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Mild Neurocognitive Disorder clinical trials

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NCT ID: NCT06143488 Recruiting - Clinical trials for Acute Ischemic Stroke

Endovascular Therapy Versus Best Medical Treatment for Acute Large Vessel Occlusion Stroke With Low NIHSS

Start date: January 4, 2024
Phase: N/A
Study type: Interventional

Patients presenting with mild symptoms of acute ischemic stroke are common and account for approximately half of all acute ischemic stroke. About 30% of patients with minor stroke have a 90-day functional disability. Radiologically proven a large vessel occlusion (LVO) in patients with minor stroke is a well-established predictor of poor outcomes, while the poor outcomes following best medical management in patients with minor stroke with the underlying presence of a LVO are mainly driven by the occurrence of early neurological deterioration (END). Considering the well-known strong association between lack of arterial recanalization and END, endovascular therapy (EVT) appears as an attractive option to improve functional outcomes for LVO-related patients with stroke with mild symptoms. Whether EVT is safe and effective in patients with mild stroke with an LVO is currently debated, since these patients were typically excluded from the pivotal EVT trials. The current study aimed to further test the hypothesis that endovascular therapy would be superior to medical management with respect to functional recovery among low NIHSS patients caused by acute large-vessel occlusion in the anterior circulation.

NCT ID: NCT06130735 Recruiting - Clinical trials for Mild Cognitive Impairment

Impact of Intensive Computerized Cognitive Training

CCT
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

To investigate factors that predict cognitive enhancement following engagement in an intensive Computerized Cognitive Training Protocol.

NCT ID: NCT05984667 Recruiting - Brain Tumor Clinical Trials

C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors

C-SMART
Start date: September 15, 2023
Phase:
Study type: Observational

The primary aims of this mixed-methods trial are to test the feasibility and acceptability of the novel Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) delivered via telehealth to patients with primary brain tumors and mild neurocognitive disorder (mNCD).

NCT ID: NCT05602467 Recruiting - Clinical trials for Mild Neurocognitive Disorder

Long Term Transcranial Pulse Stimulation (TPS) on Older Adults With Mild Neurocognitive Disorder (NCD)

Start date: November 25, 2022
Phase: N/A
Study type: Interventional

Background: Dementia, now known as major neurocognitive disorder (NCD), is a great health burden in Hong Kong and worldwide. In principle, to achieve its optimal benefits, intervention for dementia should begin at the earliest preclinical stage, which is defined as mild cognitive impairment (MCI). However, no evidence has been found to support a pharmacological approach to the prevention or postponement of cognitive decline during the stage of mild NCD. Non-invasive brain stimulation (NIBS) is increasingly recognized as a potential alternative to tackle this problem. The typical examples of NIBS are transcranial direct current stimulation (DCS) and transcranial magnetic stimulation (MS). Besides these, there is a new NIBS named transcranial pulse stimulation (TPS), which recently obtained CE marking in 2018 for the treatment of the central nervous system (CNS) in patients with mild to moderate Alzheimer's disease (AD). TPS is using repetitive single ultrashort pulses in the ultrasound frequency range to stimulate the brain. With a neuro-navigation device, TPS can achieve this in a highly focal and precisely targeted manner. TPS differs from DCS and TMS using direct or induced electric current. Instead, TPS provides good spatial precision and resolution to noninvasively modulate subcortical areas, despite the problem of skull attenuation. Using lower ultrasound frequencies TPS can successfully improve skull penetration in humans. TPS has shown its neuroprotective effects through inducing long term neuroplastic changes, supported by neuropsychological tests and neuroimaging investigations both in animal and human studies. Mild NCD is a golden period for intervention to avoid further progression to dementia. Although TPS has great potential as a new treatment option due to its neuroprotective effects, there is no TPS study done on mild CD subjects according to our knowledge. To determine the effectiveness of TPS in mild NCD, an open-label pilot study was conducted by our team from Dec 2020 to Dec 2021. The preliminary result was presented in the 2021 Brain Stimulation Conference and published in abstract format. We recruited 16 older adults who had mild CD. They received 6 sessions of TPS over 2 weeks. Assessments were done at the 3 time points. No subjects dropped out during the study. Statistically significant improvement was found in the primary outcome, HK-MoCA, from 18.06 to 20.25. The improvement was maintained till 12 weeks after the TPS intervention. No adverse effect was observed. The result suggested that TPS is likely to have an immediate effect on global cognition in mild CD, and the improvements were sustainable. However, a 2-week treatment duration may not be long enough to induce a significant change in neurodegenerative disease in long term. Up to date, there is no long-term NIBS treatment done on NCD. Therefore, we plan to conduct a pilot case-controlled trial to evaluate the efficacy of long-term TPS on cognition and brain structure in patients with mild ND based on the results of our pilot study. Objective: This study is to determine the efficacy of a 24-week program (32 sessions) of TPS in older adults with mild NCD. We hypothesized that TPS group is significantly more effective than control group in maintain or improve the global cognitive function measured by Hong Kong Chinese version of Montreal Cognitive Assessment (HK-MoCA) in patients with mild NCD. Design: This case-controlled trial will assess the efficacy of a 24-week TPS program on cognition and brain structure in subjects with mild NCD. All eligible participants will receive an intervention trial of TPS. They would receive 2 sets of stimulation programs, each set lasting 12-weeks. Participants would receive 3 sessions/week in the first 2 weeks and then 1 session/week in the subsequent 10 weeks. A total of 32 sessions (2 sets of 16 sessions) ofTPS will be delivered, with each session lasting 30 minutes. Data Analysis: The primary and secondary outcomes will be assessed at baseline, immediately after the 1st set of stimulation program (12th week), 2nd set of stimulation program (24th week), and 12 weeks after the intervention (36th week). The primary outcome will be the change of the Hong Kong Chinese version of the Montreal Cognitive Assessment (HK-MoCA). The secondary outcome includes specific cognitive domains, daily functioning, mood, and apathy. The intention-to-treat analysis would be carried out. Pre and post-intervention brain MRI scans will be used during the intervention to evaluate the changes in brain structure. A checklist of potential adverse effects associated with TPS administration will be generated from the available literature. Blood pressure and heart rate will be recorded at the beginning and at the end of the TPS intervention course.

NCT ID: NCT05387057 Completed - Clinical trials for Mild Neurocognitive Disorder

Effectiveness of a Novel Exergame-Based Training Concept for Older Adults With Mild Neurocognitive Disorder

Start date: June 22, 2022
Phase: N/A
Study type: Interventional

BACKGROUND: Simultaneous motor-cognitive training interventions are considered promising to prevent the decline in cognitive functioning in older adults with mild neurocognitive disorder (mNCD) and can be highly motivating when applied in form of exergames. OBJECTIVES: This study systematically explores the effectiveness of a newly developed exergame-based motor-cognitive training concept (called 'Brain-IT') targeted to improve cognitive functioning in older adults with mNCD. METHODS: A two-arm, parallel-group, single-blinded (i.e. outcome evaluator of pre- and post-measurements blinded to group allocation) randomized controlled trial with an allocation ration of 1 : 1 (i.e. intervention : control) including 34 - 40 older adults with mNCD will be conducted between May 2022 and December 2023. The control group will proceed with usual care as provided by the (memory) clinics where the patients are recruited while the intervention group will perform a twelve-week training intervention according to the newly developed 'Brain-IT' exergame-based training concept in addition to usual care. As a primary outcome, global cognitive functioning will be assessed using the Quick Mild Cognitive Impairment Screen (Qmci). As secondary outcomes, domain-specific cognitive functioning, brain structure and function, spatiotemporal parameters of gait, instrumental activities of daily living, psychosocial factors (e.g. quality of life, and levels of depression, anxiety, stress), and cardiac vagal modulation (heart rate variability at rest) will be assessed. Both, the pre- and the post-measurements will take place within two weeks prior to starting or after completing the intervention.

NCT ID: NCT05331560 Recruiting - Clinical trials for Mild Neurocognitive Disorder

Transcranial Pulse Stimulation Open-label Self-controlled Trial For Mild Neurocognitive Disorder

Start date: January 20, 2020
Phase: N/A
Study type: Interventional

Background: A significant proportion of older adults suffered from age-related diseases particularly dementia, also known as major neurocognitive disorder (NCD), which is becoming a worldwide health burden. In principle, Interventions for dementia should have optimal benefits at the earliest preclinical stage yet no evidence has been found to support a particular pharmacological approach in preventing cognitive decline during the stage of mild NCD. Non-invasive brain stimulation (NIBS), on the other hand, is increasingly recognized as a potential alternative to tackle this problem. Typical NIBS include transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). A new kind of NIBS named Transcranial Pulse stimulation (TPS) is also recently used for treating patients with Alzheimer's disease (AD).TPS is a kind of NIBS that uses repetitive sin ultrashort pulses in the ultrasound frequency range to stimulate the brain, and it can provide better spatial precision and reach deeper brain regions comparing to tDCS and TMS. The mechanism of TPS is to convert the mechanical TPS stimulus into biochemical responses, thus influence some fundamental cell functions. A recent study showed that there is a significant improvement in using TPS in treating AD. However, there has been no study investigating the effect of TPS on older adults with mild NCD. Objective: This study is an open-label self-controlled study to assess the effectiveness and tolerability of TPS on cognition in older adults with mild NCD. We hypothesized that a 2-week TPS intervention could significantly improve patient's global cognition which will be maintained for 12 weeks. Design: The current study is an open-label self-controlled interventional trial of TPS guided by neuro-navigation using structural MRI. All participants will undergo the treatment as usual (TAU) period as self-controlled for 12 weeks. They will then receive a six-session TPS intervention for 2 weeks with three sessions per week. A 12 weeks post-intervention assessment will then be conducted. Data Analysis: Primary outcome and secondary outcomes assessment would be carried out at baseline, after TAU period, immediately after the intervention and 12 weeks after the intervention. The primary outcome will be the change of the Hong Kong Chinese version of the Montreal Cognitive Assessment (HK-MoCA). The secondary outcome includes specific cognitive domains, daily functioning, mood, and apathy. The intention-to-treat analysis would be carried out. Significance: The result of the current study would provide further data on the effectiveness and tolerability of TPS as a new treatment in patients with mild NCD.

NCT ID: NCT04996654 Completed - Clinical trials for Mild Neurocognitive Disorder

Feasibility of a Novel Exergame-Based Training Concept for Older Adults With Mild Neurocognitive Disorder

Start date: July 12, 2021
Phase: N/A
Study type: Interventional

The primary objective of this pilot study is to evaluate the feasibility (i.e. recruitment, adherence, compliance, attrition), usability (i.e. system usability), and acceptance (i.e. enjoyment, training motivation and perceived usefulness) of a newly developed exergame-based intervention concept for older adults with mNCD. As a secondary objective, preliminary effects of the intervention on cognition, brain resting-state functional connectivity, gait, cardiac autonomic regulation, and psychosocial factors (i.e. quality of life, and levels of depression, anxiety, and stress) will be explored. This allows to synthesize data for a sample size calculation on basis of a formal power calculation for a future RCT. A two-arm, parallel-group, single-blinded (i.e. outcome evaluator of pre- and post-measurements blinded to group allocation) pilot randomized controlled study with an allocation ration of 2 : 1 (i.e. intervention : control) including 17 - 25 older adults with mNCD will be conducted between June and December 2021. The active control group will proceed with usual care as provided by the memory clinics where the patients are recruited. The intervention group will perform a twelve-week training intervention according to a newly developed exergame-based intervention concept in addition to usual care. Primary outcomes will be assessed throughout the training intervention period. The measurements of all secondary outcomes will be conducted at ETH Hönggerberg within two weeks prior to starting (PRE) and after completing (POST) the study intervention.

NCT ID: NCT03331796 Completed - Clinical trials for Mild Cognitive Impairment

Noninvasive Brain Stimulation for Mild Cognitive Impairment

Start date: May 16, 2018
Phase: N/A
Study type: Interventional

The goal of this study is to test the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as a treatment for Mild Cognitive Impairment (MCI). Participants will be randomly assigned to one of three treatment groups: Group 1: Active Dorsolateral Prefrontal Cortex (DLPFC) rTMS; Group 2: Active Lateral Parietal Cortex (LPC) rTMS; and Group 3: Inactive rTMS (Placebo) control (evenly split between each coil location). Participation in the study takes approximately 7 ½ months-including a 2-to 4-week treatment phase (20 rTMS sessions) and a 6-month follow-up phase.

NCT ID: NCT03095170 Terminated - Clinical trials for Mild Cognitive Impairment

Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder

PEACEOFMND
Start date: March 23, 2017
Phase: N/A
Study type: Interventional

Behavioral interventions currently provide the most useful approach to addressing the behavioral and social needs of those with Mild Cognitive Impairment (MCI) due to Alzheimer's or other diseases. This randomized, multisite, 3-arm study will investigate the impact of computerized brain fitness vs yoga vs an active control group (wellness education) on changes in cognitive function, daily functioning and quality of life in persons with Mild Cognitive Impairment (MCI) and their partner. In addition, in vivo neuroimaging measures of plasticity during the pre- and post-intervention periods will be measured and compared between the three different treatment groups. These neuroimaging measures of plasticity will be investigated in their relationship to the cognitive outcomes within each group.

NCT ID: NCT02647645 Terminated - HIV Clinical Trials

Cognitive Training With and Without tDCS to Improve Cognition in HIV

Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to develop pilot data on the potential efficacy of computer-based cognitive training or the combination of computer-based cognitive training with transcranial direct current stimulation (tDCS) in improving cognitive function in persons with HIV-related mild neurocognitive disorder (MND).