Tourette SyndromeAFFIRMATICSNCT06136572
Epidemiology of Assertiveness and Emotion Management Disorders in People With Tourette's Syndrome
A study testing Rathus Assertiveness scale in people with Tourette Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The goal of this study is to evaluate the proportion of assertiveness difficulties in Tourette syndrome. Participants will complete several e-questionnaires (on assertiveness, Tourette severity, quality of life, self-esteem and comorbidities like depression, anxiety...). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Rathus Assertiveness scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2024to 5 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tourette syndrome
- Participants aged 18 years or over
Who cannot join
- Participants under legal protection
- Inability to complete questionnaires alone
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, France
Lise Laclautre
About this study
The goal of this study is to evaluate the proportion of assertiveness difficulties in Tourette syndrome. Participants will complete several e-questionnaires (on assertiveness, Tourette severity, quality of life, self-esteem and comorbidities like depression, anxiety...).
- Conditions
- Tourette Syndrome
- Being tested
- Rathus Assertiveness scale
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rathus Assertiveness scaleDiagnostic test
Questionnaire completion
| Study group | Role | What they receive |
|---|---|---|
| Rathus Assertiveness scale | Experimental | All participants Receives: Diagnostic Test: Rathus Assertiveness scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rathus assertiveness questionnaire
The Rathus assertiveness questionnaire includes 30 items, each scores from -3 to +30. A total score inferior or equal to -9 reveals assertiveness difficulties.
Measured: 5 minutes at inclusion
Secondary outcomes (6)
MOVES
The MOVES is a self-questionnaire including 20 items which measures the severity of the Tourette syndrome. Several scores are defined : motor tics, vocal tics, obsession, compulsion and other phenomena. The higher the score, the greater the severity.
Measured: less than 5 minutes at inclusion
HADS
The HADS is a self-questionnaire to assess depression (7 items) and anxiety (7 items).
Measured: 3 minutes at inclusion
ASRS-5
The Adult AD-HD Self-Report Scale (ASRS-5) is a scale to assess the presence of Attention-Deficit / Hyperactivity Disorder. We used the first 6 items of the questionnaire for the screening of ADHD. The total score ranges from 0 to 24 and a cut off of 13 shows good screening performance.
Measured: 2 minutes at inclusion
Rosenberg Self-Esteem Scale
The Rosenberg Self-Esteem Scale is a self-questionnaire on self-esteem. It includes 10 items. The lower the score, the lower the self-esteem.
Measured: 2-3 minutes at inclusion
DERS
The Difficulties in Emotion Regulation Scale (DERS) is a self-questionnaire including 36 items. Lower scores indicate the presence of difficulties in emotion regulation.
Measured: 5 minutes at inclusion
GTS-QoL
The GTS-QoL is a specific Gilles de la Tourette Syndrome Quality of Life Scale. It consists of 27 items giving 6 dimensions: "Psychological", "Physical and activities of daily life", "Obsessive-compulsive", "Cognitive", "Social" and "Echo-coprophenomena", scored out of 100. The scores the highest represent a poorer quality of life.
Measured: 5 minutes at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start6 May 2024
- Primary completion5 May 2026 (estimated)
- Study completion5 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle JALENQUES, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136572
- Sponsor's protocol ID
- RNI 2023 JALENQUES
- Acronym
- AFFIRMATICS
- Status last verified
- Feb 2026
- First submitted
- 13 Nov 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Assertiveness and Emotion Management Disorders in People With Tourette's Syndrome
- ClinicalTrials.gov ID
- NCT06136572
- Acronym / sponsor ID
- AFFIRMATICS / RNI 2023 JALENQUES
- Conditions
- Tourette Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 5 Nov 2026 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the proportion of assertiveness difficulties in Tourette syndrome. Participants will complete several e-questionnaires (on assertiveness, Tourette severity, quality of life, self-esteem and comorbidities like depression, anxiety...).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rathus Assertiveness scale | Experimental | Diagnostic Test: Rathus Assertiveness scaleAll participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Tourette syndrome
- Participants aged 18 years or over
Key exclusion criteria (2 listed)
- Participants under legal protection
- Inability to complete questionnaires alone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rathus Assertiveness scaleQuestionnaire completion | Diagnostic test | Rathus Assertiveness scale |
Primary outcome
Rathus assertiveness questionnaire
Time frame: 5 minutes at inclusion
The Rathus assertiveness questionnaire includes 30 items, each scores from -3 to +30. A total score inferior or equal to -9 reveals assertiveness difficulties.
6 secondary outcomes
MOVES
Time frame: less than 5 minutes at inclusion
HADS
Time frame: 3 minutes at inclusion
ASRS-5
Time frame: 2 minutes at inclusion
Rosenberg Self-Esteem Scale
Time frame: 2-3 minutes at inclusion
DERS
Time frame: 5 minutes at inclusion
GTS-QoL
Time frame: 5 minutes at inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Tourette Syndrome
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Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
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Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease
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Exploring the Role of Neuroactive Steroids in Tourette Syndrome
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Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle JALENQUES principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rathus Assertiveness scale in people with Tourette Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rathus assertiveness questionnaire (time frame: 5 minutes at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.