Clinical Research Directory

Etiology-Phenotype-Outcome Pathway Study on Freezing of Gait (FOG)

This study is a prospective, multicenter, observational cohort (patient registry) designed to better understand freezing of gait (FOG), a disabling walking problem that can occur in Parkinson's disease and other related neurological conditions.The purpose of this registry is to collect long-term clinical information from patients with freezing of gait or gait and balance problems, and to explore how different causes of FOG are related to symptoms, walking patterns, falls, disease progression, and outcomes over time. The study will include participants with Parkinson's disease and other conditions associated with freezing of gait.Participants will receive standard medical care as determined by their treating physicians. No experimental drugs or study-related treatments will be assigned as part of this registry. Clinical information will be collected during routine visits and follow-up assessments, including questionnaires, walking and balance evaluations, video recordings, and other commonly used clinical tests.The information collected in this study may help improve the understanding of freezing of gait, support better risk assessment for falls, and guide future research and clinical management strategies for patients with gait and balance disorders.

Functional Outcomes After LumbOpenitoneal Shunt Placement UndeR Local Anesthesia for Patients With Idiopathic Normal preSsure Hydrocephalus (FLOURISH) Trial

This study is a prospective observational registry study that enrolls all patients aged 60 years or older suspected of having idiopathic normal pressure hydrocephalus based on the Third Edition of the Guidelines for the Diagnosis and Treatment of Idiopathic Normal Pressure Hydrocephalus. From the cohort registered, patients judged to be candidates for surgery based on the 3rd Edition of the Guidelines for the Diagnosis and Treatment of Idiopathic Normal Pressure Hydrocephalus. These patients will be randomized 1:1 to undergo either ventriculoperitoneal shunt surgery under general anesthesia or lumbar peritoneal shunt surgery under local anesthesia. A randomized clinical trial would attest the non-inferiority of lumbar peritoneal shunt surgery under local anesthesia compared to ventriculoperitoneal shunt surgery under general anesthesia regarding the improvement in timed up-and-go test scores at 3 months post-surgery relative to pre-surgery levels.

Transcranial Ultrasound Assessment of Cerebral Pulsatility in Shunt Decision-making for Suspected Idiopathic Normal Pressure Hydrocephalus: a Prospective Cohort Study

This will be a single-center, prospective, analytical cohort study. All included patients will undergo transcranial ultrasound (TPI) with measurement of cerebral pulsatility parameters prior to subtractive lumbar puncture during hospitalization in the neurosurgery department, followed by a second ultrasound assessment either at one year after surgery for operated patients, or at one year after the initial ultrasound assessment for non-operated patients. This ultrasound evaluation will be integrated into the routine work-up, which is already systematically performed in cases of suspected idiopathic normal pressure hydrocephalus (iNPH). The neurosurgical team's decision to perform cerebrospinal fluid (CSF) shunting will be made blinded to the ultrasound measurements and based solely on the standard clinical protocol. The primary objective of the study is to demonstrate that the mean amplitude of cerebral pulsatility (MeanBTP) prior to subtractive lumbar puncture is significantly higher in patients who show clinical improvement 12 months after CSF shunting compared with those who do not, with a type I error risk (alpha) of 0.05."

Unsteady Gait in Older People May be a Common and Treatable Neurological Disease Associated With Increased Mortality

We live in an aging population and a third of the older population has a gait disorder that may cause institutionalization, and increased mortality. Sixteen percent of them have a slow, unsteady, neurological gait disorder, called Higher-Level Gait Disorder (HLGD). A known cause of HLGD is Idiopathic Normal Pressure Hydrocephalus (INPH), which is a treatable neurological disease. More than half of individuals with HLGD meet the diagnostic criteria for INPH as they have wide brain ventricles on MRI images of the brain, but far from all of these are in contact with the healthcare system. Possibly, HLGD without wide brain ventricles and where no other known explanation for the symptom is found could be a variant of or a precursor to INPH. Gait disorder is common among older people and can lead to falls and reduced quality of life. Complications after falls contribute to both increased mortality and increased costs in society. Therefore, it is important to have a solid knowledge of different types of gait disorders and how they can be treated. Our research will contribute with information about how HLGD affects the individual and how affected individuals can be investigated and helped. The disease mechanisms behind INPH and often behind HLGD are unknown. It is also unknown how often older individuals are affected by HLGD and how high the mortality is for those affected. It is likely that the incidence of HLGD is high and that it is linked to an increased mortality. It is also likely that the disease mechanism behind the symptom is the same as that of INPH and that HLGD can be detected with the help of brain imaging. In this epidemiological cohort study, we want to answer the following overarching questions: What is the incidence and mortality of HLGD and INPH? Can HLGD be predicted using biomarkers and what disease mechanism causes HLGD?

Efficacy in iNPH Shunting (PENS) Trial

The Placebo-Controlled Efficacy in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) trial is a multi-center blinded, randomized, placebo-controlled design investigation of cerebrospinal fluid (CSF) shunt surgery to study the shunt efficacy in iNPH patients.

Acetazolamide Trial in Normal Pressure Hydrocephalus

A pharmacological treatment to patients with normal pressure hydrocephalus (NPH) is missing. The aim is to investigate if acetazolamide given to patients with NPH improves gait function and study the pathophysiological mechanisms leading to reduced symptoms. Patients will be randomized to acetazolamide or placebo and duration of treatment will be from diagnosis to the day of shunt surgery. Target dose is 500 mg/day. Study design is a double-blind randomized controlled trial and the plan is to include 42-50 patients. The study is investigator-initiated without financial sponsorship from the industry.

Endoscopic Third Ventriculostomy vs. Ventriculoperitoneal Shunt in Idiopathic Normal Pressure Hydrocephalus (ENDOVEST)

The aim of this single-center, two-arm, open-labeled, randomized controlled clinical study is to compare two surgical interventions, endoscopic third ventriculostomy and ventriculoperitoneal shunt, in treating idiopathic normal pressure hydrocephalus in terms of clinical improvement.