Cortical Ischemic Stroke and Serotonin

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study the investigators want to test the hypotheses that, serotonergic neuromodulation increases perilesional neuroplasticity, leading to improved behavioural outcomes through a more efficient allocation of functional resources, greater structural reorganization and less remapping via alternative circuits.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborator: Cantonal Hospital of St. Gallen
• Treatments: Citalopram; Dexetimide; Serotonin; Serotonin Uptake Inhibitors

Criteria

Inclusion Criteria:

• First-ever stroke

• Clinically significant contralesional hand plegia or paresis as a main symptom

• Involvement of the pre-and/or postcentral gyri confirmed on diffusion-weighted (DWI) and fluid attenuated inversion recovery (FLAIR) scans.

• Written informed consent

Exclusion Criteria:

• Aphasia or cognitive deficits severe enough to preclude understanding of study purposes

• Prior cerebrovascular events

• Significant stenosis (70-99% according to NASCET) or occlusion of the carotid and intracranial arteries on MR-angiography

• Purely subcortical stroke

• Known brain lesion (tumour, old cerebral haemorrhage)

• Other medical conditions interfering with task performance or SSRI-treatment, specifically: prolonged corrected QT interval (QTc) on electrocardiogram, ongoing drug / alcohol abuse

• Simultaneous intake of medications which can lead to prolonged QTc syndrome known or or suspected hypersensitivity (allergic) to one of the ingredients of Cipralex® or Placebo

• Simultaneous administration of: antidepressants, irreversible non- selective Monoamine Oxidase (MAO) inhibitors, reversible selective MAO inhibitors, reversible non-selective MAO inhibitors, irreversible selective MAO inhibitors, N-methyl-D-aspartate(NMDA)-receptor antagonists/-agonists, dopamine antagonists/-agonists, levodopa, benzodiazepines, amphetamines, methylphenidate, foscarnet, ganciclovir, ritonavir, mianserin, chloroquine, mefloquine, imipenem, penicillin, ampicillin, cephalosporins, metronidazole, isoniazid, levofloxacin, cyclosporin, chlorambucil, vincristine, methotrexate, cytosine arabinoside, lithium, anticholinergics,systemic antihistamines, systemic sympathomimetics

• Conditions interfering with MRI such as patients with magnetic (metallic) particles in the scull or brain, patients with a cardiac pacemaker, deep brain stimulators or cochlear implant.

• Women who are pregnant or breastfeeding

• Women in childbearing age without sufficient birth control (at least 2 contraceptive methods)

Eligibility Criteria for healthy volunteers:

• Normal test-scores at the baseline visit (see section 5.2.2)

• Normal neurological status

• No known brain lesion

• No pregnancy

• Written informed consent