NCT03797638

Brief Summary

Writer's cramp is a focal dystonia characterized by abnormal movements and postures during writing. Limited finger independence during writing manifests as difficulty suppressing unwanted activations of neighbouring non task-relevant fingers. Patients with Writer's cramp also have difficulty in fine control of grip force. The investigators have recently developed the Finger Force Manipulandum which quantifies the forces applied by each fingers in different tasks. This method is sensitive for detection and quantification of small unwanted contractions in non-active ('stationary') fingers. Different tasks have been developed to assess abilities such as finger individuation but also fine finger force control, finger movement regularity and speed. The aim of this study is to assess if developed tasks allow to precisely characterize writer's cramp condition in terms of abilities aforementioned. To do so, performance of 20 writer's cramp patients in the developed task will be compared with performance of 20 control participants (matched in age, sex and writing hand) in the same tasks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2019

Completed
Last Updated

June 22, 2021

Status Verified

June 1, 2021

Enrollment Period

10 months

First QC Date

January 7, 2019

Last Update Submit

June 20, 2021

Conditions

Dystonic DisorderFocal DystoniaWriter's Cramp

Keywords

Dystonic DisorderFocal DystoniaWriter's Cramp

Outcome Measures

Primary Outcomes (1)

  • Manual dexterity by the FFM

    Compare the manual dexterity by the FFM between subjects with writer's cramp and control subject

    Inclusion

Study Arms (2)

Patients with writer's cramp

EXPERIMENTAL

Patients with writer's cramp

Device: Finger Force Manipuladum (FFM)

Control subjects

OTHER

Control subjects, without writer's cramp, matched with case subjects with age, gender and hand writing

Device: Finger Force Manipuladum (FFM)

Interventions

Finger Force Manipuladum (FFM)DEVICE

Tasks performed with the device Finger Force Manipuladum (FFM), to assess abilities such as finger individuation but also fine finger force control, finger movement regularity and speed.

Control subjectsPatients with writer's cramp

Eligibility Criteria

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

You may qualify if:

  • Patient with writer's cramp and writing speed \<140 letters / min
  • Writer's cramp focal dystonia specific to the task of writing
  • Patient treated or not with botulinum toxin injection
  • Person having attended school in French
  • Patients whose writer's cramp has no impact on the handwriting and has kept a writing speed\> 140 letters per minute.
  • Tremor of writing
  • Neurological condition other than writer's cramp (eg Parkinson's syndrome)
  • Pain, trauma or pathology of the upper limb of the writing member other than the writer's cramp who required medical or surgical treatment in the last 6 months preceding the initial check-up
  • \> 18 years old
  • Without writer's cramp
  • Person having attended school in French
  • Tremor of writing
  • Neurological condition other than writer's cramp (eg Parkinson's syndrome)
  • Pain, trauma or pathology of the upper limb of the writing member other than the writer's cramp who required medical or surgical treatment in the last 6 months preceding the initial check-up
  • Matching criteria between cases and control patients
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation A de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Dystonic Disorders

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jean-Pierre BLETON, PhD

    Fondation A. de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 9, 2019

Study Start

October 1, 2018

Primary Completion

July 19, 2019

Study Completion

July 19, 2019

Last Updated

June 22, 2021

Record last verified: 2021-06

Locations

FR(1)