84 Clinical Trials for Various Conditions
Individuals with Huntington's Disease have impaired social cognition, which is the domain of cognition that allows individuals to understand others' perspectives so that they can navigate interpersonal actions successfully (e.g., understanding someone may be sad based of their facial emotion or tone of voice and then responding in a sympathetic manner). Impaired social cognition is associated with impaired social functioning, poor psychological wellbeing and increased caregiver burden, which is known to be significant among those who care for individuals with Huntington's Disease. Computerized social cognition training has been shown to improve social cognition in individuals with schizophrenia, who, like individuals with Huntington's disease, have cognitive impairments. The investigators propose a pilot study of computerized social cognition training in individuals with Huntington's disease. This will be a feasibility study that aims to show that social cognition training in HD can be studied in preparation for a larger randomized controlled trial. The investigators hypothesize that social cognition training can improve social cognition, social functioning, and quality of life in individuals with Huntington's Disease and decrease caregiver burden among those who care for individuals with Huntington's Disease.
The long-term goal of this project is to evaluate whether a procedure termed transcranial interference stimulation (tIS) may be useful in the future in the treatment of severe neuropsychiatric disorders such as schizophrenia. The purpose of this stage of the project is to evaluate the safety and tolerability of tIS administration in healthy volunteers. This study involves 30 healthy participants without known psychiatric illness, who will participate in groups of 10. The dose of tIS will be escalated progressively across doses. Functional magnetic resonance imaging (fMRI), magnetic resonance spectroscopy (MRS) and side effect checklists will be used to assess tIS safety/tolerability at each dose. In addition, electroencephalogram (EEG) will be collected simultaneously with tIS and used to assess target engagement. Face emotion recognition (FER) data will also be collected, but will be used for feasibility assessment only. If successful, these studies will form the basis for future studies in schizophrenia.
This study aims to assess changes in empathy levels before and after residential treatment among individuals with substance use disorders.
The goal of this clinical trial is to examine if iTBS applied to the DMPFC improves social cognitive performance compared to sham stimulation in people diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified. The main objectives of this trial are: * Compare changes in social cognitive performance between the active vs. sham treatment groups * Compare changes in social cognitive network functional connectivity between the active vs. sham treatment groups Each participant will receive iTBS (active or sham) five days per week for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at pre-treatment, post-treatment, and 6 months after the completion of treatment.
The investigators are studying how certain drugs can reduce anger outbursts in people with anger problems. In this study the investigators seek to determine if a single 34 mg (two 17 mg tablets) oral dose of the 5-HT2a receptor blocker, pimavanserin, will reduce aggressive responding in individuals with impulsive aggression (Intermittent Explosive Disorder: IED) on a laboratory task that assesses aggression (Taylor Aggression Paradigm: TAP). We will also be examining how this drug impacts hostile social cognition e.g., hostile attribution). If pimvanserin reduces aggression in this study a next step would be a placebo-controlled treatment trial of pimavanserin in study participants with IED. Participation will first involve a remote (e.g., TEAMS) screening session. If potential study participants appear eligible they will come into the lab for an in-person session where participants will complete interviews and questionnaires and have a medical evaluation (including a physical exam, electrocardiogram, and screens for alcohol and drug use). During the next study session, participants will complete a diagnostic interview and a series of questionnaires, all of which can all take place on-line. During the next two sessions (which will be in-person) participants will undergo two (2) study sessions during which study participants will be given a study drug (orally). The drug given, pimavanserin, is currently available and is known to block serotonin receptors thought to be involved in regulating anger. After participants take the study drug, study participants will complete questionnaires and computer tasks for assessment of aggression and of hostile social cognition. Each of these two in-person study sessions will take at least eight (8) hours. A final on-line session will be done to make certain the investigators have all the data required by the study protocol.
This proposal aims to study the role that the dorsal prefrontal cortex plays in human social cognition.
Difficulties in reciprocal social interaction are hallmark features of several neuropsychiatric disorders, most notably autism spectrum disorder (ASD) and schizophrenia spectrum disorder (SSD). While recent studies have demonstrated substantial overlap in genetic etiology between ASD and SSD, little is known about common versus unique neural mechanisms that may underlie these downstream social deficits that cross diagnostic boundaries. Thus, a comprehensive imaging study examining social deficits in youth with ASD and adolescent- onset SSD at the neurochemical, connectivity, as well as functional activation level will be crucial in furthering our understanding of these underlying neural mechanisms. Specifically, the current project aims to examine how targeted social skills interventions may impact the organization of large-scale functional brain networks implicated in social cognition in these disorders, leading to improved outcomes. Thirty adolescents with ASD and 30 adolescents with SSD will undergo the Program for the Education and Enrichment of Relational Skills (PEERS), which is a 16-week parent-assisted social skills intervention that aims to improve friendship quality and social skills in teens with social difficulties. All participants will receive pre- and post-treatment MRI scans including functional MRI and magnetic resonance spectroscopy to quantify neural changes resulting from the intervention. All participants will also receive behavioral and social cognition assessments pre- and post-intervention to quantify real- world gains in social behaviors resulting from the intervention. Additionally, 30 typically developing adolescents will be recruited to serve as control participants and undergo two MRI and behavioral assessment sessions 16-weeks apart with no intervention in between. Specific aims include (1) examining inter-group disruptions in connectivity patterns, activation levels, and neurometabolite concentrations in key social brain regions pre-treatment in ASD and SSD groups, (2) examining inter-group changes in connectivity patterns, activation levels, and neurometabolite concentrations in key social brain regions in response to treatment in ASD and SSD groups, and, (3) dimensionally identifying intra-group differences in brain responses and how they relate to real-world treatment outcomes.
There are many ways to improve wellbeing. This study will compare two 8-week wellbeing training programs. In addition to looking at how well the programs reduce stress and enhance wellbeing, the investigators will also ask questions about how these programs influence cognition and decision making.
This study will evaluate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on neural and behavioral facets of social cognition in Autism Spectrum Disorder (ASD). Participant visits will include a baseline assessment of neuropsychological, cognitive and behavioral function, and an EEG (electroencephalogram) and eye-tracking session to measure neural and visual attentional social response before and after administration of TMS.
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder that is increasing in prevalence, and is characterized by deficits in social communication and interaction across multiple contexts, and restricted, repetitive patterns of behavior, interests, or activities. The majority of individuals with ASD have poor outcomes in the area of social functioning; however, there are no medical treatments available that target the core social communication deficits. The goal of the proposed research is to understand the neurobiological role of an imbalance in excitatory (glutamate) and inhibitory (gamma-aminobutyric acid, GABA) neurotransmission in the social cognition deficits in ASD, and to develop proton magnetic resonance spectroscopy as a measurement of target engagement to measure the ability of a medication, gabapentin, to increase cortical GABA levels. Spectrally-edited proton magnetic resonance spectroscopy (1H-MRS) provides an ideal method for measuring cortical GABA levels. All proposed studies will be in 70 adolescents (male and female) with ASD (age 13 to 17 years). Specific Aim 1: To measure correlations of 1H-MRS GABA levels in the anterior cingulate cortex (ACC) and occipital cortex (OC) with clinical measures of social cognition at baseline. Specific Aim 2: To measure the effect of an initial one time dose of gabapentin on 1H-MRS GABA levels in the ACC and OC. The hypotheses are 1) that higher social cognition ability will be positively correlated with GABA in the ACC but not in the OC (a control, non-social cognition-related region) of individuals with ASD, and 2) that gabapentin will increase GABA levels in the ACC and OC of youth with ASD.
The primary objective of this study is to determine the efficacy and feasibility of a battery of neuropsychological measures evaluating social cognition and behavior in young adults diagnosed with schizophrenia, autism spectrum disorders, or traumatic brain injury (TBI). It also investigates functional differences in regions of the brain associated with social cognition and differences in cognitive processing. Additionally, this study implements a virtual reality intervention to strengthen social cognition skills.
Survivors of pediatric medulloblastoma (MB) are at-risk for neurocognitive and social deficits, including specific skills such as facial affect recognition which is the ability to recognize the emotional expressions of another person. Because the underlying mechanisms of these deficits are poorly understood, the investigators propose to examine social-cognitive skills (i.e. facial affect recognition) and indices of brain integrity, including an established core neural network of face perception in MB survivors and healthy controls. By comparing these outcomes between survivors of MB and healthy controls, investigators seek to identify the areas of the brain that help individuals recognize emotions. Primary Objective: * To evaluate social cognition in adolescent and young adult survivors of pediatric medulloblastoma. Secondary Objective: * To examine indices of brain integrity and function and their association with facial affect recognition in survivors of pediatric medulloblastoma.
Purpose: To collect outcome measures such as eye tracking and questionnaire data prior to and following a group based clinical therapy program to determine the effectiveness of the therapy approach. The therapy program is aimed at improving social cognitions and skills of individuals who find social situations difficult, stressful and/or uncomfortable and with a desire to enhance skills required for social interactions. Participants: Cohorts of individuals aged 10-69 years old with symptoms of a neurodevelopment disorder, who have general difficulty with social interactions. Procedures: Participants enrolled in a clinical therapy program for improvement of social cognitions and skills will complete eye tracking tasks, several questionnaires and rating scales, and a diagnostic interview prior to and following the 8 week therapy program. The post treatment assessments will be conducted within a week of the therapy completion and then again approximately 2 months after the last therapy session. The entire study duration is expected to be approximately 17 weeks. These outcome measures will measure the effectiveness of the treatment.
This study is a multi-site, prospective, parallel arm, double-blind, randomized, controlled clinical trial to assess the efficacy of an experimental software program targeting social cognitive abilities versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.
Social cognition impairment is critical to the pathology and morbidity of a number of psychiatric disorders, including the schizophrenia spectrum, the autism spectrum and the personality disorders, thus representing a dimension consistent with RDoC. As such, this study aims to a) further characterize the unique deficits in social cognition (recognition and interpretation of social cues and representation of thoughts, intentions, and feelings of others) across disorders, including the schizophrenia spectrum (which includes schizophrenia, SCZ, schizoaffective disorder, SAD, bipolar disorder, BD, and schizotypal personality disorder, SPD), the autism spectrum disorders (ASD), and borderline personality disorder (BPD) compared to healthy controls (HC); b) assess the effect of intranasal oxytocin (OXT) as a regulator and novel treatment of social cognition impairment in these disorders; and c) enhance our understanding of the specificity and exact mechanisms of impairment to inform the accurate dosing of OXT required to modulate social cognition in these disorders and identify a model of optimum social cognitive function. Addressing these questions will further catalyze research into a model of optimum social cognitive activity, and accelerate industry development of agents suited to routine clinical administration.
The purpose of this study is to predict and explain on the basis of brain function and structure the behavioral and brain effects of an evidence-based intervention for adults with high-functioning autism, Virtual Reality-Social Cognition Training (Kandalaft et al., 2012; Journal of Autism and Developmental Disorders). Adults with autism will be randomly assigned to receive either (a) two hours per week of intervention services for five weeks, or (b) a treatment as usual control. The intervention will focus on enhancing social skills, social cognition, and social functioning. Outcome measures will evaluate changes in these social skills, cognition, and functioning using standardized assessments. We will perform structural and functional magnetic resonance imaging (MRI) scans at three time points-before, during, and after treatment (i.e., Time Point #1, 2, and 3).
The study looks at whether treatment with iloperidone (Fanapt) is associated with improvements in social cognition in individuals who have been recently diagnosed with schizophrenia or schizoaffective disorder. Social cognition (the ability to understand your feelings and the feelings of others) is closely related to functional outcomes, including communication, empathy, and emotional recognition.
This is a randomized, placebo controlled, double blind crossover study of the effects of intranasal oxytocin on social cognition, implicit preferences and craving in moderate to heavy social alcohol drinkers.
In the current study, the investigators propose to measure the five domains of social cognition identified by the National Institute of Mental Health (NIMH) as relevant to individuals with psychosis (i.e., theory of mind, attribution style, emotion recognition, social perception, and social knowledge). The investigators will also explore the association between different domains of social cognition and outcomes relevant to psychotic disorder (e.g., symptomatology, social functioning, and vocational functioning).
This study will evaluate whether oxytocin will facilitate the learning of social cognitive skills in schizophrenia patients who receive 12 sessions of Social Cognitive Skills Training (SCST). The primary hypothesis is that schizophrenia subjects who are treated with oxytocin will demonstrate greater improvements in a summary measure of social cognition than subjects treated with placebo over the course of SCST.
Individuals with schizophrenia have been found to have deficits in social cognition, which is defined as the functions that are engaged during social interactions. Social cognition has been found to be critical in predicting multiple aspects of community functioning. There are no currently available medications that have been consistently found to improve social cognition in individuals with schizophrenia. Oxytocin functions as a neurotransmitter that is thought to be involved in multiple aspects of social behavior and related emotions. In this study, we test the hypothesis that acute administration of intranasal oxytocin will improve social cognition in individuals with schizophrenia.
Veterans with schizophrenia and schizoaffective disorder experience high levels of disability and poor community outcome, and these poor functional outcomes constitute a major public health concern. The treatment of schizophrenia spectrum disorders has shifted fundamentally from a focus on symptom reduction to a focus on recovery and improving aspects of functioning. Needed improvements in community outcome for patients with these disorders will not occur simply through better control of clinical symptoms. Instead, it is necessary to find new treatments that address the key determinants of poor functional outcome, including social cognition. Both basic (non-social) cognition and social cognition are considered key determinants of functional outcome for schizophrenia and schizoaffective disorder. Basic cognition includes the domains of: learning and memory, vigilance / attention, speed of processing, reasoning and problem solving, and working memory. Social cognition generally refers to mental operations that underlie social interactions, including perceiving, interpreting, managing, and generating responses to socially relevant stimuli, including the intentions and behaviors of others. As part of the investigators' previous Merit grant, they have developed a training program for social cognition and are in the process of validating it. Initial results suggest that the program improves performance on measures of social cognition and functional capacity. In this study, the investigators will evaluate whether adding an in vivo component (training activities that occur in the community) to the current social cognition intervention facilitates generalization of training effects to community outcome and subjective satisfaction. Outcome measures of social cognition and functional capacity will be examined during the 12 week training program, and durability of benefits will be assessed at a 3-month follow up. Generalization to community functioning and subjective satisfaction will be assessed at the end of training and at the 3-month follow up. The investigators will enroll 105 patients across the 5 years of the study with random assignment to training group (social cognition intervention with in vivo exercises, social cognition intervention without in vivo exercises and control). Subjects will receive assessments at baseline, 6 weeks (mid-point), completion of training (12 weeks), and the 3-month follow up.
This study examines the effects of a single dose of intranasal oxytocin (vs. placebo) on complex social cognition in adults with autism spectrum disorders.
Objective: Social Cognition and Emotional Intelligence have been shown to be deficient in patients with schizophrenia and these are not remediated by antipsychotic medications or psychosocial interventions. Social cognition is associated with functional outcome, an important step in striving for recovery in this population. The hormone and neurotransmitter, oxytocin, which has been associated with social bonding and trust has been shown to improve measures of some aspects of social cognition in humans. The study will assess the effect of acute administration of intranasal oxytocin on measures of social cognition and functioning as well as on emotional intelligence and symptoms. Study population: The study population will include patients with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who have been on a stable medication regimen for 6 weeks. We will enroll a total of 30 subjects (N=15 placebo and N=15 oxytocin groups). Experimental design and methods: After a one week lead in phase, participants will undergo 3 weeks of oxytocin (20 IU BID) or placebo administration (double blind) in addition to their existing medication regimen. Outcome measures will be administered during the lead in phase, and at the end of the study drug administration phase (under the acute effect of OT). The primary outcome measure will be the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) and the Maryland Assessment of Social Competence (MASC). Secondary measures include rating from the domains of social cognition (emotion perception, attributional style, theory of mind and social perception), symptom rating and measures of social anxiety and quality of life. Side effects and symptoms will be measured weekly.
This study will determine the effectiveness of social cognition and interaction training, a manual-based group therapy program, in helping people with schizophrenia improve their social cognition and social functioning.
The term social cognition refers to how social information is processed. Individuals with schizophrenia and schizoaffective disorder have been shown to have significant deficits in social cognition. Moreover, it has been speculated that these deficits may in turn have a negative impact on their overall functioning. Behavioral interventions targeting social cognition are just beginning to emerge, and there is a need to evaluate their efficacy. Objectives: This is a small trial evaluating the efficacy of social cognition interaction training (SCIT) an experimental behavioral treatment for improving social cognition in schizophrenia. Research Design and Methodology: Approximately 48 participants with schizophrenia-spectrum disorders will be randomized into one of two conditions: 1) a 20 to 24 session manualized social cognition interaction training group (SCIT), or 2) wait-list control. Pre-and post-group therapy assessments of symptoms, social cognition, basic cognition, and community function will be conducted. Data obtained from this study will allow us to determine the efficacy of SCIT training in improving symptom, cognitive, and functional measures.
Veterans with schizophrenia and schizoaffective disorder experience very high levels of disability and poor community outcome. Further improvements in community outcome for patients with these disorders will not occur simply through better control of clinical symptoms. Instead, it will be necessary to find treatments that address the key determinants of poor functional outcome. Evidence strongly suggests that basic (non-social) cognitive and social cognitive deficits are among the key determinants of functional outcome for these illnesses. The primary goal of this 2-year pilot study is to implement and validate a new remediation program for social cognition that is appropriate for veterans with schizophrenia and schizoaffective disorder.
The purpose of this project is to investigate the possible effect of intranasally administered Oxytocin (OT) on specific mirror neuron areas in human brain. The mirror neuron system (MNS) is thought to be involved in action perception and understanding, and may also underlie more complex cognitive processes such as imitation. We will use electroencephalographic (EEG) investigations to examine brain activity while participants complete two different tasks, consisting of the observation and imitation of emotional facial expressions (video presented) and the observation and execution of simple grasping actions (live presented), respectively. In addition, before the beginning of the EEG recording session, subjects will be randomly assigned to two different groups (Oxytocin or Placebo group) and will receive a dose of either intranasal Oxytocin or Placebo solution. Oxytocin is a polypeptide hormone that plays a critical role in social behavior. We will identify mu and beta rhythm from the ongoing EEG and examine suppression as a function of emotion and goal directed action perception and imitation/execution.
In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia. Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia. Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved in emotional or sarcastic communication) after administration of oxytocin versus placebo. Hypothesis B: Patients and healthy comparison subjects will show increased attention to others' eyes and patients will exhibit increased facial affect expressivity after administration of oxytocin versus placebo. Aim 2: To examine the effects of exogenous oxytocin on persistent negative symptoms in schizophrenia (PNS) activity in patients with recent-onset schizophrenia. Hypothesis A: Patients and healthy comparison subjects will demonstrate increased PNS activity during social tasks after administration of oxytocin versus placebo. Hypothesis B (exploratory): Patients and healthy comparison subjects' improvements in social cognition and behavior will be predicted by the degree to which oxytocin increases their PNS activity.
The specific aim of this proposal is to investigate the neurophysiological mechanisms of oxytocin's (OT) prosocial effects in patients with schizophrenia and healthy subjects using magnetoencephalography. Hypothesis A: When OT is administered to patients with schizophrenia, fear-related amygdala hyperreactivity and fusiform gyrus (FG) and anterior cingulate cortex (ACC) hypoactivity will be normalized. Hypothesis B: When OT is administered to patients with schizophrenia, the decreased functional connectivity (FC) between the amygdala, FG, and ACC will be normalized. By elucidating the neurophysiological mechanisms of OT administration on emotional face processing, investigators will bee able to: 1. understand the pathophysiology of the functionally debilitating social cognitive deficits of schizophrenia, 2. test the efficacy of OT in normalizing the neural abnormalities underlying these social deficits, and 3. develop and optimize novel treatments for these currently untreatable deficits.