Apathy in Tourette Syndrome and Changes in Quality of Life

July 3, 2017 updated by: University of Florida

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32607
        • UF Center for Movement Disorders and Neurorestoration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Diagnosis: Tourette syndrome
  • Age: 12-16 years
  • Followed at the CMDNR

Exclusion Criteria:

  • History of cerebral palsy or traumatic brain injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Children's Motivation Scale
A 16-item questionnaire to evaluate level of motivation in children and adolescents completed by the primary caregiver.
Other: 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: 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: 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).
Other: Demographic Data
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).
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.
Other: Children's Motivation Scale
A 16-item questionnaire to evaluate level of motivation in children and adolescents completed by the primary caregiver.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Yale Global Tic Severity Scale (YGTSS)
Time Frame: Day 1
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.
Day 1
Studies Depression Scale for Children (CES-DC)
Time Frame: Day 1
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
Day 1
Gilles de la Tourette Syndrome Quality Of Life scale
Time Frame: Day 1
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).
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wissam Deeb, UF Center for Movement Disorders and Neurorestoration

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB201500989

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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