136 Clinical Trials for Various Conditions
The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to \[\>=\] 6 and less than \[\<\] 12 years of age), adolescents (\>=12 and \<18 years of age), and adults (\>=18 years of age) with Tourette's Syndrome (TS).
Tourette Syndrome
The investigator will apply 16 sessions of repetitive transcranial magnetic stimulation (rTMS) over 4 consecutive days for adult patients suffering from Tourette's Syndrome. Following rTMS, patients will undergo 8 sessions of Comprehensive Behavioral Intervention for Tics (CBIT) over 10 weeks via telemedicine. Clinical improvement in tic severity will be the primary outcome measure. Secondary outcome measures including underlying physiological effects will be measured via functional magnetic resonance imaginge (fMRI), high-density electroencephalograhy (HD-EEG), and TMS.
Tourette Syndrome
Aversive sensory phenomena such as premonitory urges play a central role in the behavioral treatment model of tics. Extinction learning and extinction recall are learning processes implicated within this model, but are still understudied for individuals with Tourette syndrome (TS). This study examines extinction learning and extinction recall in adults with TS using an experimental task. This study will also explore the relationship between extinction processes (i.e., extinction learning and extinction recall) and treatment outcomes with behavior therapy. Findings from this investigation will be used to update the behavioral treatment model, which serves as the basis for evidence-based behavioral interventions.
Tourette Syndrome, Habit Reversal Training, Tic Disorders, Tics, Comprehensive Behavioral Intervention for Tics
This study evaluates the effect of ecopipam tablets in children and adolescents in the treatment of Tourette's Syndrome (TS). Half of the participants will receive ecopipam tablets, while the other half will receive matching placebo tablets
Tourette Syndrome
Aversive sensory phenomena such as premonitory urges play a central role in the behavioral treatment model of tics. Extinction learning and extinction recall are learning processes implicated within this model, but have not been directly evaluated in youth with Tourette syndrome (TS). This study examines extinction learning and extinction recall in youth with TS using an experimental task. This study will also explore the relationship between extinction processes (i.e., extinction learning and extinction recall) and treatment outcomes with behavior therapy. Findings from this investigation will be used to update the behavioral treatment model, which serves as the basis for evidence-based behavioral interventions.
Tourette Syndrome in Children, Tourette Syndrome in Adolescence, Habit Reversal Training, Tic
This is an investigator-initiated proof of concept study with the purpose to examine the safety, tolerability and feasibility of Dronabinol (synthetic Δ9-THC) and PEA for the treatment of adults with Tourette syndrome.
Tourette Syndrome
This is an open-label study of SNC-102 (acamprosate calcium sustained release tablet) in adult subjects with Tourette Syndrome. Subjects will be treated with oral doses of SNC-102 800 mg on a BID basis - before breakfast and at bedtime - for 4 weeks and the same subjects will be treated with SNC-102 1600mg in the morning and 800mg in the evening for an additional 4 weeks. Subjects will be assessed for changes in tic severity, safety, and pharmacokinetics. The study hypothesis is that treatment with SNC-102 will improve the tic severity in adult subjects with Tourette Syndrome.
Tourette Syndrome
Our intervention will be the injection of Abobotulinum toxin A into the affected site/vocal cords for patients with the diagnosis of Primary Tourette's syndrome. This is an efficacy trial to understand the right dosage of Abobotulinum toxin A which can be affective. The study will involve an injection of 2.5 units of Dysport on each side of the affected vocal cords for patients with a diagnosis of Primary Tourette's syndrome. The patients will also complete a self assessment survey on how vocal tics affect their daily lives. Afterward, a further evaluation of the tics will be conducted by the investigator using the Yale Global Tic Severity Scale. (YGTSS) evaluation. How this will be done is by a licensed ENT (Ear, Nose and Throat) physician. The windpipe will be number by a 2% lidocaine followed by a provoked cough by the patient. This will allow the lidocaine to be sprayed throughout the airway preventing coughing and swallowing during the procedure. An Electromyography (EMG) guidance a needle containing Dysport will be injected into the thyroarytenoid muscles will potentially reduce the vocal dyskinetic features in patients with TS. This needle will be connected to a syringe and once determined active, it will be placed appropriately when the EMG emits a characteristic sound. If this does not occur with the patient then the injection will be administered under direct vision via direct laryngoscopy using an orotracheal injector system. This procedure is conducted in an outpatient clinic because no hospitalization is required. The patient is not allowed to consume food or drink for about 45-60 minutes after the injection. The throat will be numb and may cause coughing and some blood tinged sputum: The expectancy of this outcome is reason to not consider is a serious event. Asprin and ibuprofen is not allowed a week prior to and until the injection at least 3-4 days after to prevent excessive bleeding. The patient is also instructed to ensure that they chew their food thoroughly and drink sufficient water for the initial days after the study intervention. Mild dysphasia may be noted initially which should resolve within a few hours. On Visit 1, the patient will complete all required study documents and forms. Then the ENT physician will proceed with the injection Dysport on the same day. If unforeseen circumstances render the subject unable to be injected on the same day, the intervention must take place within three days and this will be considered V1, follow up events should be scheduled accordingly.
Tourette Syndrome, Chronic Vocal Tic
Tourette's Syndrome is a neurological disease characterized by motor and vocal tics. It has been hypothesized that abnormal interactions of dopamine with its receptors may cause the tics. The purpose of this study is to test the hypothesis that a drug (ecopipam) that selectively blocks dopamine D1/D5 receptors can reduce the frequency and severity of the tics.
Tourette's Syndrome
The purpose of this study is to assess the feasibility of a trial on an oral orthotic for reducing tic severity in children ages 7-25 years with Tourette syndrome (TS) or Chronic Tic Disorder (CTD).
Tourette Syndrome, Chronic Tic Disorder
The purpose of this study is to evaluate the effectiveness and safety of deep brain stimulation (DBS) as a possible new treatment for Tourette Syndrome (TS). This investigation will (1) test the hypothesis that centromedian (CM) continuous brain stimulation will be an effective, safe method for the treatment of tics in medication refractory TS, (2) will define the intra-operative and post-operative physiological changes, and (3) will test the hypothesis that responsive brain stimulation (RBS) will provide an alternative to chronic DBS in TS.
Tourette Syndrome
This is a two-part, randomized, multi-center, blinded study in adolescents with Tourette's Disorder. There will be an up to 21-day screening period in which subject eligibility will be determined. In Part 1 of the study, the safety, tolerability and pharmacokinetics of AZD5213 will be assessed during a 1- week period. In Part 2 of the study, the safety, tolerability, and preliminary efficacy of two doses (depending on tolerability in Part 1 of the study) of AZD5213 and placebo will be assessed through six consecutive four-week crossover periods. Each subject will receive both AZD5213 and placebo. A follow-up vist will take place at 14 (±) 7 days following the last dose of study drug.
Tourette Syndrome
The goal of the current trial is to determine safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.
Tourette's Disorder, Tic Disorder
The goal of the current trial is to determine efficacy and safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.
Tourette's Disorder, Tic Disorder
The purpose of this study is to evaluate the safety and efficacy of an investigational compound designated PF-03654746 compared to placebo in the treatment of adults with Tourette's Syndrome. The study will also explore the pharmacokinetics of PF-03654746 in adults with Tourette's Syndrome.
Tourette's 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.
Tourette Syndrome
The purpose of this trial is to determine whether a particular type of Deep Brain Stimulation (DBS), scheduled Deep Brain stimulation (SBS), is an effective and safe treatment for Tourettte syndrome (TS). The trial will also examine the brain activity associated with TS and tics and explore the possibility of responsive brain stimulation (RBS).
Tourette Syndrome
Tourette's Syndrome is a neurological disease characterized by verbal and motor tics. The currently available drug treatments are considered to be inadequate. This clinical trial is designed to test if ecopipam is effective for the treatment of Tourette's Syndrome in adults.
Tourette's Syndrome
Tourette syndrome is a childhood-onset neuropsychiatric disorder characterized by multiple motor and vocal tics that last for at least a year in duration. Currently, there exist several effective pharmacological treatments for childhood tics including alpha-2 agonist medications (guanfacine and clonidine) and neuroleptics (antipsychotic) medications. These medications, however, have significant side-effects and are only partially efficacy in treating tics. N-acetylcysteine (NAC) is a natural supplement that acts as an antioxidant and glutamate modulating agent. NAC has been used safely for decades in doses 20-40 times higher than in this trial as an antidote for acetaminophen overdose. The only side-effect commonly seen with NAC is nausea and this side-effect is seldom seen in the doses used in this trial. NAC has recently been demonstrated to be effective in a double-blind, placebo-controlled trial in adults with trichotillomania (chronic hair pulling). Hairpulling is hypothesized to be closely related to tics because these conditions (1) have similar clinical characteristics -- both groups typically experience urges before engaging in pulling or tics, (2) neuroimaging studies suggest they involve similar brain circuits -- the basal ganglia, (3) the same pharmacological treatments (neuroleptics) may be effective for both conditions and (4) they tend to be inherited together in families. In other trials NAC has evidence of some efficacy in treating diverse psychiatric conditions such as bipolar depression, schizophrenia and cocaine dependence. The investigators are conducting this trial to determine if NAC is an effective treatment for tics.
Tourettes Syndrome, Tic
This study will evaluate the clinical efficacy of 1 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the supplementary motor area (SMA) in Tourette's Syndrome (TS) patients who have not fully responded to conventional therapies. The investigators will collect TMS measures of motor cortex excitability to test whether rTMS restores normal levels of intracortical inhibition found to be deficient in TS. The investigators will administer neuropsychological tests to demonstrate that SMA targeted rTMS can be administered safely without significant impairments of cognitive or motor functioning. The investigators hypothesize that: 1. Compared to sham (placebo), active rTMS will improve symptoms of TS as assessed with the Yale Global Tic Severity Scale (Y-GTSS) and Clinical Global Impression (CGI). 2. Active (but not sham) rTMS will normalize levels of motor cortex excitability, as reflected by increased intracortical inhibition, motor threshold, and cortical silent period, and by decreased intracortical facilitation, relative to pre-treatment baseline.
Tourette Syndrome
This study will investigate how the sensitivity to touch and smell in patients with Tourette syndrome (TS) may differ from that of people without TS. TS is a neurological disorder that causes people to have uncontrolled movements called "tics." A tic can also be vocal, like a cough or bark or string of bad words. The tic is preceded by a "premonitory urge" that may feel like an itch or pressure that builds until the tic occurs. To some patients, the tic feels like a response to an involuntary sensation. In patients with TS, sensory information may be processed differently than it is in people without TS. This study will compare how strong a sensation feels in TS patients and healthy volunteers. It will also look for muscle activity that may be responsible for the feelings in the area of the tic. Healthy normal volunteers and people with Tourette syndrome, 18 to 65 years of age, may be eligible for this study. Candidates are screened with a medical history and brief physical and neurological examinations. TS patients complete a questionnaire about their tics and are interviewed by a psychiatrist. Women who can become pregnant will have a urine pregnancy test prior to any other procedures. Pregnant women cannot participate. All participants undergo sensory testing for touch and smell. They are asked to distinguish between a scented and scentless object and rate how strongly they feel the scent. Later, with their eyes closed, they are asked to tell whether or not they are being touched, and to rate how intensely they felt the touch. In addition to the sensory testing, TS patients, but not normal volunteers, undergo electromyography (EMG), a test that measures the electrical activity of muscles. For surface EMG, small metal disks called electrodes are filled with a conductive gel and taped to the skin. Wire EMG involves inserting a wire into a muscle using a needle. All patients have surface EMG and those who consent to it will also have wire EMG.
Tourette's Syndrome
This is an open-label, flexible dose study designed to evaluate the safety and efficacy of aripiprazole in TS (or chronic tic disorder) subjects with or without associated OC symptoms and with or without ADHD symptoms.
Tourette's Syndrome
The purpose of this study is to determine if Abilify will reduce tics (repetitive, uncontrollable movements or vocalizations) in children and adolescents ages 7-18 with Tourette's Disorder (TD) or a chronic motor tic disorder (either repetitive, uncontrollable movements or vocalizations).
Tourette's Syndrome, Tic Disorders
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. ...
Tourette Syndrome
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). ...
Tourette Syndrome, Tic Disorders
This K23 Career Development Award is designed to provide the training needed for the PI to achieve her long-term career goal of conducting independent, programmatic intervention research in developmental populations. The training will emphasize gaining expertise in higher-intensity, multi-method, within-subject data collection and analysis. This award builds on the PI's emerging experience in tic disorders and pediatric behavioral interventions, and her ability to quickly learn and apply advanced statistical methods. The award will extend the PI's training through the following short-term training goals: 1) multi-method data collection and integration (electronic momentary assessment \[EMA\], wearable devices, neurocognitive tasks), 2) leading and designing pediatric clinical trials, 3) managing and analyzing large, multilevel datasets, and 4) career development and contribution to the field. The PI has developed a training plan to accomplish these goals in concert with her mentors, a team of leading experts in the fields of psychiatry and psychology, who will closely monitor training through regular meetings. The highly structured training plan also includes a set of formal coursework and workshops for each training goal to complement the hands-on experience the PI will gain from leading the research project. The objective of this proposal is to comprehensively map symptom change across time and during a behavioral intervention for youth with Persistent Tic Disorders (PTDs). PTDs affect approximately 1% of the population, can cause significant disability, have high rates of comorbidity, and are associated with a four-fold increase in suicide risk. Research has established that tic symptoms and their change over time are highly idiographic. However, first-line, evidence-based, existing interventions are "one-size-fits-all," and are only effective for 60% of patients. The current study aims to use advanced statistical methods and a novel theoretical framework to map the stability of tic patterns, along with systemic factors that relate to tic change over time. Study hypotheses, based on the literature and preliminary data, are that a) tic change patterns will be stable before intervention for all participants, b) disruption of stable patterns during the intervention phase will be associated with treatment response, and c) this disruption will depend on the specific driver of tic symptoms pre-intervention. N = 30 youth ages 12-17 with chronic tics will be recruited for the study. There will be three study phases: 1) pre-intervention (4 weeks), 2) intervention (8 weeks), and 3) post-intervention (4 weeks). Before and between each phase, participants will complete 4 traditional assessments to assess symptoms and treatment response. Throughout the 16 weeks of the study, we will collect EMA data focused on factors relevant to tics (4x per day), physiological data from wearable devices (passive, continuous), and neurocognitive task performance and tic video observation (1x per week). Results will inform efforts to develop individualized interventions for individuals with PTDs to improve treatment outcomes.
Tourette Syndrome, Tic Disorders
This study is designed to evaluate the efficacy and safety of gemlapodect (NOE-105) on reducing tics associated with Tourette Syndrome (TS) in adults with TS. Adolescents will be enrolled after a sentinel cohort of adults is complete.
Tourette Syndrome
Decades of Tourette Syndrome (TS) neuroimaging research has revealed abnormal cortical and subcortical motor system network, hypothesized to result from maladaptive plasticity. Repetitive transcranial magnetic stimulation (\[r\]TMS) is a promising technology that utilizes the concept of neuroplasticity to modulate brain circuits. TMS modulation has the distinct advantage in terms of its non-invasive nature. Furthermore, unique stimulation paradigms such as intermittent theta-burst repetitive TMS (iTBS) allows for short stimulation time (\<3 min). Using a sham-controlled protocol, the investigators propose modulating pre-SMA output using iTBS, based on our prior data of abnormal pre-SMA-mediated motor system regulation. hypothesize pre-SMA modulation results in increased pre-SMA-mediated motor inhibition. Enhancing these inhibitory measures with pre-SMA-iTBS provides the basis for improving inhibitory function in TS patients, leading to our long-term goal of neuro-stimulation to achieve clinical tic reduction.
Tourette Syndrome, Tourette Syndrome in Children, Tourette Syndrome in Adolescence, Tourette Syndrome, Modifier of
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period.
Tourette Disorder
This is a clinical trial where adolescents aged 10-16 years old with Tourette Syndrome (or chronic tic disorder) are randomized to receive either real-time functional magnetic resonance imaging (fMRI) neurofeedback targeting the supplementary motor area (for the experimental intervention) or real-time fMRI neurofeedback (NF) from a control region (for the control intervention).
Tourette Syndrome in Adolescence