95 Clinical Trials for Various Conditions
The primary aim of this study is to learn more about premonitory urges (PU) when using Habit Reversal Training (HRT) to treat tics. The main focus of this study is to investigate if and when PU change during tic treatment sessions and between tic treatment sessions. Participants will: * Attend 5 study visits (approximately 1 to 1.5 hours each) for an intake, habit reversal training for 3 separate tics, and a post assessment * Attend 5 practice sessions (approximately 30 minutes each) over a week for 3 weeks (total 15 practice sessions) * Study visits and practice sessions will take place in person and online via secure videoconference
The goal of this clinical study is to learn more about the timing of tics (sudden, fast movements and sounds that people do and make without meaning to) in people who have multiple tics that have been going on for more than one year. The main questions it aims to answer are: 1. See whether a tic's timing is related to other characteristics of the tic, like how long it has been happening and how well the person can control/stop that tic 2. See whether the timing of a tic can tell us how well the person can control/stop that tic 3. See whether tic treatment changes the timing of tics, and if the timing of a tic has anything to do with how well treatment will work to stop it Participants will meet with a study researcher to learn more about the study, ask questions, and decide whether or not they would like to be involved. If they decide to do the study, they will meet with the researcher 6 times: 1. During the first visit, the study researcher will ask questions about the participant's life, tics, and other psychological symptoms. The researcher will watch the participant's tics for 10 minutes. The participant will do a computer task where they follow instructions to tic or not tic. 2. During the second visit, the study researcher will treat one of the participant's tics. 3. During the third visit, the study researcher will treat another one of the participant's tics. 4. During the fourth visit, the study researcher will treat another one of the participant's tics. 5. During the fifth visit, the study researcher will treat another one of the participant's tics. 6. During the sixth visit, the study researcher will ask questions about the participant's tics and other psychological symptoms. The participant will do a computer task where they follow instructions to tic or not tic.
Tic disorders are a class of childhood-onset neuropsychiatric disorders that occur in 1-3% of the population. Studies have shown that a non-drug treatment known as Comprehensive Behavioral Intervention for Tics (CBIT) is more effective than supportive therapy for reducing tics in children and adults. Although CBIT is now recommended as a first-line intervention for tic disorders, many patients do not have access to CBIT, in part due to a lack of trained therapists. Currently, the only option available for training therapists in CBIT is an intensive, two day, in-person behavior therapy training institute (BTTI). This study will compare the traditional in-person training approach to a recently developed online, self-paced CBIT therapist training program called CBIT-Trainer with regard to (1) therapists' ability to accurately administer CBIT and (2) change in the severity of patients' tic symptoms after being treated by a CBIT-trained therapist.
The purpose of this pilot trial is to examine the preliminary efficacy of online-delivered Comprehensive Behavioral Intervention for Tics - Enhanced (CBIT-E). In the study, 30 children with persistent tic disorders (PTDs) will be recruited via information provided to patients of the Marquette University (MU) Tic Disorders Specialty Clinic (TDSC) and information conveyed via local medical health professionals, with the goal of randomizing 10 participants to each group. For those randomized to CBIT-E, treatment will be administered according to the standard CBIT manual, but there will be two modifications. CBIT typically consists of the implementation of strategies to help manage the environment related to tics and the implementation of an exercise to engage in when an individual feels the urge to tic. CBIT-E will include these same techniques, plus additional in-session and out of session practice of the exercises, called competing responses, that individuals use when they feel the urge to tic. Treatment will be delivered over Microsoft Teams, which is a secure video conferencing system. The therapist will administer treatment from a private room in the Marquette University Tic Disorder Specialty Clinic, while the parent and child will be at their home. Treatment will include a screening visit, baseline assessment, 11 weeks (9 sessions) of CBIT-E, a post treatment assessment, and a three-month follow up assessment. Further, starting after session 3, there will be four 15-minute practice periods scheduled each week between sessions. During these practice periods, the child and therapist will meet over Microsoft Teams and the therapist will administer an enhanced reward task. Children randomized to the waitlist control (WLC) will not receive treatment during the 11-week period. Instead, they will be placed on a waitlist to receive standard CBIT following the end of the study period. Participants in this group will complete a screening visit, baseline assessment, and a final assessment, which will occur approximately 11 weeks after baseline.
The study will examine whether combining Comprehensive Behavioral Intervention for Tics (CBIT) with inhibition of the supplementary motor area (SMA) using transcranial magnetic stimulation (TMS) normalizes activity in the SMA-connected circuits, improves tic suppression ability, and enhances CBIT outcomes in young people with tic disorder. The study will also examine different TMS dosing strategies.
This study examines circadian rhythms and morningness-eveningness preference in youth with Persistent Tic Disorders (PTDs), including Tourette's Disorder (TD); and assesses the effects of wearable short wavelength light therapy on circadian rhythms and tic symptoms.
The goal of this pilot study is to obtain preliminary information on the tolerability and efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette Disorder (TD, also called Tourette syndrome).
Doctors provide a ray of hope to children and their parents with the knowledge that, for most patients, symptoms of Tourette syndrome improve by the time they are young adults. The investigators do not know why some improve and others do not. This study is designed to help answer that question. The investigators will use magnetic resonance imaging (MRI) techniques to test whether individuals who experience improvement of their Tourette's (tic remission) have more mature brain connections than those who do not.
Specific Aim1: Using a paradigm of Transcranial Magnetic Stimulation called Continuous Theta Burst Stimulation (cTBS) to reduce tics in Tourette Syndrome subjects Hypothesis1: cTBS, compared to sham stimulation, will reduce tic severity by at least 25% as measured by the Yale Global Tic Severity Scale Specific Aim2: Using cTBS to further understand neural correlates of tic generation Hypothesis2: Functional MRI BOLD signal activation pattern will change after cTBS and this change will correlate with clinical improvement in tic severity
The study aims to clarify the functional anatomy of key brain circuits associated with cognitive control in children and adolescents with chronic tic disorders (CTD) and to compare and contrast hypothesized mechanisms related to increased tic control associated with Habit Reversal Training, a behavioral treatment that been previously shown to be effective in treating CTD. We also seek to better understand the relationship between fMRI and quantitative EEG in relevant brain circuits with the hope of establishing EEG as a valid and cost-effective marker of treatment responsiveness. A total of 25 subjects will be randomized to 10 weeks of Habit Reversal Training (HRT), a behavioral treatment, and 25 to 10 weeks of minimal-contact waitlist. Treatment responders will be re-assessed at three months. Waitlist nonresponders will be provided with 10 weeks of HRT. Study assessments, including a neurocognitive battery and quantitative EEG will be administered at baseline, Wk 5, Wk 10, and 3-month follow-up. Neuroimaging (fMRI) will be conducted at baseline and Wk 10.
The goal of this study is to confirm that levetiracetam has a better tic-suppressing profile than that of the widely used tic-suppressing medication, clonidine. More specifically, the investigators hypothesize that in a 15 week placebo run-in, double-blind, medication cross-over trial; levetiracetam will be more effective and have fewer side-effects than clonidine.
The purpose of this study is to determine the safety, tolerability and efficacy of galantamine in tic disorders. The impact of galantamine on commonly associated behaviors (i.e. attention, obsessions, etc.) will also be examined.
This study will examine brain activity associated with the involuntary urges or uncontrolled movements, called "tics," experienced by people who have Tourette syndrome (TS). Before people with TS actually develop a tic, whether it is a movement or a vocal tic (like a cough or bark), they feel the urge to tic. This study will look at brain activity during the time of this urge and how brain activity may differ in people with TS and without TS. Healthy normal volunteers and patients with TS between 14 and 65 years of age may be eligible for this study. Patients must have sensory tics in the facial region and must experience at least a moderate premonitory urge. Candidates are screened with a medical history, brief physical examination, and a questionnaire. Participants undergo the following procedures: * Magnetoencephalography (MEG): This test records magnetic field changes produced by brain activity. During the test, the subjects are seated in the MEG recording room and a cone containing magnetic field detectors is lowered onto their head. Electrodes (small metal disks) are placed on both sides of the face near the jaw. The recording may be made while the subject receives small currents from the electrodes on the jaw. Subjects may be asked a few questions about what they felt during the procedure. * Magnetic resonance imaging (MRI): This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. During the procedure, the subject lies on a table that can slide in and out of the scanner-a metal cylinder. Subjects may be asked to lie still for up to 30 minutes at a time. They can communicate with the staff at any time during the scan. * Somatosensory evoked responses: This test examines how sensory information travels form the nerves to the spinal cord and brain in the nervous system. An electrode placed on the arm, leg, or face delivers a small electrical stimulus that may tingle and cause a twitch of a hand, foot, or face muscle. Additional electrodes may sometimes be placed on the scalp, neck, and over the collarbone to record how the impulse from the stimulus travels over nerve pathways. Patients in the study are contacted for follow-up after the study. Follow-up will be conducted by phone or email, according to the patients' convenience, and will consist of reaffirming that there were no adverse events.
This study will investigate how the brain generates tics in patients with Tourette's syndrome and which areas of the brain are primarily affected. Tourette's syndrome is a neuropsychiatric disorder characterized by motor and vocal tics, and is associated with behavioral and emotional disturbances, including symptoms of attention deficit hyperactivity disorder and obsessive-compulsive disorder. This study will examine whether tic generation is related to changes in brain cell receptors for a chemical messenger called gamma-aminobutyric acid (GABA). Healthy normal volunteers and patients with Tourette's syndrome between 21 and 65 years of age may be eligible for this study. Candidates will be screened with a medical history and physical and neurological examinations. Participants will undergo positron emission tomography (PET) scanning to measure brain blood flow. For this procedure, the subject receives an injection of H215O, a radioactive substance similar to water. A special camera detects the radiation emitted by the H215O, allowing measurement of the blood flow. Subjects will receive up to five injections of H215O during the scanning. They will also be injected with another radioactive chemical, (11C) flumazenil, which binds to GABA receptors, to measure the density and distribution of these receptors. This will reveal which areas of the brain in patients with Tourette's syndrome have abnormal binding of flumazenil compared with the brains of healthy control subjects. During the PET procedure, the subject lies on a table in the PET scanner. A small catheter (plastic tube) is placed in an arm vein for injecting the radioactive tracers, and a mask is placed on the face to help keep the head still during scanning. The mask has large openings for eyes, nose and mouth, so that it does not interfere with talking or breathing. The entire test takes about 3 hours. On a separate day, participants will also undergo magnetic resonance imaging (MRI), a diagnostic test that uses a magnetic field and radio waves to produce images of the brain. For this procedure, the subject lies still on a stretcher that is moved into the scanner (a narrow cylinder containing the magnet). Earplugs are worn to muffle loud noises caused by electrical switching of radio frequency circuits used in the scanning process. The scan lasts about 45 to 60 minutes. ...
This study will investigate which areas of the brain are primarily involved in and responsible for tics in patients with Tourette's syndrome and chronic motor disorder. Tourette's syndrome is a neuropsychiatric disorder characterized by motor and vocal tics and is associated with behavioral and emotional disturbances, including symptoms of attention deficit hyperactivity disorder and obsessive-compulsive disorder. Chronic motor disorder has the same characteristics as Tourette's syndrome, except that patients do not have vocal tics. Healthy normal volunteers and patients with Tourette's syndrome or chronic motor tic disorder between 18 and 65 years of age may be eligible for this study. Candidates will be screened with a medical history and physical and neurological examinations. Participants will undergo positron emission tomography (PET) scanning to study tics under three conditions- spontaneous tics, suppression of tics, and sleep-to determine which areas of the brain are responsible for generation of tics. For this procedure, the subject is injected with H215O, a radioactive substance similar to water. A special camera detects the radiation emitted by the H215O, allowing measurement of brain blood flow. Subjects will receive up to 20 injections of H215O during the scanning. Participants will be asked not to sleep the entire night before the test. Before the scan, both patients and volunteers will have EEG electrodes placed on their heads to record the electrical activity of their brains. Patients will also have EMG electrodes placed in areas of the body where tics occur. A small catheter (plastic tube) will be placed in an arm vein for injecting the radioactive tracers, and a mask will be placed on the face to help keep the head still during scanning. The mask has large openings for eyes, nose and mouth, so that it does not interfere with talking or breathing. The entire test takes about 4 hours. During this time, the subject will sleep for 1.5 hours either at the beginning or end of the scan. For the other 2.5 hours, scans will be done every 10 minutes for 1 minute under the different conditions of tic suppression or release of tics. On a separate day, participants will also undergo magnetic resonance imaging (MRI), a diagnostic test that uses a magnetic field and radio waves to produce images of the brain. For this procedure, the subject lies still on a stretcher that is moved into the scanner (a narrow cylinder containing the magnet). ...
This study will investigate the brain areas that are activated by vocal and motor tics in patients with Tourette's syndrome and other tic disorders. Tics are involuntary repetitive movements similar to voluntary movements. They may be simple, involving only a few muscles or simple sounds, or complex, involving several groups of muscles in orchestrated bouts. This study will involve only simple motor tics, such as eye blinking, nose wrinkling, facial grimacing and abdominal tensing, and simple vocal tics, such as throat clearing, sniffing and snorting. Healthy normal volunteers and patients between 14 and 65 years of age with simple motor or vocal tics may be eligible for this study. Participants will have a brief medical history and physical examination and magnetic resonance imaging (MRI) of the brain. MRI uses a magnetic field and radio waves to produce images. For the procedure, the subject lies on a table that is moved into a cylindrical chamber containing a strong magnet. Earplugs are worn to muffle the loud thumping sounds made by electrical switching of the radio frequency circuits and protect against temporary hearing impairment. During the scan, normal volunteers will be asked to make simple movements or sounds designed to imitate tics, such as raising eyebrows, blinking or coughing. Patients with tic disorders will have two parts to the scanning session. First they will relax and allow tics to occur spontaneously, then they will be asked to imitate a specific tic when there is no urge to tic. Patients and healthy subjects will have electromyography (EMG) to record the timing of the voluntary movements and tics. For this procedure, several pairs of small, saucer-like electrodes are attached to the skin with a gel or paste. Electric signals from the electrodes are amplified and recorded on a computer. A microphone may be placed near patients to record any vocal tics. A video camera may also be used to record the tics.
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 and/or poor coordination. In one study of adolescents with tic disorder, difficulty with hand coordination predicted tic severity 7.5 years later, suggesting that sensory and/or 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.
This research study is being done to compare a mindfulness-based intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) for individuals with Tourette's syndrome or Persistent Tic Disorders (collectively TS). It is the investigator's hope that this information cam be used to improve current treatments for individuals with TS.
Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. Chronic tics are the primary symptom of Tourette Syndrome (TS) and Persistent Motor/Vocal Tic Disorders. CBIT is a manualized treatment focused on increasing tic controllability. Its core procedure is competing response training (CRT), in which patients learn to inhibit tics by learning and applying a competing motor action to one tic at a time. CBIT is recommended as a first-line treatment relative to medications and other therapies. However, only 52% of children and 38% of adults show clinically meaningful tic improvement. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients, and meta-analysis shows comparable effect sizes for CBIT and medication. Although increasing tic controllability is the primary goal of CBIT, tic controllability nor its correlates have been examined longitudinally during the intervention. The overall objective of this study is to use fine-grained data collection strategies to identify patterns in tic controllability and other relevant related variables that are associated with treatment response to CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded.
Tourette Syndrome and Persistent Motor/Vocal Tic Disorder affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. Chronic tics are the primary symptom. Comprehensive Behavioral Intervention for Tics (CBIT) is a manualized treatment focused on tic management skills. During the core CBIT procedure, competing response training, patients learn to inhibit tics by engaging in a competing motor action. The overall objective of this study is to identify bio-behavioral predictors and correlates of response and the most potent aspects of CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Neural, behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded. CBIT process will be measured with a video-based behavioral coding scheme that will be refined and validated during years 1-2 using archival CBIT videos
The goal of this observational study is to explore the impact of a resiliency and trauma informed care educational intervention for Psychiatric Mental Health Nurse Practitioner (PMHNP) students at the University of Arizona College of Nursing during the final, clinical year of the program. Specifically, the investigators will examine if the educational intervention is feasible, acceptable and helpful to students, and can decrease burnout and increase resiliency.
To determine what proportion of patients have inferior angle recess dimensions that could accommodate the OTX-TIC, and what are risk factors for implant contact with the corneal endothelium.
The purpose of this protocol is to examine treatment outcomes of youth receiving the Comprehensive Behavioral Intervention for Tics (CBIT) and better understand the predictors, moderators, mediators and/or mechanisms of change for this intervention.
To assess efficacy, and safety of a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT)
The purpose to the current study was to examine the efficacy of a telehealth, group-based, combined and intensive intervention for youth with tic disorders (TDs) and common co-occurring diagnoses. Families seeking treatment for TDs and common co-occurring diagnoses will be randomly assigned to receive treatment immediate (enrollment in the next group) or remain on a 1-month waitlist, and then receive treatment. Outcomes will be assessed across the treatment phase, immediately following treatment (post), as well as 1-month following the end of treatment.
To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.
This pilot study aims evaluate the feasibility and initial efficacy of behavior therapy augmented by d-cycloserine (DCS) compared to behavior therapy augmented by placebo. After an initial assessment to determine eligibility, youth with TD will be randomly assigned to receive four sessions of behavior therapy augmented by either DCS or placebo. D-cycloserine is an FDA-approved antibiotic medication that has been shown to enhance extinction learning in several studies. The investigators' proof-of-concept work has found that a single session of DCS-augmented behavior therapy reduced the severity of tics targeted in treatment on the Hopkins Motor/Vocal Tic Scale (HM/VTS) compared to placebo-augmented behavior therapy. This highlights the exciting potential of combining DCS with behavior therapy to improve reductions in tic severity. However, prior to a large-scale clinical trial, it is essential to determine the feasibility and efficacy of augmenting behavior therapy with DCS over multiple treatment sessions.
The purpose of this study is to evaluate the effectiveness of a computerized handwriting training protocol (MovAlyzeR), through daily practice of handwriting on an electronic device to improve handwriting skills in children with tic disorders (TD).
This is a single-arm open trial of Comprehensive Behavioral Intervention for Tics (CBIT) delivered to pediatric and adult patients with persistent tic disorders in their homes via videoconferencing (i.e., teleCBIT). All participants who enroll will receive teleCBIT.
Tourette Syndrome (TS) and Persistent Tic Disorder (PTD) are chronic and potentially disabling neurobiological conditions. Although a range of pharmacological and psychosocial treatments exists, a significant number of individuals either do not respond to the current treatments or find them unacceptable. Thus, it is essential that researchers continue to develop and test novel treatment approaches. In this randomized controlled trial the investigators will compare two different online group-based interventions for tics: a mindfulness-based program (Mindfulness-based Intervention for Tics (MBIT), and a psychoeducational and supportive therapy program (Tic Information and Coping Strategies (TICS)). The purpose of this study is to determine which intervention is more helpful for adults with a tic disorder.