DystoniaNCT01579266
Validating a New Writer s Cramp Scale
An observational study of Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: People with writer s cramp develop tightness in arm muscles and abnormal hand posture when writing, which makes writing difficult or impossible. At present, there is no suitable rating scale to measure the symptoms of or disability associated with writer s cramp. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dystonia
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2012to 25 Oct 2016
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria for patients with WC and age and handedness-matched HVs:
- Subjects must be at least 18 years of age.
- Subjects must be willing to be videotaped while writing.
- Subjects must have regular hand function with the ability to write without an assistive device
Who cannot join
- Patients with WC:
- Botulinum toxin (BTX) administration within 3 months of participation.
- Unable to provide consent.
- Patients taking oral medications for WC including muscle relaxants or other centrally-active medications such as antidepressants which may enhance tremors.
- Medical conditions that affect hand function, such as stroke, nerve entrapment, tremor, parkinsonism, chorea, ataxia affecting the dominant hand.
- HVs:
Show all 11Show fewer
- Unable to provide consent.
- Healthy volunteers taking oral medications that may affect motor function such as muscle relaxants or centrally-active medications including medications for psychiatric conditions like antidepressants and antipsychotics.
- Healthy volunteers with abnormal hand function including medical conditions that may influence hand function, e.g., strokes, nerve entrapments, tremor, parkinsonism, chorea, ataxia and psychiatric conditions (such as psychosis and depression) affecting the dominant hand.
- Have history of hand surgery and or hand trauma.
- Have abnormal findings on medical history and physical exam.
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: Validating a New Writer's Cramp Scale
Background:
- People with writer s cramp develop tightness in arm muscles and abnormal hand posture when writing, which makes writing difficult or impossible. At present, there is no suitable rating scale to measure the symptoms of or disability associated with writer s cramp. Researchers want to videotape people performing simple writing tasks. They will then compare the performance of people with writer s cramp on these tasks to those of people without writer s cramp. This information will help develop a rating scale to evaluate writer s cramp.
Read more
Objectives:
- To develop a new rating scale for writer s cramp.
Eligibility:
- Individuals at least 18 years of age who have writer s cramp.
Design:
- Participants will be screened with a physical exam and medical history.
- Participants will have one outpatient study visit that will last about 3 hours.
- Participants will perform tasks related to writing, such as writing passages and drawing spirals and loops. They will be videotaped during these tasks. They will repeat some of the writing tasks three more times; on paper attached to a writing tablet, directly on the writing tablet, and on a computer tablet.
- The angles made by the joints will be measured at rest not while writing healthy volunteers.
Read the detailed description
Objective: Writer s cramp (WC) causes significant discomfort and disability to those afflicted by this condition. Studies on WC have been hampered by the lack of objective, validated rating scales. In this study, we will test and validate new instruments to rate WC; the WC impairment scale (WCIS) and a new disability scale (WCDS).We will also collect exploratory data about biomechanics of the hand.
Study population: The study population will consist of 20 subjects. Ten patients with WC and 10 age and handedness matched HVs will constitute the study population.
Design: 10 patients with WC and 10 age- and handedness-matched HV will be videotaped while writing. The WCIS scores will be given to each subject by four blinded raters (Drs. Mark Hallett, Barbara Karp, Katherine Alter, and Camilo Toro) based on the videos. The patients will complete the WCDS. In addition, each individual will be asked to repeat some basic elements of the scale while writing on the screen of a tablet PC, and on the surface of a detached digitizing tablet in order to generate high temporal and spatial resolution pen tip position samples for further numerical analyses and scoring. The biomechanics of the hand will be measured using a published scale.
Outcome measures: Using the WCIS, inter and intra-rater reliability, internal consistency (Cronbach s alpha) face validity, and reproducibility will be measured in addition to other secondary outcomes. The ease of use by the raters will be assessed for each subject. Reproducibility of writing on tablet, writing on paper placed on a writing tablet, and writing on a tablet PC will be assessed. Finally, biomechanics of the hands of patients with WC will be compared with those of the unaffected healthy volunteers.
- Conditions
- Dystonia
- Keywords
- Writer's Cramp, Focal Hand Dystonia, Writer Cramp, Dystonia
- Medical subject headings
- Dystonia, 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 posted17 Apr 2012 (estimated)
- Study start21 Mar 2012
- Study completion25 Oct 2016
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
- Time perspective
- Prospective
- Enrolment
- 16 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
- NCT01579266
- Sponsor's protocol ID
- 120104
- Other IDs
- 12-N-0104
- Status last verified
- 25 Oct 2016
- First submitted
- 14 Apr 2012
- Last updated
- 22 Oct 2019
- Results posted
- No
Publications
Wissel J, Kabus C, Wenzel R, Klepsch S, Schwarz U, Nebe A, Schelosky L, Scholz U, Poewe W. Botulinum toxin in writer's cramp: objective response evaluation in 31 patients. J Neurol Neurosurg Psychiatry. 1996 Aug;61(2):172-5. doi: 10.1136/jnnp.61.2.172.
PubMed 8708685Pekmezovic T, Svetel M, Ivanovic N, Dragasevic N, Petrovic I, Tepavcevic DK, Kostic VS. Quality of life in patients with focal dystonia. Clin Neurol Neurosurg. 2009 Feb;111(2):161-4. doi: 10.1016/j.clineuro.2008.09.023. Epub 2008 Nov 7.
PubMed 18995953Burke RE, Fahn S, Marsden CD, Bressman SB, Moskowitz C, Friedman J. Validity and reliability of a rating scale for the primary torsion dystonias. Neurology. 1985 Jan;35(1):73-7. doi: 10.1212/wnl.35.1.73.
PubMed 3966004
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating a New Writer's Cramp Scale
- ClinicalTrials.gov ID
- NCT01579266
- Acronym / sponsor ID
- 120104
- Conditions
- Dystonia
- Keywords
- Writer's Cramp, Focal Hand Dystonia, Writer Cramp, Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 21 Mar 2012
- Study completion
- 25 Oct 2016
- First posted
- 17 Apr 2012 (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.
Background:
- People with writer s cramp develop tightness in arm muscles and abnormal hand posture when writing, which makes writing difficult or impossible. At present, there is no suitable rating scale to measure the symptoms of or disability associated with writer s cramp. Researchers want to videotape people performing simple writing tasks. They will then compare the performance of people with writer s cramp on these tasks to those of people without writer s cramp. This information will help develop a rating scale to evaluate writer s cramp.
Objectives:
- To develop a new rating scale for writer s cramp.
Eligibility:
- Individuals at least 18 years of age who have writer s cramp.
Design:
- Participants will be screened with a physical exam and medical history.
- Participants will have one outpatient study visit that will last about 3 hours.
- Participants will perform tasks related to writing, such as writing passages and drawing spirals and loops. They will be videotaped during these tasks. They will repeat some of the writing tasks three more times; on paper attached to a writing tablet, directly on the writing tablet, and on a computer tablet.
- The angles made by the joints will be measured at rest not while writing healthy volunteers.
Detailed description
Objective: Writer s cramp (WC) causes significant discomfort and disability to those afflicted by this condition. Studies on WC have been hampered by the lack of objective, validated rating scales. In this study, we will test and validate new instruments to rate WC; the WC impairment scale (WCIS) and a new disability scale (WCDS).We will also collect exploratory data about biomechanics of the hand.
Study population: The study population will consist of 20 subjects. Ten patients with WC and 10 age and handedness matched HVs will constitute the study population.
Design: 10 patients with WC and 10 age- and handedness-matched HV will be videotaped while writing. The WCIS scores will be given to each subject by four blinded raters (Drs. Mark Hallett, Barbara Karp, Katherine Alter, and Camilo Toro) based on the videos. The patients will complete the WCDS. In addition, each individual will be asked to repeat some basic elements of the scale while writing on the screen of a tablet PC, and on the surface of a detached digitizing tablet in order to generate high temporal and spatial resolution pen tip position samples for further numerical analyses and scoring. The biomechanics of the hand will be measured using a published scale.
Outcome measures: Using the WCIS, inter and intra-rater reliability, internal consistency (Cronbach s alpha) face validity, and reproducibility will be measured in addition to other secondary outcomes. The ease of use by the raters will be assessed for each subject. Reproducibility of writing on tablet, writing on paper placed on a writing tablet, and writing on a tablet PC will be assessed. Finally, biomechanics of the hands of patients with WC will be compared with those of the unaffected healthy volunteers.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Inclusion criteria for patients with WC and age and handedness-matched HVs:
Key exclusion criteria (11 listed)
- Patients with WC:
- HVs:
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 22 Oct 2019.
- Background: PubMed 8708685Wissel J, Kabus C, Wenzel R, Klepsch S, Schwarz U, Nebe A, Schelosky L, Scholz U, Poewe W. Botulinum toxin in writer's cramp: objective response evaluation in 31 patients. J Neurol Neurosurg Psychiatry. 1996 Aug;61(2):172-5. doi: 10.1136/jnnp.61.2.172.
- Background: PubMed 18995953Pekmezovic T, Svetel M, Ivanovic N, Dragasevic N, Petrovic I, Tepavcevic DK, Kostic VS. Quality of life in patients with focal dystonia. Clin Neurol Neurosurg. 2009 Feb;111(2):161-4. doi: 10.1016/j.clineuro.2008.09.023. Epub 2008 Nov 7.
- Background: PubMed 3966004Burke RE, Fahn S, Marsden CD, Bressman SB, Moskowitz C, Friedman J. Validity and reliability of a rating scale for the primary torsion dystonias. Neurology. 1985 Jan;35(1):73-7. doi: 10.1212/wnl.35.1.73.
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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.
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, 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 4 inclusion and 11 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 22 Oct 2019. 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 NCT01579266, 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 22 Oct 2019.