Criteria for discontinuing or modifying allocated interventions {11b}
stroke, CRF, seizures
ADVERSE EVENT, STROKE, EVENT, CRF, PREMATURE
In the event that the stimulation is not tolerable for the patient, it will be discussed with the patient whether they would like to retry at a later time (within the specified 14 days after the stroke event, s. eligibility criteria) or whether the study participation will be terminated. Modifications of the intervention are not planned to be performed.Reasons for premature termination of an individual trial subject are:DeathWithdrawal of consentPatient lost to follow‐upMajor protocol violationOccurrence of an Adverse Event or a Severe Adverse Event (e.g., seizures) that prevent the patient’s further safe participation in the trail.If, in the investigator’s opinion, continuation of the trial would be detrimental to the subject’s well‐being.pregnancyNoncomplianceThe PI decides on the withdrawal of a patient from study treatment in case one of the criteria mentioned above occurs. The reason for withdrawal will be recorded in the CRF as well as in the subject’s medical records. Premature termination should be prevented as best as possible. In case a subject withdraws from further participation at their own request, the reasons/circumstances will be determined and documented. All sessions and assessments of the last trial day will be performed and documented as well as the final status of the patient. Each withdrawn patient should enter the follow-up phase. The patient will not suffer any disadvantage in case of requested withdrawal of any further study procedure participation including the follow up.. Adverse Events (AEs)/ Serious Adverse Events (SAEs) should be followed‐up as far as possible.. Patients will be contacted by phone or letter prior to follow‐up examinations. Subjects dropping out after completion of intervention therapy will not be replaced. A final assessment visit for the relevant safety data will be always offered to the patient.