Tourette SyndromeNCT02765178
Apathy in Tourette Syndrome and Changes in Quality of Life
An observational study of Tourette Syndrome and Apathy, run by University of Florida at 1 site in United States.
Trial summary
Tourette syndrome is a complex neuropsychological disorder with both motor and vocal tics associated with multiple psychological co-morbidities. Apathy has not been widely studied in patients with Tourette syndrome. Apathy can result in decrease in self-care and disease control. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Tourette Syndrome, Apathy
- What is being tested?
- Children's Motivation Scale, Yale Global Tic Severity Scale (YGTSS) and Studies Depression Scale for Children (CES-DC)
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Targeted study population includes patients 12-16 years old diagnosed with Tourette Syndrome who are a patient of University of Florida Movement Disorders Center.
Who may be able to join
- Diagnosis: Tourette syndrome
- Age: 12-16 years
- Followed at the CMDNR
Who cannot join
- History of cerebral palsy or traumatic brain injury
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32607
About this study
Official title: Apathy in Tourette Syndrome and Changes in Quality of Life - Effect of Medications
Tourette syndrome is a complex neuropsychological disorder with both motor and vocal tics associated with multiple psychological co-morbidities. Apathy has not been widely studied in patients with Tourette syndrome. Apathy can result in decrease in self-care and disease control. In this study investigators will compare the occurrence of apathy in the adolescent Tourette syndrome population (at the UF center for movement disorders and Neurorestoration) to an age and gender matched control population. Investigators will also assess the role of commonly used medications in the Tourette population (neuroleptics and selective serotonin receptor inhibitors) in the occurrence of apathy.
Read the detailed description
Tourette syndrome(TS) is a complex neuropsychological disorder with both motor and vocal tics associated with multiple psychological co-morbidities. The most common co-morbidities include obsessive compulsive disorder (OCD), attention deficit and hyperactivity disorder (ADHD) and depression. Apathy has not been extensively studied in the Tourette syndrome population. Apathy is currently defined as reduced motivation, with symptoms in at least two of three domains of reduced initiative, reduced interest and/or reduced emotional responsiveness. A study assessed the prevalence of apathy in multiple movement disorders and reported that apathy is much more common in disorders associated with slowed movements like Parkinson disease while less common in disorders with increased movements like Huntington disease and Tourette syndrome in adults. However, no apathy studies in adolescent patients with Tourette syndrome are published. Disengagement from treatment may affect health outcomes in other disease states. Apathy has significant effects on the quality of life and health outcomes in many patients. Apathy can be a direct manifestation of the neuropsychological process (intrinsic to the disease) or can be secondary to medication side effects most notably anti-dopaminergic agents and some reports of selective serotonin receptor inhibitors (SSRI). Further attention to the prevalence and impact of apathy in the adolescent Tourette syndrome population is needed to explore if this may be a factor influencing TS management and ultimately Quality of life (QOL). Multiple psychotropic medications are used in the management of tics as well as the psychological co-morbidities. How these medications affect apathy prevalence in Tourette syndrome patients is not known.
- Conditions
- Tourette Syndrome, Apathy
- Being tested
- Children's Motivation Scale, Yale Global Tic Severity Scale (YGTSS), Studies Depression Scale for Children (CES-DC), Gilles de la Tourette Syndrome Quality Of Life scale, Demographic Data
- Medical subject headings
- Tourette Syndrome, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Children's Motivation ScaleOther
A 16-item questionnaire to evaluate level of motivation in children and adolescents completed by the primary caregiver.
Yale Global Tic Severity Scale (YGTSS)Other
Clinician administered questionnaire given to Tourette patients. Part 1 asks about 10 types of motor tics, 12 types of vocal tics (current, ever, age of onset, description). Part 2 is a severity rating that scores both motor and vocal tics on a 0-5 scale for each severity item: number of tics, intensity, frequency, complexity, interference, impairment. Totals are summed for all items.
Studies Depression Scale for Children (CES-DC)Other
Clinician administered questionnaire given to Tourette patients. Consisting of 20 items, respondents are asked to indicate how strongly they have felt a certain way during the past week using a Likert-type scale that ranges from "not at all" to "a lot." Only two items on the questionnaire relate specifically to sleep or fatigue. CES-DC is a validated score for assessing depression in children and adolescents
Gilles de la Tourette Syndrome Quality Of Life scaleOther
Clinician administered questionnaire given to Tourette patients. Gilles de la Tourette Syndrome Quality Of Life scale (GTS-QOL) is a recently validated score for the assessment of quality of life in patients with Tourette syndrome. Consisting of a 27-item GTS-specific HR-QOL scale (GTS-QOL) with four subscales (psychological, physical, obsessional, and cognitive).
Demographic DataOther
Data will be collected including: age, age at disease onset, gender, current medication regimen and presence of co-morbidities (like a diagnosis of ADHD, OCD, depression or insomnia).
| Study group | Role | What they receive |
|---|---|---|
| Patients with Tourette Syndrome | The primary caregiver will be asked to fill the Children's motivation Scale. Other measures will be collected including a clinician filled Yale Global Tic Severity Scale (YGTSS) - severity score, Center for Epidemiological Studies Depression Scale for Children (CES-DC) and Gilles de la Tourette Syndrome Quality Of Life scale (GTS-QOL). Demographic data will also be collected for each study patient. Demographic data will also be collected for each study patient. Receives: Other: Children's Motivation Scale; Other: Yale Global Tic Severity Scale (YGTSS); Other: Studies Depression Scale for Children (CES-DC); Other: Gilles de la Tourette Syndrome Quality Of Life scale; Other: Demographic Data | |
| Patients with Diabetes type 1 | The primary caregiver will be asked to fill the Children's motivation Scale. Demographic data will also be collected for each study patient. Receives: Other: Children's Motivation Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Motivation Scale
A 16-item questionnaire to evaluate level of motivation in children and adolescents completed by the primary caregiver.
Measured: Day 1
Secondary outcomes (3)
Yale Global Tic Severity Scale (YGTSS)
Clinician administered questionnaire given to Tourette patients. Part 1 asks about 10 types of motor tics, 12 types of vocal tics (current, ever, age of onset, description). Part 2 is a severity rating that scores both motor and vocal tics on a 0-5 scale for each severity item: number of tics, intensity, frequency, complexity, interference, impairment. Totals are summed for all items.
Measured: Day 1
Studies Depression Scale for Children (CES-DC)
Clinician administered questionnaire given to Tourette patients. Consisting of 20 items, respondents are asked to indicate how strongly they have felt a certain way during the past week using a Likert-type scale that ranges from "not at all" to "a lot." Only two items on the questionnaire relate specifically to sleep or fatigue. CES-DC is a validated score for assessing depression in children and adolescents
Measured: Day 1
Gilles de la Tourette Syndrome Quality Of Life scale
Clinician administered questionnaire given to Tourette patients. Gilles de la Tourette Syndrome Quality Of Life scale (GTS-QOL) is a recently validated score for the assessment of quality of life in patients with Tourette syndrome. Consisting of a 27-item GTS-specific HR-QOL scale (GTS-QOL) with four subscales (psychological, physical, obsessional, and cognitive).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2017
- Study completionApr 2017
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 of FloridaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wissam Deeb, Principal investigator, UF Center for Movement Disorders and Neurorestoration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765178
- Sponsor's protocol ID
- IRB201500989
- Status last verified
- Jul 2017
- First submitted
- 4 May 2016
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apathy in Tourette Syndrome and Changes in Quality of Life - Effect of Medications
- ClinicalTrials.gov ID
- NCT02765178
- Acronym / sponsor ID
- IRB201500989
- Conditions
- Tourette Syndrome, Apathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 6 May 2016 (estimated)
- 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.
Tourette syndrome is a complex neuropsychological disorder with both motor and vocal tics associated with multiple psychological co-morbidities. Apathy has not been widely studied in patients with Tourette syndrome. Apathy can result in decrease in self-care and disease control. In this study investigators will compare the occurrence of apathy in the adolescent Tourette syndrome population (at the UF center for movement disorders and Neurorestoration) to an age and gender matched control population. Investigators will also assess the role of commonly used medications in the Tourette population (neuroleptics and selective serotonin receptor inhibitors) in the occurrence of apathy.
Detailed description
Tourette syndrome(TS) is a complex neuropsychological disorder with both motor and vocal tics associated with multiple psychological co-morbidities. The most common co-morbidities include obsessive compulsive disorder (OCD), attention deficit and hyperactivity disorder (ADHD) and depression. Apathy has not been extensively studied in the Tourette syndrome population. Apathy is currently defined as reduced motivation, with symptoms in at least two of three domains of reduced initiative, reduced interest and/or reduced emotional responsiveness. A study assessed the prevalence of apathy in multiple movement disorders and reported that apathy is much more common in disorders associated with slowed movements like Parkinson disease while less common in disorders with increased movements like Huntington disease and Tourette syndrome in adults. However, no apathy studies in adolescent patients with Tourette syndrome are published. Disengagement from treatment may affect health outcomes in other disease states. Apathy has significant effects on the quality of life and health outcomes in many patients. Apathy can be a direct manifestation of the neuropsychological process (intrinsic to the disease) or can be secondary to medication side effects most notably anti-dopaminergic agents and some reports of selective serotonin receptor inhibitors (SSRI). Further attention to the prevalence and impact of apathy in the adolescent Tourette syndrome population is needed to explore if this may be a factor influencing TS management and ultimately Quality of life (QOL). Multiple psychotropic medications are used in the management of tics as well as the psychological co-morbidities. How these medications affect apathy prevalence in Tourette syndrome patients is not known.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Tourette Syndrome | – | Other: Children's Motivation Scale, Other: Yale Global Tic Severity Scale (YGTSS), Other: Studies Depression Scale for Children (CES-DC), Other: Gilles de la Tourette Syndrome Quality Of Life scale, Other: Demographic DataThe primary caregiver will be asked to fill the Children's motivation Scale. Other measures will be collected including a clinician filled Yale Global Tic Severity Scale (YGTSS) - severity score, Center for Epidemiological Studies Depression Scale for Children (CES-DC) and Gilles de la Tourette Syndrome Quality Of Life scale (GTS-QOL). Demographic data will also be collected for each study patient. Demographic data will also be collected for each study patient. |
| Patients with Diabetes type 1 | – | Other: Children's Motivation ScaleThe primary caregiver will be asked to fill the Children's motivation Scale. Demographic data will also be collected for each study patient. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Targeted study population includes patients 12-16 years old diagnosed with Tourette Syndrome who are a patient of University of Florida Movement Disorders Center.
Key inclusion criteria (3 listed)
- Diagnosis: Tourette syndrome
- Age: 12-16 years
- Followed at the CMDNR
Key exclusion criteria (1 listed)
- History of cerebral palsy or traumatic brain injury
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 |
|---|---|---|
| Children's Motivation ScaleA 16-item questionnaire to evaluate level of motivation in children and adolescents completed by the primary caregiver. | Other | Patients with Diabetes type 1, Patients with Tourette Syndrome |
| Yale Global Tic Severity Scale (YGTSS)Clinician administered questionnaire given to Tourette patients. Part 1 asks about 10 types of motor tics, 12 types of vocal tics (current, ever, age of onset, description). Part 2 is a severity rating that scores both motor and vocal tics on a 0-5 scale for each severity item: number of tics, intensity, frequency, complexity, interference, impairment. Totals are summed for all items. | Other | Patients with Tourette Syndrome |
| Studies Depression Scale for Children (CES-DC)Clinician administered questionnaire given to Tourette patients. Consisting of 20 items, respondents are asked to indicate how strongly they have felt a certain way during the past week using a Likert-type scale that ranges from "not at all" to "a lot." Only two items on the questionnaire relate specifically to sleep or fatigue. CES-DC is a validated score for assessing depression in children and adolescents | Other | Patients with Tourette Syndrome |
| Gilles de la Tourette Syndrome Quality Of Life scaleClinician administered questionnaire given to Tourette patients. Gilles de la Tourette Syndrome Quality Of Life scale (GTS-QOL) is a recently validated score for the assessment of quality of life in patients with Tourette syndrome. Consisting of a 27-item GTS-specific HR-QOL scale (GTS-QOL) with four subscales (psychological, physical, obsessional, and cognitive). | Other | Patients with Tourette Syndrome |
| Demographic DataData will be collected including: age, age at disease onset, gender, current medication regimen and presence of co-morbidities (like a diagnosis of ADHD, OCD, depression or insomnia). | Other | Patients with Tourette Syndrome |
Primary outcome
Children's Motivation Scale
Time frame: Day 1
A 16-item questionnaire to evaluate level of motivation in children and adolescents completed by the primary caregiver.
3 secondary outcomes
Yale Global Tic Severity Scale (YGTSS)
Time frame: Day 1
Studies Depression Scale for Children (CES-DC)
Time frame: Day 1
Gilles de la Tourette Syndrome Quality Of Life scale
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Tourette Syndrome
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Tourette Syndrome, Chronic Tic Disorder
Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease
Recruiting
Exploring the Role of Neuroactive Steroids in Tourette Syndrome
Tourette Syndrome in Children
Active, not recruiting
Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
Tourette Syndrome
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. This study is not recruiting at the moment.
Wissam Deeb principal investigator
UF Center for Movement Disorders and Neurorestoration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tourette Syndrome and Apathy, run by University of Florida at 1 site in United States.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 6 Jul 2017. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Motivation Scale (time frame: Day 1). 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 6 Jul 2017.