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Clinical Trial

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

NCT: NCT06740747 · RECRUITING

NCT IDNCT06740747
StatusRECRUITING
Start Date2025-04-08
Completion2026-12-31
SponsorHannover Medical School (OTHER)
First posted
Last updated

Brief Summary

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.

Frequently Asked Questions

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

Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia is a clinical trial registered under NCT06740747. Current status: RECRUITING.

What is the status of NCT06740747?

The current status of NCT06740747 (Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia) is: RECRUITING.

When did Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia start?

Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia started on 2025-04-08.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.