Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT04124367
Eligibility Criteria:
Inclusion Criteria:
* 18-80 years of age, both inclusive, of all sexes
* 8 weeks to 12 months after a first-ever hemispheric subcortical ischemic stroke, confirmed by imaging
* Pre-stroke modified Rankin Scale (mRS) 0 or 1
* Action Research Arm Test (ARAT) score 13-50, both inclusive
* Shoulder Abduction Finger Extension (SAFE) score ≥5
* Patient participates voluntarily and gave written informed consent
Exclusion Criteria:
Disease-related:
o Study procedures:
1. Severe sensory deficits (score of 2 on item 8 of the NIHSS)
2. Severe aphasia (a score of ≥2 on item 9 of the NIHSS)
3. Severe neglect (a score of 2 on item 11 of the NIHSS)
4. Co-morbid conditions such as fractures, osteoarthritis, fixed or severely interfering contraction or deformity in the affected limb, polyneuropathy and/or ischemic peripheral disease if the sensorimotor functions of the upper extremities are affected, other neurological disease(s) or known brain abnormalities, acute coronary syndrome, severe heart disease (NYHA class III or IV), cancer, severe liver disease (hepatic disease associated with coagulopathy \[prothrombin time prolonged beyond the normal range\] and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C), and other major medical conditions that, in the opinion of the site investigator, might influence efficacy or safety assessment
5. MMSE \<20
6. Current drug or alcohol use or dependency that would interfere with adherence to study procedures
7. Participation in another interventional study
* Spasticity:
8. Major spasticity as indicated by the Modified Ashworth Spasticity Scale \>2/4 in either elbow flexors, wrist flexors or finger flexors of the affected limb
9. Injection of botulinum toxin to the affected upper limb in the last three months, or the need of an injection of botulinum toxin anytime during the study period
10. Injection of phenol to the affected upper limb in the last six months, or the need of an injection of phenol anytime during the study period
Exposure-related:
11. Pacemaker or brain stimulator
12. Implanted intracranial metals in the stimulation area such as clipping, coilings, ventriculo-peritoneal shunts, endoprosthesis, cochlear implant
13. Scalp wounds or infections in the area of stimulation
14. Any condition that would represent a contraindication for Cerebrolysin administration:
* hypersensitivity to one of the components of the drug
* epilepsy
* severe renal impairment (estimated glomerular filtration rate \[eGFR\] \<30 ml/min/1.73 m2 as assessed at local laboratory within one month before screening)
15. Breastfeeding; pregnant or trying to become pregnant
16. Concomitant medications
* with potential negative effects on cortical excitability or plasticity (e.g. psycholeptics (ATC class N05), antiepileptics, neuroleptics, benzodiazepines, dextromethorphan)
* with potential positive effects on cortical excitability or plasticity (e.g. SSRIs, SNRIs, dopaminergic preparations, memantine, AChEIs, amphetamines) - except if the patient is on a stable dose for a minimum of four weeks. Special attention should be given to possible additive effects when Cerebrolysin is used in conjunction with antidepressants/MAO inhibitors. High doses of MAO inhibitors in combination with higher dosages of Cerebrolysin (30-40 ml) have been reported to increase blood pressure.
* with neuroprotective/neurotrophic/nootropic effects (e.g. ginkgo biloba, erythropoietin, citicoline, amantadine, piracetam)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04124367
Study Brief:
Protocol Section:
NCT04124367