NCT01579266

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2016

Completed
Last Updated

October 22, 2019

Status Verified

October 25, 2016

First QC Date

April 14, 2012

Last Update Submit

October 19, 2019

Conditions

Keywords

Writer's CrampFocal Hand DystoniaWriter CrampDystonia

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 8708685BACKGROUND
  • Pekmezovic 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.

    PMID: 18995953BACKGROUND
  • Burke 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.

    PMID: 3966004BACKGROUND

MeSH Terms

Conditions

DystoniaDystonic DisordersDystonia, Focal, Task-Specific

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMovement DisordersCentral Nervous System Diseases

Study Officials

  • Mark Hallett, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2012

First Posted

April 17, 2012

Study Start

March 21, 2012

Study Completion

October 25, 2016

Last Updated

October 22, 2019

Record last verified: 2016-10-25

Locations