Does repetitive transcranial magnetic stimulation (= a non-invasive method of brain stimulation) help alleviate depressive symptoms associated with an infection?
Zusammenfassung der Studie
SARS-CoV-2 and other infections (such as infections with certain herpes viruses) have been shown to lead to depressive symptoms. Currently, there is no standard treatment that alleviates both the depressive symptoms and has an anti-inflammatory effect, making research into new treatment approaches extremely important. In this study, we investigate whether the intervention method of repetitive transcranial magnetic stimulation (= a non-invasive method of brain stimulation, rTMS) can alleviate affective symptoms that have developed after an infection. If you choose to participate, you will be randomly assigned to one of two groups. You will either belong to the experimental group or the control group. You will not know which group you belong to. In the experimental group, you will be treated with the intervention method of repetitive transcranial magnetic stimulation. In the control group, you will receive a placebo treatment. Your participation in this study will last for 10-13 weeks.
(BASEC)
Untersuchte Intervention
In this project, we want to investigate whether repetitive transcranial magnetic stimulation (rTMS) can alleviate affective symptoms that have occurred after an infection. Additionally, we are interested in how rTMS can change the immune system and how these changes are related to the affective symptoms. Numerous studies have demonstrated that rTMS is an effective and safe method for alleviating depressive symptoms, which is why this procedure is already used daily in clinical practice. However, the underlying mechanism is not yet fully understood. Recent studies have also shown that rTMS can influence the autonomic nervous system. Due to the close interplay between the immune system and the autonomic nervous system, it is expected that rTMS also has an impact on our immune system. The 52 participants will be randomly divided into two groups of 26 participants each. The first group will undergo a series of rTMS treatments. The second group will serve as a control group and will receive placebo treatments.
(BASEC)
Untersuchte Krankheit(en)
post-infectious depressive symptoms
(BASEC)
• Age between 18 and 65 years • Presence of affective symptoms for more than 12 weeks after an infection (BASEC)
Ausschlusskriterien
• No psychiatric pre-existing conditions before the infection • No change in antidepressant medication for at least 3 months prior to study inclusion • No severe somatic comorbidities or substance use disorders (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
Flurin Cathomas
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Flurin Cathomas
058 384 34 35
flurin.cathomas@clutterpukzh.chPsychiatrische Universitätsklinik Zürich
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
29.10.2024
(BASEC)
ICTRP Studien-ID
NCT06716996 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Repeated transcranial magnetic stimulation for the treatment of post-infectious affective symptoms (BASEC)
Wissenschaftlicher Titel
Repeated Transcranial Magnetic Stimulation for the Treatment of Post-COVID Associated Affective Symptoms (ICTRP)
Öffentlicher Titel
RTMS for the Treatment of Post-COVID Associated Affective Symptoms (ICTRP)
Untersuchte Krankheit(en)
Post COVID -19 Depression (ICTRP)
Untersuchte Intervention
Device: repeated transcranial magnetic stimulation;Device: sham treatment (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Gender: All
Maximum age: 65 Years
Minimum age: 18 Years
Inclusion:
- Informed Consent as documented by signature
- Age between 18-65 years
- Proof of past COVID-19 infection by polymerase chain reaction (PCR) test or serology
- Negative COVID- 19 PCR test at the time of inclusion
- Affective symptoms (= 15 points on the Montgomery- ?sberg Depression Rating Scale)
lasting for more than 12 weeks since COVID-19 infection
- No psychiatric history prior to the COVID-19 infection
- No major somatic comorbidities or substance use disorder
Exclusion:
- Contraindications to the rTMS treatment e.g. cochlear implants and metallic devices
close to the TMS coil, a history of strokes, head injuries or seizures/epilepsy
- Epileptiform potentials in the electroencephalogram (EEG)
- Previous rTMS prior to the study
- Known severe hypersensitivity or severe adverse reaction to rTMS
- Women who are pregnant or breastfeeding
- Intention to become pregnant during the course of the study
- Psychiatric history prior to the COVID-19 infection
- Major somatic comorbidities e.g. renal failure, hepatic dysfunction, heart failure,
cardiovascular disease.
- If the participant took antidepressants before the beginning of the study, there
needs to be a washout period. The antidepressant has to be stopped for at least 3
weeks before commencing the study.
- The following drugs are not allowed during the study: any antidepressants, any
antipsychotics, any drugs that lower the seizure threshold
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems
- Participation in another study with investigational treatment within the 30 days
preceding and during the present study
- Enrolment of the investigator, his/her family members, employees and other dependent
persons (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Depression severity (ICTRP)
Individual symptom dimensions and levels of functioning/quality of life.;Immune markers (ICTRP)
Registrierungsdatum
27.11.2024 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
University of Zurich (ICTRP)
Weitere Kontakte
Flurin Cathomas, PD Dr. med.;Flurin Cathomas, PD Dr. med., flurin.cathomas@pukzh.ch, +41583843435;+41583843435 (ICTRP)
Sekundäre IDs
TMS-CO (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06716996 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar