CompletedNot Applicable

Validating a New Writer s Cramp Scale

United States16 participantsStarted 2012-03-21

Plain-language 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. 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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: * 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 EXCLUSION CRITERIA: * 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: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT01579266

SponsorNational Institute of Neurological Disorders and Stroke (NINDS)

Sponsor typeNIH

Study typeOBSERVATIONAL

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