Clinical Research Directory

Patient-Centered NeuroRehabilitation (PCN)

As individuals grow older, a number of factors can reduce our cognitive (or thinking) abilities such as "normal" aging, neurodegenerative diseases, and cardiovascular disease. This study will evaluate whether cognitive rehabilitation and transcranial electrical stimulation (TES) can improve cognitive abilities. Cognitive rehabilitation refers to methods that are used to improve tasks people have trouble doing in everyday life. Transcranial electrical stimulation uses small amounts of electricity to try to alter brain functioning. These approaches may help improve cognitive abilities like attention, learning, memory, finding words, and problem solving as well as everyday functioning. The goal of this study is to identify how to best use these methods, either alone or in combination.

Factors Predicting Outcome in Group Treatment of Alcohol Use Disorders (AUDs)

Harmful alcohol use is a global risk factor for disease, injuries and death. Research on treatment of Alcohol use disorders (AUDs) indicates that different treatment modalities are equally effective, but also that a large group of patients do not change their drinking pattern despite being in treatment. It is assumed that it is not random who benefits from treatment. Thirty to forty percent of outcome variance in treatment is probably explained by patient factors, and we need more knowledge on how different patient factors moderate treatment effects. Further, clinicians also need more knowledge about selecting patients to different therapies. The present study will investigate how patient factors predict outcome in group treatment of AUDs, and what predicts positive treatment outcomes over time. The study is designed as a quasi-experimental, multi-centre, follow-up study. Patients will be included from Vestfold Hospital Trust, Borgestadklinikken, Blue Cross Clinic, Behandlingssenteret Eina, Blue Cross Clinic and A-senteret, Oslo, Church City Mission. The Project will provide more knowledge about patients seeking treatment for AUDs, and specifically how patient factors predict outcome in group treatment. These results will in turn lead to better selection of treatment modalities, and patients will receive a more effective treatment earlier on. Main aims: 1) How do patient factors predict outcome in group treatment of alcohol use disorders (AUDs)? 2) Do positive treatment outcomes last over time? Specifically, do the following factors: a) psychiatric comorbidity b) severity of alcohol use pre-treatment c) personality disorders and d) cognitive impairments predict 1) completion of group treatment and 2) positive outcome after 1 year. As an additional aim, we will investigate if the Montreal Cognitive Assessment test (MoCa) is feasible as a brief screening instrument for mild cognitive impairments for AUD patients.

Studying the Effects of Brain Stimulation on Cognitive Control and Associated EEG in Human Subjects.

This is a basic neuroscience study of modulating brain oscillations involved in cognitive control. We will record brain signals and stimulate specific regions of the brain in human participants who are undergoing monitoring for epilepsy surgery. It is not a clinical trial for treating any disease.

Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation

Inattentiveness and impulsivity in healthy adults and individuals with attention deficit hyperactivity disorder (ADHD) diminish these individuals' quality of life. Cortical hypometabolism has been hypothesized to contribute to inattentiveness in ADHD. Transcranial photobiomodulation (tPBM) is a safe and non-invasive modality for activation of the prefrontal cortex. tPBM in healthy adults has been shown to augment brain oxygenation, cognition, and mood. The cognition-enhancing effect of tPBM on sustained attention in adults with ADHD remains unstudied. The investigators will evaluate whether tPBM administration to adults with and without ADHD can improve their attention. Each participant will be screened for eighteen criteria based on the Diagnostic and Statistical Manual (DSM-IV, text revised), using the validated instrument Adult ADHD Self-Report Scale (ASRS-v1.1). Blinded participants will be randomized into (I) Active-tPBM or (II) Sham-tPBM groups. After undergoing an 8-minute administration of Sham or 1064 nm tPBM to the lateral and medial right prefrontal cortex, each participant will complete a 14-minute, computer-based Conner's continuous performance task-3 (CPT-3). The investigators will examine whether adults with and without ADHD who receive Active-tPBM improve in measures of inattention, impulsivity, sustained attention, or vigilance compared to the Sham-tPBM group. Cognitive assessments of attention like the CPT-3 may evaluate the efficacy of tPBM to increase cortical metabolism in healthy adults and individuals with conditions like ADHD. The investigators anticipate their investigation will be a starting point for more sophisticated studies that focus on the implications of tPBM on cognition.

Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation

The first aim of this project is to investigate the effects of different high-tech neurorehabilitation interventions (cognitive, motor, and combined cognitive-motor) on both cognitive and motor disability outcomes in people with multiple sclerosis (MS). The second aim is to identify the cognitive and motor profiles of MS patients who benefit the most from either the combined cognitive-motor rehabilitation intervention or the isolated cognitive or motor treatments.

Minocycline in Neurocognitive Outcomes - Sickle Cell Disease

Sickle cell disease (SCD) is a common, inherited blood disorder that primarily affects people of African Ancestry. It has a lot of complications including neurological complications. The neurological complications of SCD are particularly devastating and lead to cognitive decline even in the absence of overt brain injury. In such cases, it is thought that inflammation in the brain maybe partly responsible for the cognitive decline. The main reasons for this research study are to see 1) how safe and 2) how well minocycline works to try to stop/reverse cognitive decline in people with SCD. People with SCD are at risk for changes in their brain over time that can cause problems with learning, memory, and attention. Part of the reason for this is inflammation within the brain. Minocycline may be able to stop these brain changes by stopping this brain inflammation. Minocycline is a second-generation tetracycline antibiotic that has been shown to both inhibit neuroinflammation and improve cognitive function in a variety of neurodegenerative and psychiatric disorders but has not yet been studied in SCD. We are proposing here, a pilot double-blinded, randomized controlled trial to examine the tolerability and early efficacy of minocycline in adults with SCD at two dosing regimens (200 mg and 300 mg daily) versus placebo over one year. Participants will undergo a neuropsychological exam using the NIH Toolbox Cognition Battery at both study enrollment and exit (after one year) to assess for changes/stability of cognition. Participants will receive monthly phone calls/text messages to assess for adverse events and will be seen every three months for pill counts and routine laboratory monitoring. The primary outcome will be a comparison of adverse events across the two dosing strategies versus placebo. Early evidence for cognitive benefit will also be assessed from the results of the NIH Toolbox.

Neurorehabilitation Through Hippotherapy of a Brain Stroke

Cerebrovascular accident \[CVA\] (medical term for stroke) is a high burden worldwide disorder and the second leading cause of disability. As illustrated by the number of survivors that remain disabled after a CVA (2 out of 3 according to the US National Stroke Association), recovery is limited, and novel neurorehabilitation approaches are urgently needed. Hippotherapy is an emerging specialized rehabilitation approach, performed by accredited health professionals on a specially trained horse via its movement. A body of scientific evidence has gradually emerged in recent years, showing robust benefits of hippotherapy in various massive neurological disabling conditions including brain stroke. The aim of the study is to analyze the effect of a hippotherapy program of several cycles delivered during 22 weeks in total, on the functional and global evolution of post-stroke patients (with a score of Rankin ≥ 3 at inclusion) during the outpatient rehabilitation phase. A second purpose is to measure the impact of the intervention on the quality of life of their close caregivers. A prospective clinical trial on the effectiveness of hippotherapy versus conventional outpatient rehabilitation alone will be carried out. The 22-weeks program includes three cycles of hippotherapy as follows: an initial 2-weeks cycle, an intermediate 1-week cycle and a final 1-week cycle. One-hour daily sessions will be conducted during each cycle exclusive additional rehabilitation care. After each cycle, the patients will have a 9-weeks rest period where they will continue their conventional therapy. A battery of clinical tests will measure both functional and psychological outcome. The primary end point will be the functional independence of the patient. The secondary end points will consider the patient's sensorimotor and cognitive function, the severity of stroke and the quality of life, as well as the caregivers' burden and quality of life. Program evaluation is important in neurorehabilitation to ensure that patients are achieving meaningful outcomes from the care. A primary question is how do stroke patients clinically evolve after being discharged from the hospital and how stable is the achieved rehabilitation outcome. Hippotherapy optimizes brain plasticity and has a strong impact on the global rehabilitation process and functional outcome of these patients. A remaining question concerns the improvement of the caregivers' quality of life.

Validation of the Lithuanian Version of the BNSS, CDSS, and the SCoRS

This study aims to validate the Lithuanian version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale in a Lithuanian sample. This will be done by comparing results obtained from the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale with results obtained from the Positive and Negative Symptoms Scale, the Montgomery Asberg Depression Rating Scale, and the Montreal Cognitive Assessment test.