Topics

IMPULSE - StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE

2019-10-17 11:03:42 | BioPortfolio

Summary

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.

Hypothesis:

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.

Study Design

Conditions

Chronic Stroke

Intervention

Cerebrolysin, non-invasive brain stimulation, Placebo, sham intervention

Location

Klinik Pirawarth
Bad Pirawarth
Austria
2222

Status

Not yet recruiting

Source

Ever Neuro Pharma GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-17T11:03:42-0400

Clinical Trials [6221 Associated Clinical Trials listed on BioPortfolio]

Effects of Non-invasive Brain Stimulation in Tobacco Use Disorder

The objective of the study is to determine the effect of non-invasive brain stimulation on craving for tobacco and brain metabolites.

Modulating Interaction of Motor Learning Networks in Rehabilitation of Stroke

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...

Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery

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 ...

Comparative Study to Test Safety and Efficacy of Neurotrophic and Cholinergic Treatment of Alzheimer's Disease

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 ...

High Definition Transcranial Direct Current Stimulation Motor Cortex Versus Insula

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...

PubMed Articles [21727 Associated PubMed Articles listed on BioPortfolio]

Inadequate description of placebo and sham controls in a review of recent trials.

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...

Systematic review and meta-analysis of placebo/sham controlled randomised trials of spinal cord stimulation for neuropathic pain.

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...

Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I-a randomized, placebo-controlled, double-blind, Asian-Pacific trial.

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.

Cerebrolysin improves peripheral inflammatory pain: Sex differences in two models of acute and chronic mechanical hypersensitivity.

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...

Efficacy and mechanisms of non-invasive brain stimulation to enhance exposure therapy: A review.

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...

Medical and Biotech [MESH] Definitions

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.

More From BioPortfolio on "IMPULSE - StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE"

Quick Search

Relevant Topics

Women's Health
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 ...


Searches Linking to this Trial