Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06740747 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia

Study acronym: ITBS-NKS-2024
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 8 of 26 entries
  2. Notable Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study completion date: Jan 31, 2026 to Dec 31, 2026
    • Start date changed from estimate of Jan 2025 to Apr 8, 2025
    • Site contact updated
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  4. Notable Primary endpoint revised
    • Secondary endpoints revised (26)
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06740747
Lead Sponsor Hannover Medical School
Conditions
(from sponsor)
Schizophrenia Patients
Related terms Schizophrenia
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov