Focal DystoniaNCT00310414
fMRI Studies of Task Specificity in Focal Hand Dystonia
An observational study of Focal Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine how the brain makes involuntary spasms and contractions in patients with focal hand dystonia (FHD). Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In FHD, only the hand is involved. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Focal Dystonia
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2006to 13 Mar 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Focal Dystonia Subjects must be:
- Right hand dominant
- Between 18 and 65 years old
- Diagnosed with mild, simple focal hand dystonia. For this study mild, simple focal hand dystonia suggests that the patient does not present symptoms when performing tasks other than writing. Additionally, the patient should be able to write for 20 seconds consecutively
- Willing to abstain from alcohol 48 hours prior to the study
- Volunteers must be:
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- Healthy right-handed dominant individuals
- Between 18 and 65 years old
- Willing to abstain from alcohol 48 hours prior to the study
Who cannot join
- Subjects with implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except mouth, intracardiac lines, history of shrapnel injury or any other condition/device that may be contraindicated or prevent the acquisition of MRI
- Subjects with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan
- Subjects who are pregnant.
- Subjects with claustrophobia or other restrictions which prevent them from undergoing a scan in a confined space for up to 60 minutes
- Subjects with any visual, motor, or hearing difficulties
- Subjects with severe focal hand dystonia i.e., subjects who experience dystonic spasms in tasks other than/in addition to writing
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- Subjects with mirror dystonia
- Subjects without the capacity to give consent
- Subjects with any history of a severe medical condition, such as cardiovascular disease, which will prevent them from lying flat for up to 60 minutes.
- Subjects with any history of brain tumor, stroke, head trauma or vascular malformation as obtained by history or from imaging studies.
- Subjects who have had recent (within 3 months) Botulinum Toxin (Botox) injections.
- Subjects who are on anti-parkinsonian drugs
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
This study will examine how the brain makes involuntary spasms and contractions in patients with focal hand dystonia (FHD). Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In FHD, only the hand is involved. The study will use functional magnetic resonance imaging (fMRI, see below) to study which areas of the brain are primarily affected in FHD and better understand how brain changes produce dystonia symptoms.
Normal right-handed volunteers and patients with FHD who are 18-65 years of age may be eligible for this study. Candidates are screened with a medical history and physical and neurological examinations. Women who can become pregnant have a urine pregnancy test.
All participants undergo fMRI. This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies on a table that is moved into the scanner (a metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 90 minutes, during which time the patient is asked to lie still for 10-15 minutes at a time. During the procedure, subjects are asked to perform some tasks, including writing, tapping with their hand, and drawing in a zigzag motion. Each task is performed using the right hand, left hand and right foot.
Read the detailed description
Objective:
Writer's cramp, a form of focal hand dystonia, is the most frequently observed task specific dystonia. Symptoms of writer's cramp often appear as soon as the pen is picked up, or after a few words of writing. Patients with simple writer's cramp have difficulties writing, but carry out other tasks with the affected hand without spasms. Little is known about why the hand spasms when writing, while performing other tasks normally.
The purpose of this study is to identify brain areas of activation associated specifically with the task of handwriting with the dystonic hand, in patients with simple writer's cramp. Simple writer's cramp can be defined by a patient exhibiting the symptoms only when writing and symptoms are not present in any other task performance. Specifically for this study, patients should be able to write for 20 seconds consecutively in a run. We plan to use functional magnetic resonance imaging (fMRI) to identify the pattern of blood oxygenation level-dependent (BOLD) activation in the brain when different tasks are performed by different limbs in healthy volunteers and patients with focal hand dystonia.
Study Population:
This research will be conducted using 22 patients diagnosed with simple writer's cramp and 32 healthy volunteers matched for age and gender.
Design:
Using a block design in functional magnetic resonance imaging (fMRI), we will examine the brain activity of patients and healthy volunteers while they execute three tasks: writing, tapping and a zigzagging motion, with three separate limbs: the dystonic hand, the opposite hand, and the right foot.
Outcome Measures:
The changes in signal intensity of the brain activity correlated with the motor program (task of handwriting) and effector (dystonic hand) will be collected and analyzed.
The findings we expect to obtain with this experiment may contribute to basic knowledge of the linkage between task specificity and the dystonic hand, and may provide a better understanding of the pathophysiology of writer's cramp.
- Conditions
- Focal Dystonia
- Keywords
- Imaging Studies, Botulinum Toxin, Writer's Cramp, Focal Hand Dystonia, FHD, Writer Cramp, Healthy Volunteer, HV
- Medical subject headings
- Dystonic 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 posted3 Apr 2006 (estimated)
- Study start30 Mar 2006
- Study completion13 Mar 2012
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
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Kenneth H Fischbeck, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310414
- Sponsor's protocol ID
- 060128
- Other IDs
- 06-N-0128
- Status last verified
- 13 Mar 2012
- First submitted
- 31 Mar 2006
- Last updated
- 2 Jul 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 9679773Butterworth S, Francis S, Kelly E, McGlone F, Bowtell R, Sawle GV. Abnormal cortical sensory activation in dystonia: an fMRI study. Mov Disord. 2003 Jun;18(6):673-82. doi: 10.1002/mds.10416.
PubMed 12784271Blood AJ, Flaherty AW, Choi JK, Hochberg FH, Greve DN, Bonmassar G, Rosen BR, Jenkins BG. Basal ganglia activity remains elevated after movement in focal hand dystonia. Ann Neurol. 2004 May;55(5):744-8. doi: 10.1002/ana.20108.
PubMed 15122718
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
- fMRI Studies of Task Specificity in Focal Hand Dystonia
- ClinicalTrials.gov ID
- NCT00310414
- Acronym / sponsor ID
- 060128
- Conditions
- Focal Dystonia
- Keywords
- Imaging Studies, Botulinum Toxin, Writer's Cramp, Focal Hand Dystonia, FHD, Writer Cramp, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 30 Mar 2006
- Study completion
- 13 Mar 2012
- First posted
- 3 Apr 2006 (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 examine how the brain makes involuntary spasms and contractions in patients with focal hand dystonia (FHD). Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In FHD, only the hand is involved. The study will use functional magnetic resonance imaging (fMRI, see below) to study which areas of the brain are primarily affected in FHD and better understand how brain changes produce dystonia symptoms.
Normal right-handed volunteers and patients with FHD who are 18-65 years of age may be eligible for this study. Candidates are screened with a medical history and physical and neurological examinations. Women who can become pregnant have a urine pregnancy test.
All participants undergo fMRI. This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies on a table that is moved into the scanner (a metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 90 minutes, during which time the patient is asked to lie still for 10-15 minutes at a time. During the procedure, subjects are asked to perform some tasks, including writing, tapping with their hand, and drawing in a zigzag motion. Each task is performed using the right hand, left hand and right foot.
Detailed description
Objective:
Writer's cramp, a form of focal hand dystonia, is the most frequently observed task specific dystonia. Symptoms of writer's cramp often appear as soon as the pen is picked up, or after a few words of writing. Patients with simple writer's cramp have difficulties writing, but carry out other tasks with the affected hand without spasms. Little is known about why the hand spasms when writing, while performing other tasks normally.
The purpose of this study is to identify brain areas of activation associated specifically with the task of handwriting with the dystonic hand, in patients with simple writer's cramp. Simple writer's cramp can be defined by a patient exhibiting the symptoms only when writing and symptoms are not present in any other task performance. Specifically for this study, patients should be able to write for 20 seconds consecutively in a run. We plan to use functional magnetic resonance imaging (fMRI) to identify the pattern of blood oxygenation level-dependent (BOLD) activation in the brain when different tasks are performed by different limbs in healthy volunteers and patients with focal hand dystonia.
Study Population:
This research will be conducted using 22 patients diagnosed with simple writer's cramp and 32 healthy volunteers matched for age and gender.
Design:
Using a block design in functional magnetic resonance imaging (fMRI), we will examine the brain activity of patients and healthy volunteers while they execute three tasks: writing, tapping and a zigzagging motion, with three separate limbs: the dystonic hand, the opposite hand, and the right foot.
Outcome Measures:
The changes in signal intensity of the brain activity correlated with the motor program (task of handwriting) and effector (dystonic hand) will be collected and analyzed.
The findings we expect to obtain with this experiment may contribute to basic knowledge of the linkage between task specificity and the dystonic hand, and may provide a better understanding of the pathophysiology of writer's cramp.
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Right hand dominant
- Between 18 and 65 years old
- Diagnosed with mild, simple focal hand dystonia. For this study mild, simple focal hand dystonia suggests that the patient does not present symptoms when performing tasks other than writing. Additionally, the patient should be able to write for 20 seconds consecutively
- Willing to abstain from alcohol 48 hours prior to the study
- Healthy right-handed dominant individuals
Key exclusion criteria (12 listed)
- Subjects with implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except mouth, intracardiac lines, history of shrapnel injury or any other condition/device that may be contraindicated or prevent the acquisition of MRI
- Subjects with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan
- Subjects who are pregnant.
- Subjects with claustrophobia or other restrictions which prevent them from undergoing a scan in a confined space for up to 60 minutes
- Subjects with any visual, motor, or hearing difficulties
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 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 12784271Butterworth S, Francis S, Kelly E, McGlone F, Bowtell R, Sawle GV. Abnormal cortical sensory activation in dystonia: an fMRI study. Mov Disord. 2003 Jun;18(6):673-82. doi: 10.1002/mds.10416.
- Background: PubMed 15122718Blood AJ, Flaherty AW, Choi JK, Hochberg FH, Greve DN, Bonmassar G, Rosen BR, Jenkins BG. Basal ganglia activity remains elevated after movement in focal hand dystonia. Ann Neurol. 2004 May;55(5):744-8. doi: 10.1002/ana.20108.
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Deep Brain Stimulation Surgery for Focal Hand Dystonia
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VTS Sensorimotor Neuromodulation in WC
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A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
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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.
Kenneth H Fischbeck, 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 Focal Dystonia, 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 12 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 NCT00310414, 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.