Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02882295
Other study ID # SSA_2016_10
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 5, 2016
Est. completion date November 15, 2017

Study information

Verified date April 2022
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Writer's cramp (WC) is a task specific dystonia that occurs from the moment patient starts writing. It leads to partial or complete inability to use the hand only during the handwriting gesture. It is characterized by the appearance of cramps or spasms of certain muscles of the hand and/or forearm. Clinical scales currently use for the assessment of WC fail to accurately reflect changes in the characteristics of handwriting in response to treatments (Botulinum Neurotoxin injections and / or retraining therapy). The Zigzag Tracking Task (ZZTT), easy to use in current practice provides useful information in terms of speed and precision of handwriting gesture. This timed handwriting test is to follow with a pen a zigzag path beset with obstacles to avoid. It permits to evaluate the time in seconds required to carry out the zigzag path and count the number of errors (output path and contacts with obstacles). The investigators propose to validate the ZZTT for the assessment of the handwriting gesture of WC.


Recruitment information / eligibility

Status Terminated
Enrollment 23
Est. completion date November 15, 2017
Est. primary completion date November 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - scholarship in French language, at least until 16 years old - writer's cramp (diagnostic confirmed by a neurologist specialized in movement disorders) - prescription of botulinum neurotoxin injection - prescription de novo or absence of injection in the last 3 months - informed consent - medical insurance coverage Exclusion Criteria: - writing tremor - -other neurological disease with effect on handwriting - pain or traumatism of the upper limb, with effect on handwriting - non-corrected visual disturbances - patient living outside the region where the study will be held (Ile-de-France) - participation in another research with a potential impact on evaluation criteria - pregnant or breast feeding patient - patient under judiciary protection

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Validation of a handwriting scale


Locations

Country Name City State
France Fondation Ophtalmique Adolphe de Rothschild Paris

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary hand-writing speed speed and accuracy of handwriting immediate
See also
  Status Clinical Trial Phase
Completed NCT00006336 - Sensory Training to Treat Focal Dystonia N/A
Completed NCT03797638 - Characterization of Manual Dexterity by Finger Force Manipuladum (FFM) in Patients With Writer's Cramp and in Control Subjects N/A
Completed NCT00017875 - Transcranial Magnetic Stimulation (TMS) Studies of Dystonia N/A
Completed NCT03232320 - Meditoxin® Treatment in Patients With Cervical Dystonia Phase 3