Ignite Creation Date:
2024-05-06 @ 1:47 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04124367
Status:
TERMINATED
Last Update Posted:
2022-07-28
First Post:
2019-10-10
Brief Title:
IMPULSE - StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE
Sponsor:
Ever Neuro Pharma GmbH
Organization:
Ever Neuro Pharma GmbH
Study Overview
Official Title:
IMPULSE StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE A Prospective Multi-center Randomized Double-blind Study to Assess Efficacy and Safety of Neuroplastic Intervention by Cerebrolysin and atDCS on Motor Function Recovery in Subacute and Chronic Stroke Patients
Status:
TERMINATED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
for strategic and pandemic reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPULSE
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None