Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576726
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Sensorimotor and Psychosocial Trajectories in Adolescents with Tic Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sensorimotor and Psychosocial Trajectories in Adolescents with Tic Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Individuals with tic disorders have lower quality of life sensory and movement difficulties and poorer mental social and physical health compared to the general population Current clinical care for individuals with tic disorders is limited no interventions are proven to prevent or stop the disorder exist and most treatments focus solely on tics though other symptoms often affect quality of life more than tics To develop new treatments and improve care for people with tics researchers need to better understand the different symptoms people experience and how the brain causes these symptoms
Many individuals with tic disorders have sensory and movement symptoms other than tics A common sensory symptom is increased sensitivity to common sensations such as glare from sunlight tags in shirt collars and noises from passing cars A common movement symptom is poor handwriting andor poor coordination In one study of adolescents with tic disorder difficulty with hand coordination predicted tic severity 75 years later suggesting that sensory andor motor difficulties may be a risk factor for more severe tics later in life Despite how common they are much is unknown about sensory and motor difficulties experienced by people with tic disorders
Additionally most studies of people with tics enroll younger children As a result little is known about sensory motor and psychosocial development in adolescents with tics Knowledge of sensory and motor difficulties in adolescents with tics is important to understand because in other adolescent populations such difficulties are associated with worse mental and social health and worse quality of life Deepening insight into the sensory motor and psychosocial development of adolescents with tic disorders is crucial to identify causes and risk factors for poor health in this population
The goals of this study are to measure sensory and motor symptoms and function in adolescents with tics and to compare them to adolescents without tics The research team will enroll adolescents with tics and adolescents without tics to participate in the study Adolescent participants will complete questionnaires electroencephalogram EEG tasks and other sensory and motor tasks at baseline with 2 study visits occurring within 30 days of each other and 2 years later again with 2 study visits occurring within 30 days of each other A parent or other adult who knows the adolescent well will also complete questionnaires as part of the study
Many individuals with tic disorders have sensory and movement symptoms other than tics A common sensory symptom is increased sensitivity to common sensations such as glare from sunlight tags in shirt collars and noises from passing cars A common movement symptom is poor handwriting andor poor coordination In one study of adolescents with tic disorder difficulty with hand coordination predicted tic severity 75 years later suggesting that sensory andor motor difficulties may be a risk factor for more severe tics later in life Despite how common they are much is unknown about sensory and motor difficulties experienced by people with tic disorders
Additionally most studies of people with tics enroll younger children As a result little is known about sensory motor and psychosocial development in adolescents with tics Knowledge of sensory and motor difficulties in adolescents with tics is important to understand because in other adolescent populations such difficulties are associated with worse mental and social health and worse quality of life Deepening insight into the sensory motor and psychosocial development of adolescents with tic disorders is crucial to identify causes and risk factors for poor health in this population
The goals of this study are to measure sensory and motor symptoms and function in adolescents with tics and to compare them to adolescents without tics The research team will enroll adolescents with tics and adolescents without tics to participate in the study Adolescent participants will complete questionnaires electroencephalogram EEG tasks and other sensory and motor tasks at baseline with 2 study visits occurring within 30 days of each other and 2 years later again with 2 study visits occurring within 30 days of each other A parent or other adult who knows the adolescent well will also complete questionnaires as part of the study
Detailed Description:
The study consists of 4 visits over the course of 2 years The first 2 visits will occur within 30 days of each other and then two years later participants will be asked to attend two more study visits again within 30 days of each other
Study Visit 1 can occur in-person or remotely If you and your adolescent prefer the remote visit this will be conducted over Zoom Microsoft Teams or another commercial audiovisual platform During Visit 1 adolescents will be interviewed by a trained rater to assess for tics obsessive-compulsive disorder OCD and attention-deficithyperactivity disorder ADHD The interview will take about 1 hour Adolescents will then be asked to complete a series of online questionnaires asking about sensory experiences coordination puberty mental health and social health The questionnaires will take about 15 hours to complete In total Visit 1 will take about 2 hours and 30 minutes
Study Visit 2 will occur in-person within 30 days of Visit 1 During Visit 2 adolescents will complete questionnaires about sensory experiences stress and other symptoms of tic disorders Questionnaires will take about 1 hour to complete Then adolescents39 motor coordination handwriting and intelligence will be assessed using various tasks and scales This will take about 2 hours and 30 minutes Additionally adolescents39 height weight and waste circumference will be measured At the end of the visit adolescents who are eligible will have an electroencephalogram EEG during which their brain activity will be measured while they experience different sensory stimuli such as puffs of air simple sounds and perform different simple motor tasks such as tapping The EEG tasks will take about 1 hour and 30 minutes In total Visit 2 will take about 5 hours for adolescents eligible for EEG procedures Visit 2 will take about 3 hours and 30 minutes for adolescents not eligible for EEG procedures While the adolescent is being assessed a parent or other adult caregiver will complete questionnaires about the adolescent and themselves these questionnaires which take a total of 2 hours to complete ask about mental health social health and quality of life
Study Visit 3 will occur 2 years after Study Visit 1 Visit 3 can occur in-person or remotely Visit 3 procedures are identical to Visit 1 procedures
Study Visit 4 will occur in-person within 30 days of Visit 3 Visit 4 procedures are identical to Visit 2 procedures
Study Visit 1 can occur in-person or remotely If you and your adolescent prefer the remote visit this will be conducted over Zoom Microsoft Teams or another commercial audiovisual platform During Visit 1 adolescents will be interviewed by a trained rater to assess for tics obsessive-compulsive disorder OCD and attention-deficithyperactivity disorder ADHD The interview will take about 1 hour Adolescents will then be asked to complete a series of online questionnaires asking about sensory experiences coordination puberty mental health and social health The questionnaires will take about 15 hours to complete In total Visit 1 will take about 2 hours and 30 minutes
Study Visit 2 will occur in-person within 30 days of Visit 1 During Visit 2 adolescents will complete questionnaires about sensory experiences stress and other symptoms of tic disorders Questionnaires will take about 1 hour to complete Then adolescents39 motor coordination handwriting and intelligence will be assessed using various tasks and scales This will take about 2 hours and 30 minutes Additionally adolescents39 height weight and waste circumference will be measured At the end of the visit adolescents who are eligible will have an electroencephalogram EEG during which their brain activity will be measured while they experience different sensory stimuli such as puffs of air simple sounds and perform different simple motor tasks such as tapping The EEG tasks will take about 1 hour and 30 minutes In total Visit 2 will take about 5 hours for adolescents eligible for EEG procedures Visit 2 will take about 3 hours and 30 minutes for adolescents not eligible for EEG procedures While the adolescent is being assessed a parent or other adult caregiver will complete questionnaires about the adolescent and themselves these questionnaires which take a total of 2 hours to complete ask about mental health social health and quality of life
Study Visit 3 will occur 2 years after Study Visit 1 Visit 3 can occur in-person or remotely Visit 3 procedures are identical to Visit 1 procedures
Study Visit 4 will occur in-person within 30 days of Visit 3 Visit 4 procedures are identical to Visit 2 procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None