Influence of Fampridine on Working Memory in Individuals With Post COVID-19 Condition With Subjective Cognitive Impairment

• Status: Not yet recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

Summary

Pharmacological proof-of-concept study on the effects of 10 mg fampridine (twice daily oral administration during 3.5 days) on physiological processes, in particular working memory, in individuals with post COVID-19 condition.

The hypothesis ist that fampridine improves working memory performance.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Dominique de Quervain, MD
• Collaborators: Clinical Trial Unit, University Hospital Basel, Switzerland; University Hospital, Basel, Switzerland
• Treatments: 4-Aminopyridine

Criteria

Inclusion Criteria:

• male or female;

• a valid positive PCR-test for COVID-19 issued at least 3 months prior to study;

• Above medium subjective working memory impairment present at least 3 months after COVID-19 infection and lasting for at least 2 months. (The impairment must have emerged after COVID-19 infection and cannot be explained by an alternative diagnosis);

• normotensive (BP between 90/60mmHg and 140/90mmHg);

• BMI between 19 and 29,9 kg/m2;

• aged between 18 and 60 years;

• fluent German-speaking;

• IC as documented by signature.

Exclusion Criteria:

• Medical treatment of long-Covid-symptoms besides nonsteroidal noninflammatory drugs

• contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to 4-aminopyridine

• use of potassium channel blockers within the last 3 months

• concomitant treatment with OCT 2 inhibitors and -substrates (e.g. cimetidine, propranolol)

• intake of psychoactive drugs (e.g. benzodiazepines, antidepressants, neuroleptics)

• intake of oral and inhalational antihistaminics and/or steroids

• acute or chronic psychiatric disorder (e.g. major depression, psychosis, somatoform disorder, suicidal tendency)

• acute cerebrovascular condition

• history of seizures

• risk of lowered seizure threshold (due to e.g. sleep deprivation, withdrawal of alcohol after alcohol abuse)

• renal impairment

• history of malignant cancers

• walking problems (e.g. due to dizziness)

• other clinically significant concomitant disease states (e.g. hepatic dysfunction, cardiovascular disease, diabetes, asthma, urinary tract infection)

• bradycardia < 50/min during clinical examination

• clinically significant laboratory or ECG abnormality that could be a safety issue in the study

• known or suspected non-compliance (e.g. missing more than one dose of study medication per intervention phase)

• drug or alcohol abuse

• smoking (>3 cigarettes per day)

• inability to follow the procedures of the study, e.g. due to language or psychological problems of the participant

• participation in another study with an investigational drug within the 30 days preceding and during the present study

• enrolment of the investigator, his/her family members, employees and other dependent persons

• pregnancy or breast feeding

• experiencing a syncope during basal rMT measuring

• hospitalization due to COVID-19 infection.

• metal in the brain, skull or elsewhere in the body (e.g., splinters, fragments, clips, etc.)

• implanted neurostimulator (e.g., DBS, epidural/subdural, VNS)

• cardiac pacemaker or intracardiac lines

• medication infusion device

• piercings, pivot teeth (retainers are no exclusion criterion)

• tattoos (head area) less than 3 months old or older than 20 years

• condition after neurosurgery

• hearing problems or tinnitus

• not able to sit still due to tremor, tics, itching

• History of repeated syncope

• head trauma diagnosed as concussion or associated with loss of consciousness

• diagnosis of epilepsy, or a convulsion or a seizure in the past of the participant or his family

• TMS in the past showing problems

• MRI in the past showing problems

• surgical procedures to spinal cord

• spinal or ventricular derivations