NCT05090943

Brief Summary

The purpose of this study is to develop the adult tic disorders registry in order to characterize the relationship between tic severity and tic-related impairment in women compared to men with tic disorders.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Dec 2021

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
recruiting

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 Progress78%
Dec 2021Dec 2027

First Submitted

Initial submission to the registry

September 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

6 years

First QC Date

September 22, 2021

Last Update Submit

August 27, 2025

Conditions

Tic Disorders

Outcome Measures

Primary Outcomes (1)

  • Correlation between Quality of Life and TICs severity

    Severity of the tics measurement (YGTSS Impairment Score) and the quality of life (TS-QOL) between men and women with tic disorders, while controlling for the YGTSS Total Tic Score

    6 months

Secondary Outcomes (1)

  • Change in TICs

    6 months

Study Arms (1)

Quality of life questionnaires

Other: QOL to be completed by the participant

Interventions

QOL to be completed by the participantOTHER

The scales (PUTS, OCI, TS-QOL, ASRS, GAD-7, PHQ9, TAPS) to be completed by the participant

Quality of life questionnaires

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with tics disorders

You may qualify if:

  • Age \>18 years
  • Patients with Tic disorders
  • Given the non-opposition
  • No affiliation to a French health social insurance
  • Significant congenital disorders that may affect understanding of assessments
  • Patients under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

CHU Limoges

Limoges, 87042, France

RECRUITING

CHU Marseille

Marseille, 13003, France

RECRUITING

Service de Neurologie, GH Pitié Salpêtrière

Paris, 75013, France

RECRUITING

CHU Poitiers

Poitiers, 86000, France

RECRUITING

CHU Nantes

Saint-Herblain, 44800, France

RECRUITING

CHU Strasbourg

Strasbourg, 67200, France

RECRUITING

MeSH Terms

Conditions

Tic Disorders

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Emmanuel Flamand-Roze, MD, PhD

CONTACT

1 42 16 06 45emmanuel.flamand-roze@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2021

First Posted

October 25, 2021

Study Start

December 1, 2021

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

September 4, 2025

Record last verified: 2025-08

Locations

FR(7)