IMPULSE - StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Ever Neuro Pharma GmbH
Collaborators:
Evaluation Software Development GmbH NeuroConn GmbH VASCage GmbH