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NCT ID: NCT06309888 Recruiting - Spinal Cord Injury Clinical Trials

Magnetic Resonance Imaging of Cognitive Deficits in the Brain of Individuals With Spinal Cord Injury

SCI_Cog
Start date: February 1, 2024
Phase:
Study type: Observational

In the case of spinal cord injury, rehabilitation is particularly focused on motor skills. Non-motor impairments such as thinking difficulties did not receive a lot of attention to date. In this research project, the investigators want to find out how thinking difficulties become noticeable in the brain with spinal cord injury. Participation procedure: Participants who take part will be asked to come to an examination once. The duration of the examination is between 2 and 2.5 hours (including around 55 minutes in the magnetic resonance imaging scanner, including preparation and follow-up).

NCT ID: NCT06305156 Recruiting - Bone Loss Clinical Trials

Protocol Optimization in CT for the Quantification of BMD

Start date: March 13, 2024
Phase: N/A
Study type: Interventional

Bone mineral density is an important measurement to detect osteoporosis. The goal of this clinical trial is to compare bone mineral density measurements in CT examinations and DXA scans. The main question it aims to answer is: - How good is the measurement of bone mineral density in the new photon-counting CT in comparison to DXA - How can we optimize the CT scan for bone mineral density Participants will undergo: - Clinically indicated CT scan on day of inclusion - Study related DXA scan on a separate appointment

NCT ID: NCT06304077 Recruiting - Stress Clinical Trials

Restorative Environments for Gait Therapy With VR

REGaitVR
Start date: April 23, 2024
Phase: N/A
Study type: Interventional

The aim of our study is to investigate the effects of landscapes during gait therapy. The investigators will evaluate the impacts of restorative landscapes as they occur in urban, rural and forest environments. Older people will experience those landscapes using virtual reality (VR) goggles during their gait training. The investigators expect the landscapes to have an effect on the following three aspects: (1) stress reduction, (2) restoration of attention and (3) change in gait parameters. For this purpose, volunteers who are currently inpatient in one of our study centers and already participating in gait therapy will be assigned to a group. The control group will receive the standard therapy. The participants of the intervention groups will receive five additional VR training sessions to the standard therapy. In these sessions, the participants will walk through urban, rural and forest landscapes and perform balance improvement exercises. The five training sessions will take place within ten days. Allocation to the control or intervention groups and their landscapes is random. At the start and end of participation, tests defining stress levels and gait parameters are carried out so that comparisons can be made between before and after treatment. The goal of the study is to find out which type of landscape supports restoration and can therefore contribute to greater gait stability. The investigators expect that improved gait stability will be promoted by stress reduction and increased attention induced by the virtual environments. The investigators are investigating the consequences of repeated application of virtual landscapes and the relationship between the effect of the landscape and the preferences and habits of the study participants.

NCT ID: NCT06302686 Recruiting - Clinical trials for Mild Cognitive Impairment

engAGE: Managing cognitivE decliNe throuGh Theatre Therapy, Artificial Intelligence and Social Robots drivEn Interventions

engAGE
Start date: October 9, 2023
Phase: N/A
Study type: Interventional

The objectives of the engAGE project are to counteract and slow down cognitive decline progression, to enhance the intrinsic capacity of the users, and to support the wellbeing of older persons with mild cognitive impairment (MCI) by providing an ecosystem of services based on an innovative system that integrates social robots.

NCT ID: NCT06301282 Recruiting - Parkinson Disease Clinical Trials

Electroencephalographic Signatures of Neuropsychiatric Fluctuations in Parkinson's Disease

Transition
Start date: March 3, 2023
Phase:
Study type: Observational

Dopaminergic replacement therapy while efficient at reducing symptoms of Parkinson's disease is however often associated with motor and non-motor fluctuations which have a severe impact on patient quality of life. To date, the interplay between cortical activity linked to motor and non-motor symptoms and Parkinson's disease fluctuations linked to dopaminergic medication remain poorly understood. The aim of the study is to characterize the cortical electroencephalographic oscillatory correlates of Parkinson's disease motor and non-motor fluctuations and the temporal dynamics of their dopaminergic modulation. For this purpose, the investigators will apply an innovative approach using the differential non-linear temporal dynamics of motor and non-motor state during the transition from the dopaminergic withdrawal phase (i.e. OFF-levodopa state) to the dopaminergic effect phase (i.e. ON-levodopa state) following an acute levodopa administration. This research will allow to precisely disentangle the network dynamics subtending motor and non-motor symptoms of Parkinson's disease as well as precisely identify the electroencephalographic spectral modulations explaining the neuropsychiatric effects of levodopa. The identification of such biomarkers could pave the way toward innovative therapeutic approaches such as neurofeedback and transmagnetic stimulation.

NCT ID: NCT06298955 Recruiting - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria

Start date: February 19, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the long-term safety and tolerability of repeat-dose OMS906 5 mg/kg IV administration at 8-week intervals in patients with PNH.

NCT ID: NCT06296069 Recruiting - Stroke Clinical Trials

Exergames on an Unstable Surface in Stroke Inpatients

Start date: February 28, 2024
Phase: N/A
Study type: Interventional

Aim of this study is to assess the feasibility and effects of exergame-based cognitive-motor training on a labile platform on physical and cognitive functioning in stroke inpatients. This is two-armed pilot randomized controlled trial taking place in an inpatient neurologic rehabilitation clinic. A total of 30 persons that are undergoing inpatient rehabilitation due to a stroke will be randomly assigned to either the intervention group (IG) or the control group (CG). Participants of the IG will receive exergame-based motor-cognitive training on a labile surface, whereas participants of the CG will train on a stable surface. Primary outcome is feasibility comprising measures of adherence, attrition, safety and usability. Secondary outcomes will be measures of cognitive (psychomotor speed, inhibition, selective attention, cognitive flexibility, brain activity) and motor (functional mobility, gait speed, balance, proprioception) functioning.

NCT ID: NCT06295614 Recruiting - Parkinson Disease Clinical Trials

Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease

SPARKL
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to assess the preliminary safety and efficacy of the ARC-IM spinal cord stimulation therapy in alleviating locomotor deficits in individuals with Parkinson's disease. The ARC-IM Therapy employs epidural electrical stimulation (EES) to modulate leg muscle recruitment, with the aim of improving mobility deficits. The ultimate goal is to enhance the quality of life of people with Parkinson's disease.

NCT ID: NCT06291896 Recruiting - Clinical trials for Women's Health: Neoplasm of Breast

A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection

Start date: March 15, 2024
Phase: N/A
Study type: Interventional

This is an open, multicentric, interventional, prospective, non-randomized clinical investigation. The first aim of the study is to confirm that MammoWave reaches sensitivity>75% and specificity>90% in breast cancer (BC) detection on 10.000 volunteers undergoing regular screening programs.

NCT ID: NCT06283927 Recruiting - Glioblastoma Clinical Trials

The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)

RECSUR
Start date: January 1, 2023
Phase:
Study type: Observational

Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups. This study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year. The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.