Apathy in Tourette Syndrome and Changes in Quality of Life

NCT ID: NCT02765178

Last Updated: 2017-07-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-04-30

Brief 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. 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.

Conditions

Tourette Syndrome; Apathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Children's Motivation Scale

Intervention Type: OTHER

A 16-item questionnaire to evaluate level of motivation in children and adolescents completed by the primary caregiver.

Yale Global Tic Severity Scale (YGTSS)

Intervention Type: 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)

Intervention Type: 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 scale

Intervention Type: OTHER

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 Data

Intervention Type: OTHER

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.

Children's Motivation Scale

Intervention Type: OTHER

A 16-item questionnaire to evaluate level of motivation in children and adolescents completed by the primary caregiver.

Interventions

Children's Motivation Scale

A 16-item questionnaire to evaluate level of motivation in children and adolescents completed by the primary caregiver.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• History of cerebral palsy or traumatic brain injury

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wissam Deeb

Role: PRINCIPAL_INVESTIGATOR

UF Center for Movement Disorders and Neurorestoration

Locations

UF Center for Movement Disorders and Neurorestoration

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201500989

Identifier Type: -

Identifier Source: org_study_id