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Ajoittainen Theta-purske-stimulaatio skitsofrenian negatiivisten oireiden ja kognition parantamiseksi (ITBS-NKS-2024)

tiistai 15. syyskuuta 2026 päivittänyt: Schülke, Rasmus Dr., Hannover Medical School

Intermittirende Theta-Burst-stimulation Zur Verbesserung Von Negativsymptomatik Und Kognition Bei Skitsofrenie

The planned randomized, sham-controlled, double-blind, monocentric study aims to evaluate the effectiveness of intermittent Theta-Burst Stimulation (iTBS) on negative symptoms and cognitive deficits in schizophrenia. Both the cerebellar vermis and the left dorsolateral prefrontal cortex will be stimulated successively within the same session.

The goal of this trial is to learn if intermittent theta-burst stimulation (iTBS) of the cerebellum and the left dorsolateral prefrontal cortext (DLPFC) can treat negative symptoms and improve cognition in patients with schizophrenia. The main question it aims to answer is:

Does iTBS of the cerebellum and the left DLPFC improve negative symptoms in patients with schizophrenia? Researchers will compare iTBS to sham stimulation to see if iTBS improves negative symptoms.

Participants will:

  • Receive 10 sessions of iTBS over the course of 2 weeks
  • Undergo extensive examination before iTBS treatment, immediately after iTBS treatment and 4 weeks after iTBS treatment. The examination includes assessment of negative symptoms; psychometric assessment of cognition, social cognition, depressive symptoms; functional magnetic resonance imaging; assessment of eye movements; blood and saliva sampling; assessment of adverse events and stimulation associated sensations.

The study thus seeks to determine whether iTBS of the fronto-cerebellar network might improve negative symptoms and cognition by altering the network's functional activity. Additionally, it will investigate whether a pro-inflammatory cytokine profile could affect iTBS outcomes and whether inflammatory markers could be affected by iTBS.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

60

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

  • Saksa
    • Lower Saxony
      • Hanover, Lower Saxony, Saksa, 30625
        • Rekrytointi
        • Hannover Medical School
        • Ottaa yhteyttä:
        • Päätutkija:
          • Rasmus Schülke, MD (Dr. med.)

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 65 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

  • Diagnosis of schizophrenia (ICD-10: F20.-)
  • Age: 18-65 years
  • Ability to give informed consent
  • Signed informed consent form

Exclusion Criteria:

  • Any electronic implants
  • Non-MRI-compatible metal implants (e.g., pacemaker, cochlear implant, insulin pump, metal fragment injuries, work in the metal-processing industry)
  • Non-TMS-compatible metal implants (compatible items include: earrings, piercings, dental fillings, crowns, implants)
  • Claustrophobia
  • Epilepsy
  • History of traumatic brain injury within the last 3 months
  • History of stroke
  • Active central nervous system (CNS) infection
  • History of CNS infection within the last 3 months
  • Pregnancy
  • Current drug, medication, or alcohol abuse
  • Simultaneous participation in another clinical trial
  • Planned changes in psychopharmacological medication within the next 2 weeks
  • Severe physical illnesses that could endanger the patient, affect the examinations or make the MRI scanning cause additional burden

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: iTBS

Active intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex
Laite: Intermittent theta-burst stimulation

Intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex
Huijausvertailija: Sham iTBS

Sham intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex
Laite: Sham intermittent theta-burst stimulation

Sham intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change in negative symptoms
Aikaikkuna: From enrollment to the end of iTBS treatment

Change in negative symptoms, measured with the Clinical Assessment Interview for Negative Symptoms (CAINS). Higher CAINS scores correspond to more negative symptoms. The minimum total score is 0 points, the maximum total score is 52 points.
From enrollment to the end of iTBS treatment

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change in negative symptoms at 4-week follow-up
Aikaikkuna: From enrollment to follow-up 4 weeks after the end of iTBS treatment

Change in negative symptoms, measured with the Clinical Assessment Interview for Negative Symptoms (CAINS). Higher CAINS scores correspond to more negative symptoms. The minimum total score is 0 points, the maximum total score is 52 points.
From enrollment to follow-up 4 weeks after the end of iTBS treatment
Speech-gesture rating task
Aikaikkuna: From enrollment to the end of iTBS treatment

Accuracy and speed of evaluations in the Speech-Gesture Rating Task.
From enrollment to the end of iTBS treatment
Speech-gesture rating task at 4-week follow-up
Aikaikkuna: From enrollment to follow-up 4 weeks after the end of iTBS treatment

Accuracy and speed of evaluations in the Speech-Gesture Rating Task at 4-week follow-up.
From enrollment to follow-up 4 weeks after the end of iTBS treatment
Eye-Tracking Task
Aikaikkuna: From enrollment to the end of iTBS treatment

Changes in eye movements in the Eye-Tracking Task.
From enrollment to the end of iTBS treatment
Eye-Tracking Task at 4-week follow-up
Aikaikkuna: From enrollment to 4 weeks after the end of iTBS treatment

Changes in eye movements in the Eye-Tracking Task at 4-week follow-up.
From enrollment to 4 weeks after the end of iTBS treatment
Reading the Mind in the Eyes Test
Aikaikkuna: From enrollment to 4 weeks after the end of iTBS treatment

Reading the Mind in the Eyes Test.
From enrollment to 4 weeks after the end of iTBS treatment
Reading the Mind in the Eyes Test at 4-week follow-up
Aikaikkuna: From enrollment to 4 weeks after the end of iTBS treatment

Reading the Mind in the Eyes Test at 4-week follow-up.
From enrollment to 4 weeks after the end of iTBS treatment
N-Back Test
Aikaikkuna: From enrollment to the end of iTBS treatment

Working memory performance in the N-Back Test (sensitivity index).
From enrollment to the end of iTBS treatment
N-Back Test at 4-week follow-up
Aikaikkuna: From enrollment to the end of iTBS treatment

Working memory performance in the N-Back Test (sensitivity index) 4 weeks after the end of iTBS treatment.
From enrollment to the end of iTBS treatment
FMRI: Resting-state functional connectivity
Aikaikkuna: From enrollment to the end of iTBS treatment

Changes in resting-state functional connectivity in functional magnetic resonance imaging. Focus on connectivity between cerebellar vermis and DLPFC.
From enrollment to the end of iTBS treatment
FMRI: Resting-state functional connectivity at 4-week follow-up
Aikaikkuna: From enrollment to 4 weeks after the end of iTBS treatment

Changes in resting-state functional connectivity in functional magnetic resonance imaging. Focus on connectivity between cerebellar vermis and DLPFC.
From enrollment to 4 weeks after the end of iTBS treatment
FMRI: Task-related functional connectivity
Aikaikkuna: From enrollment to the end of iTBS treatment

Changes in task-related functional connectivity in functional magnetic resonance imaging, for the N-Back-task and the speech-gesture rating task.
From enrollment to the end of iTBS treatment
FMRI: Task-related functional connectivity at 4-week follow-up
Aikaikkuna: From enrollment to 4 weeks after the end of iTBS treatment

Changes in task-related functional connectivity in functional magnetic resonance imaging, for the N-Back-task and the speech-gesture rating task.
From enrollment to 4 weeks after the end of iTBS treatment
Inflammatory cytokines
Aikaikkuna: From enrollment to the end of iTBS treatment

Concentrations of inflammatory cytokines (especially IL-6 and TNF-α) in serum and saliva.
From enrollment to the end of iTBS treatment
Inflammatory cytokines at 4-week follow-up
Aikaikkuna: From enrollment to 4 weeks after the end of iTBS treatment

Concentrations of inflammatory cytokines (especially IL-6 and TNF-α) in serum and saliva.
From enrollment to 4 weeks after the end of iTBS treatment
Stimulation-associated perceptions
Aikaikkuna: From the beginning of each iTBS stimulation to after the end of each iTBS stimulation

Stimulation-associated perceptions, measured using the TMS Adverse Events and Associated Sensations Questionnaire (TMSensQ, Section IV), after each iTBS session.
From the beginning of each iTBS stimulation to after the end of each iTBS stimulation
Therapy dropout rate
Aikaikkuna: From the beginning of iTBS treatment to the end of iTBS treatment

Therapy dropout rate (i.e. study termination).
From the beginning of iTBS treatment to the end of iTBS treatment
Serious Adverse Events (SAEs)
Aikaikkuna: From the beginning of iTBS treatment to the end of iTBS treatment

Serious Adverse Events (SAEs), measured using TMSensQ (Section V).
From the beginning of iTBS treatment to the end of iTBS treatment
Self-reported depression: BDI-II
Aikaikkuna: From enrollment to the end of iTBS-treatment

Self-reported depression, measured using the Beck Depression Inventory-II (BDI-II). Higher scores correspond to more depressive symptoms. The minimum total score is 0 points, the maximum total score is 63 points.
From enrollment to the end of iTBS-treatment
Self-reported depression at 4-week follow-up: BDI-II
Aikaikkuna: From enrollment to 4 weeks after the end of iTBS-treatment

Self-reported depression, measured using the Beck Depression Inventory-II (BDI-II). Higher scores correspond to more depressive symptoms. The minimum total score is 0 points, the maximum total score is 63 points.
From enrollment to 4 weeks after the end of iTBS-treatment
Self-rated gesture perception and production: BAG
Aikaikkuna: From enrollment to the end of iTBS-treatment

Change in self-rated gesture perception and production, measured using the Brief Assessment of Gestures (BAG) questionnaire. Higher BAG scores correspond to greater engagement with or reliance on gestures in communication and indicate stronger tendencies to produce or perceive gestures effectively in different contexts. The minimum total score is 12 points, the maximum total score is 60 points.
From enrollment to the end of iTBS-treatment
Self-rated gesture perception and production at 4-week follow-up: BAG
Aikaikkuna: From enrollment to 4 weeks after the end of iTBS-treatment

Change in self-rated gesture perception and production, measured using the Brief Assessment of Gestures (BAG) questionnaire. Higher BAG scores correspond to greater engagement with or reliance on gestures in communication and indicate stronger tendencies to produce or perceive gestures effectively in different contexts. The minimum total score is 12 points, the maximum total score is 60 points.
From enrollment to 4 weeks after the end of iTBS-treatment
Epigenetic changes of neurotrophic and immunological factors
Aikaikkuna: From enrollment to the end of iTBS treatment

Exploratory molecular biological investigations focusing on neurotrophic (e.g., BDNF, VEGF, GDNF) and immunological (e.g., TNF-alpha, IL-6, t-PA, S100A10) factors.
From enrollment to the end of iTBS treatment
Epigenetic changes of neurotrophic and immunological factors at 4-week follow-up
Aikaikkuna: From enrollment to 4 weeks after the end of iTBS treatment

Exploratory molecular biological investigations focusing on neurotrophic (e.g., BDNF, VEGF, GDNF) and immunological (e.g., TNF-alpha, IL-6, t-PA, S100A10) factors.
From enrollment to 4 weeks after the end of iTBS treatment
Concentrations of markers of neuronal damage
Aikaikkuna: From enrollment to the end of iTBS treatment

Concentrations of markers of neuronal damage (e.g., NSE, S100-β) in serum.
From enrollment to the end of iTBS treatment
Concentrations of markers of neuronal damage at 4-week follow-up
Aikaikkuna: From enrollment to 4 weeks after the end of iTBS treatment

Concentrations of markers of neuronal damage (e.g., NSE, S100-β) in serum.
From enrollment to 4 weeks after the end of iTBS treatment

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Hannover Medical School

Tutkijat

  • Päätutkija: Rasmus Schülke, MD (Dr. med.), Hannover Medical School

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 18. syyskuuta 2026

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Viimeksi vahvistettu

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Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 11473_BO_S_2024

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

PÄÄTTÄMÄTÖN

IPD-suunnitelman kuvaus

Whether IPD may be shared has not yet been decided. IPD might not be shared due to data protection laws.

Lääke- ja laitetiedot, tutkimusasiakirjat

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Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

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Yhdysvalloissa valmistettu ja sieltä viety tuote

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Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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