including heart valves and cochlear implants] or shrapnel fragments. Welders and metal workers are also at risk for injury and may not take part in the study because of possible small metal fragments in the eye of which they may be unaware.
Show all 9Show fewer
- Subjects not capable of giving an informed consent.
- Women who are pregnant
- Children
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: In Vivo Mapping Of Structural and Biochemical Abnormalities In Patients With Primary Focal Dystonia
This study will use high-resolution magnetic resonance imaging (MRI) to look for subtle differences in brain anatomy between patients with focal hand dystonia (also called writer s cramp) and healthy normal volunteers. Patients with hand dystonia have prolonged muscle contractions that cause sustained twisting movements and abnormal postures. These abnormal movements often occur with activities such as writing, typing, playing certain musical instruments such as guitar or piano, or playing golf or darts.
Patients with focal hand dystonia and healthy volunteers will be enrolled in this study. Patients will be recruited from NINDS s database of patients with focal hand dystonia. Volunteers will be selected to match the patients in age, sex and handedness.
Read more
This study involves two visits to the NIH Clinical Center. The first visit is a screening visit, in which patients and volunteers will have a medical history, physical examination, neurological examination, and assessment of handedness. Women of childbearing age will be screened with a pregnancy test. Pregnant women are exclude from this study.
Those who join the study will return for a second visit for magnetic resonance imaging. MRI uses a magnetic field and radio waves to produce images of the brain. For the procedure, the participant lies still on a stretcher that is moved into the scanner (a narrow cylinder containing the magnet). Earplugs are worn to muffle loud noises caused by electrical switching of radio frequency circuits used in the scanning process. The scan will last about 45 to 60 minutes, at most. Some volunteers may be asked to return for a third visit to obtain a second MRI on a different scanner.
Read the detailed description
Objective
The term, dystonia, is used to describe a syndrome characterized by prolonged muscle contractions causing sustained twisting movements and abnormal postures of the affected body part(s). Although no structural brain abnormalities have been definitively demonstrated in the visual inspection of MRI scans from patients with primary focal dystonia, there are several lines of evidence for subtle structural brain abnormalities at both the subcortical and cortical levels. We hypothesize that those abnormalities might be detected by using appropriate acquisition and analysis methods.
Study population
This research will be conducted using patients with primary focal dystonia and normal volunteers.
Design
By using high-resolution 3D structural magnetic resonance imaging (MRI) of the brain and voxel-based morphometry (VBM), and diffusion tensor imaging (DTI) at 3 Tesla and high resolution anatomical images at 7 Tesla, we will detect structural changes in patients with primary focal dystonia in comparison with control subjects. VBM and DTI are methods implemented in the statistical parametric mapping software (SPM2). Magnetic resonance spectroscopy (MRS) will use special software to calculate gamma-aminobutyric acid (GABA) levels in a region of interest.
Outcome measures
VBM and DTI analysis in SPM2 will enable us to make a voxel-wise comparison of local concentration/volume of gray/white matter among these groups of subjects. This study can lead to an improved knowledge of the pathophysiology of primary hand dystonia can help to elucidate dystonia s pathogenesis/etiology and may lead to specific preventative or therapeutic approaches. The MRS study will enable us to study GABA levels in the sensory motor cortices, prefrontal cortex and basal ganglia in primary dystonia patients and normal subjects.
- Keywords
- MRI, Writer's Cramp, Movement Disorder, Gray Matter, Brain Morphology, Dystonia, Focal Hand Dystonia, Healthy Volunteer, HV, Normal Control
- Medical subject headings
- Dystonia, Dystonic Disorders, Movement Disorders, 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 posted4 Mar 2002 (estimated)
- Study start27 Feb 2002
- Study completion10 Mar 2015
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 DystoniaStudies 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
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031369
- Sponsor's protocol ID
- 020132
- Other IDs
- 02-N-0132
- Status last verified
- 10 Mar 2015
- First submitted
- 2 Mar 2002
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Berardelli A, Rothwell JC, Hallett M, Thompson PD, Manfredi M, Marsden CD. The pathophysiology of primary dystonia. Brain. 1998 Jul;121 ( Pt 7):1195-212. doi: 10.1093/brain/121.7.1195.
PubMed 9679773Bhatia KP, Marsden CD. The behavioural and motor consequences of focal lesions of the basal ganglia in man. Brain. 1994 Aug;117 ( Pt 4):859-76. doi: 10.1093/brain/117.4.859.
PubMed 7922471Lee MS, Marsden CD. Movement disorders following lesions of the thalamus or subthalamic region. Mov Disord. 1994 Sep;9(5):493-507. doi: 10.1002/mds.870090502.
PubMed 7990845
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Mapping Of Structural and Biochemical Abnormalities In Patients With Primary Focal Dystonia
- ClinicalTrials.gov ID
- NCT00031369
- Acronym / sponsor ID
- 020132
- Keywords
- MRI, Writer's Cramp, Movement Disorder, Gray Matter, Brain Morphology, Dystonia, Focal Hand Dystonia, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 189 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 27 Feb 2002
- Study completion
- 10 Mar 2015
- First posted
- 4 Mar 2002 (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 use high-resolution magnetic resonance imaging (MRI) to look for subtle differences in brain anatomy between patients with focal hand dystonia (also called writer s cramp) and healthy normal volunteers. Patients with hand dystonia have prolonged muscle contractions that cause sustained twisting movements and abnormal postures. These abnormal movements often occur with activities such as writing, typing, playing certain musical instruments such as guitar or piano, or playing golf or darts.
Patients with focal hand dystonia and healthy volunteers will be enrolled in this study. Patients will be recruited from NINDS s database of patients with focal hand dystonia. Volunteers will be selected to match the patients in age, sex and handedness.
This study involves two visits to the NIH Clinical Center. The first visit is a screening visit, in which patients and volunteers will have a medical history, physical examination, neurological examination, and assessment of handedness. Women of childbearing age will be screened with a pregnancy test. Pregnant women are exclude from this study.
Those who join the study will return for a second visit for magnetic resonance imaging. MRI uses a magnetic field and radio waves to produce images of the brain. For the procedure, the participant lies still on a stretcher that is moved into the scanner (a narrow cylinder containing the magnet). Earplugs are worn to muffle loud noises caused by electrical switching of radio frequency circuits used in the scanning process. The scan will last about 45 to 60 minutes, at most. Some volunteers may be asked to return for a third visit to obtain a second MRI on a different scanner.
Detailed description
Objective
The term, dystonia, is used to describe a syndrome characterized by prolonged muscle contractions causing sustained twisting movements and abnormal postures of the affected body part(s). Although no structural brain abnormalities have been definitively demonstrated in the visual inspection of MRI scans from patients with primary focal dystonia, there are several lines of evidence for subtle structural brain abnormalities at both the subcortical and cortical levels. We hypothesize that those abnormalities might be detected by using appropriate acquisition and analysis methods.
Study population
This research will be conducted using patients with primary focal dystonia and normal volunteers.
Design
By using high-resolution 3D structural magnetic resonance imaging (MRI) of the brain and voxel-based morphometry (VBM), and diffusion tensor imaging (DTI) at 3 Tesla and high resolution anatomical images at 7 Tesla, we will detect structural changes in patients with primary focal dystonia in comparison with control subjects. VBM and DTI are methods implemented in the statistical parametric mapping software (SPM2). Magnetic resonance spectroscopy (MRS) will use special software to calculate gamma-aminobutyric acid (GABA) levels in a region of interest.
Outcome measures
VBM and DTI analysis in SPM2 will enable us to make a voxel-wise comparison of local concentration/volume of gray/white matter among these groups of subjects. This study can lead to an improved knowledge of the pathophysiology of primary hand dystonia can help to elucidate dystonia s pathogenesis/etiology and may lead to specific preventative or therapeutic approaches. The MRS study will enable us to study GABA levels in the sensory motor cortices, prefrontal cortex and basal ganglia in primary dystonia patients and normal subjects.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HEALTHY VOLUNTEERS: Healthy volunteers who consented to participate in the study and matched for age, sex, handedness with the group of patients with primary focal hand dystonia.
- PATIENTS: Patient with primary focal dystonia from our dystonia patient database who consented to participate in the study. This criterion will be established by the preliminary screening in the Human Motor Control Outpatient Clinic.
Key exclusion criteria (9 listed)
- Healthy volunteers with cognitive complaints, abnormal neurological exam or history of past neurological disease.
- Dystonia patients with the presence of a second neurological disease or condition; abnormal neurological findings on exam that are not related to primary focal dystonia.
- Subjects with past or present neuropsychiatric illness, head trauma with loss of consciousness, epilepsy, cerebro-vascular disease, migraine, past and present history of alcohol abuse, medical conditions that may alter cerebral structure.
- Subjects with abnormal MRI findings at visual inspection (prominent normal variants such as mega cisterna or cavum septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumors, vascular diseases, trauma or AVMs).
- Subjects with any metallic objects within them just prior to MR imaging (cardiac or neural pacemaker, aneurysm clips [metal clips on the wall of a large artery], metallic prostheses [including heart valves and cochlear implants] or shrapnel fragments. Welders and metal workers are also at risk for injury and may not take part in the study because of possible small metal fragments in the eye of which they may be unaware.
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 was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 9679773Berardelli A, Rothwell JC, Hallett M, Thompson PD, Manfredi M, Marsden CD. The pathophysiology of primary dystonia. Brain. 1998 Jul;121 ( Pt 7):1195-212. doi: 10.1093/brain/121.7.1195.
- Background: PubMed 7922471Bhatia KP, Marsden CD. The behavioural and motor consequences of focal lesions of the basal ganglia in man. Brain. 1994 Aug;117 ( Pt 4):859-76. doi: 10.1093/brain/117.4.859.
- Background: PubMed 7990845Lee MS, Marsden CD. Movement disorders following lesions of the thalamus or subthalamic region. Mov Disord. 1994 Sep;9(5):493-507. doi: 10.1002/mds.870090502.
Related trials for Dystonia
Active, not recruitingPhase 1/2
Deep Brain Stimulation Surgery for Focal Hand Dystonia
Dystonia, Focal Dystonia
RecruitingObservational study
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
Dystonia, Parkinsonism
Active, not recruiting
Accelerated TMS for Focal Hand Dystonia
Isolated Focal Hand Dystonia
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
Dystonia
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.
Mark Hallett, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 Dystonia and Healthy, 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 2 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: stopped early, as of the sponsor's last update on 6 Oct 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 was stopped early. Results are not available in the source record.
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 NCT00031369, 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 6 Oct 2017.