Track topics on Twitter Track topics that are important to you
Stroke is a leading cause of adult long-term disability worldwide. Recovery of arm and hand function after stroke is limited to about 50% of patients and full recovery is achieved in only 12% of stroke survivors by 6 months after stroke. Within the first 8-12 weeks post-stroke, a proportional recovery of 70%, corresponding to good recovery, may be achieved, but at later stages no major gain is observed with current therapy practices. Accordingly, there is a need to find new potential therapeutic tools to enhance post-stroke motor recovery. Rehabilitation supported by neuroplastic intervention is a new and pragmatic therapeutic approach in the treatment of stroke, giving way to a concept of 'recovery enhancers'.
The objective of this study is to assess whether an additional therapy with Cerebrolysin and anodal transcranial direct current stimulation (atDCS) increases the success of conventional rehabilitation therapy in subacute and chronic stroke patients with unexploited potential for functional recovery despite intact structural and functional pathways in the brain.
The hypothesis is that the combination of Cerebrolysin and atDCS facilitates motor learning in subacute and chronic stroke patients. Accordingly, motor function recovery at day 21 post-baseline is expected to be higher in the verum group (conventional rehabilitation + task-specific motor training + Cerebrolysin + atDCS) as compared to the control group (conventional rehabilitation + task-specific motor training + placebo + sham-transcranial direct current stimulation).
The primary objective is to show a significantly higher proportional recovery rate in the Action Research Arm Test (ARAT) at day 21 post-baseline in the verum group as compared to the control group.
The secondary objective is to assess the impact of this neuroplastic intervention on finger dexterity (Nine-hole peg test - 9HPT), hand grip strength, and neurological deficits (National Institutes of Healths Stroke Scale - NIHSS) at the end of therapy (day 21 post-baseline). Safety data are collected throughout the study and thereafter in case of ongoing serious adverse events (SAEs) at study endpoint.
Optional secondary parameters include electroencephalography (EEG) parameters and Brain Derived Neurotrophic Factor (BDNF) status analyses to document plastic changes in the brain, in particular changes of the cortical network functionality during neurorehabilitation, and to assess the impact of neuroplastic intervention on the BDNF synthesis rate as well as the influence of different BDNF polymorphisms.
Cerebrolysin, non-invasive brain stimulation, Placebo, sham intervention
Not yet recruiting
Ever Neuro Pharma GmbH
Published on BioPortfolio: 2019-10-17T11:03:42-0400
The objective of the study is to determine the effect of non-invasive brain stimulation on craving for tobacco and brain metabolites.
This study uses a form on non-invasive brain stimulation called transcranial magnetic stimulation to understand 1) understand how the brain learns post-stroke and 2) assess non-invasive br...
The purpose of this study is to determine whether a non-painful, non-invasive, brain-stimulation technique called transcranial direct current stimulation (tDCS) combined with occupational ...
The study was performed to compare the safety and efficacy of Cerebrolysin (10 mililiters [ml]), Aricept (10 miligrams [mg]), and a combination of both treatments on cognitive performance ...
Brain stimulation is a technique that can alter cortical function and thus be suitable for treating pain. This is especially when pain is chronic and associated with functional and even st...
Poorly described placebo/sham controls inhibit appraisal of active intervention benefits and harms. The 12-item Template for Intervention Description and Replication (TIDieR) checklist was developed t...
The aims of this study review were to: systematically identify the current evidence base of randomised controlled trials (RCTs) of spinal cord stimulation (SCS) placebo (or 'sham') trials for neuropat...
To evaluate the safety and efficacy of Cerebrolysin as an add-on therapy to local standard treatment protocol in patients after moderate-to-severe traumatic brain injury.
Chronic inflammatory pain is a major health problem worldwide with high prevalence in women. Cerebrolysin is a multimodal neuropeptide preparation that crosses the blood brain barrier and displays neu...
Though cognitive behavioral techniques are generally effective in the treatment of anxiety disorders, some people fail to benefit from exposure therapy or experience a return of fear after terminating...
Stimulation of the brain, which is self-administered. The stimulation may result in negative or positive reinforcement.
Lung infections with the invasive forms of ASPERGILLUS, usually after surgery, transplantation, prolonged NEUTROPENIA or treatment with high-doses of CORTICOSTEROIDS. Invasive pulmonary aspergillosis can progress to CHRONIC NECROTIZING PULMONARY ASPERGILLOSIS or hematogenous spread to other organs.
Acute and chronic (see also BRAIN INJURIES, CHRONIC) injuries to the brain, including the cerebral hemispheres, CEREBELLUM, and BRAIN STEM. Clinical manifestations depend on the nature of injury. Diffuse trauma to the brain is frequently associated with DIFFUSE AXONAL INJURY or COMA, POST-TRAUMATIC. Localized injuries may be associated with NEUROBEHAVIORAL MANIFESTATIONS; HEMIPARESIS, or other focal neurologic deficits.
A technique of brain electric stimulation therapy which uses constant, low current delivered via ELECTRODES placed on various locations on the scalp.
Measurable changes in activities in the CEREBRAL CORTEX upon a stimulation. A change in cortical excitability as measured by various techniques (e.g., TRANSCRANIAL MAGNETIC STIMULATION) is associated with brain disorders.
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...
Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...
Stroke - Cerebrovascular Disease (CVA)
A stroke is a serious medical condition that occurs when the blood supply to part of the brain is cut off. Strokes are a medical emergency and prompt treatment is essential because the sooner a person receives treatment for a stroke, the less damage is ...