Does repetitive transcranial magnetic stimulation (= a non-invasive method of brain stimulation) help alleviate depressive symptoms associated with an infection?
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
post-infectious depressive symptoms
(BASEC)
• Age between 18 and 65 years • Presence of affective symptoms for more than 12 weeks after an infection (BASEC)
Criteri di esclusione
• 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)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Flurin Cathomas
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Flurin Cathomas
058 384 34 35
flurin.cathomas@clutterpukzh.chPsychiatrische Universitätsklinik Zürich
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
29.10.2024
(BASEC)
ID di studio ICTRP
NCT06716996 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Repeated transcranial magnetic stimulation for the treatment of post-infectious affective symptoms (BASEC)
Titolo accademico
Repeated Transcranial Magnetic Stimulation for the Treatment of Post-COVID Associated Affective Symptoms (ICTRP)
Titolo pubblico
RTMS for the Treatment of Post-COVID Associated Affective Symptoms (ICTRP)
Malattie studiate
Post COVID -19 Depression (ICTRP)
Intervento studiato
Device: repeated transcranial magnetic stimulation;Device: sham treatment (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
Depression severity (ICTRP)
Individual symptom dimensions and levels of functioning/quality of life.;Immune markers (ICTRP)
Data di registrazione
27.11.2024 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
University of Zurich (ICTRP)
Contatti aggiuntivi
Flurin Cathomas, PD Dr. med.;Flurin Cathomas, PD Dr. med., flurin.cathomas@pukzh.ch, +41583843435;+41583843435 (ICTRP)
ID secondari
TMS-CO (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06716996 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile