IMPULSE - StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE (IMPULSE)
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|ClinicalTrials.gov Identifier: NCT04124367|
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : July 1, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Stroke Subacute Stroke||Drug: Cerebrolysin Device: non-invasive brain stimulation Drug: Placebo Device: sham intervention||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||June 25, 2021|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
|Active Comparator: Verum||
30 ml once daily (+70 ml 0.9% saline)
Device: non-invasive brain stimulation
2 mA/35 cm² for 2x20 minutes, once daily
Other Name: atDCS
|Placebo Comparator: Control||
100 ml once daily 0.9% saline
Device: sham intervention
0 mA/35 cm² for 2x20 minutes, once daily Run-in phase consisting of ramp-up (10 seconds), stimulation (10 seconds), and ramp-down (10 seconds).
- Action Research Arm Test (ARAT) [ Time Frame: Day 21 ]The ARAT assesses upper limb functioning. The ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement. The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance.
- Nine-Hole Peg Test (NHPT) [ Time Frame: Day 21 ]The NHPT is used to measure finger dexterity. The NHPT is composed of a square board with 9 pegs. At one end of the board are holes for the pegs to fit in to, and at the other end is a shallow round dish to store the pegs. The NHPT is administered by asking the patient to take the pegs from a container, one by one, and placing them into the holes on the board, as quickly as possible. Patients must then remove the pegs from the holes, one by one, and replace them back into the container. Patients are scored based on the time taken to complete the test activity, recorded in seconds.
- Hand grip dynamometry [ Time Frame: Day 21 ]Hand grip dynamometry measures grip strength. The best out of three strength tests of the impaired hand is used as resultant score. A score is taken with the non-affected hand, followed by the impaired hand.
- National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: Day 21 ]The NIHSS is a 15-item impairment scale, intended to evaluate neurologic outcome and degree of recovery for patients with stroke. Total scores on the NIHSS range from 0 - 42, with higher values reflecting more severe cerebral infarcts and correspondingly more severe neurological impairment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124367
|Contact: Edith Doppler, PhD||0043766520555 ext email@example.com|
|Contact: Stefan Winter, PhD||0766520555 ext firstname.lastname@example.org|
|Bad Pirawarth, Austria, 2222|
|Contact: Andreas Winkler, MD, MSc +43 2574 29160|
|Principal Investigator:||Andreas Winkler, MD, MSc||Klinik Pirawarth|