Accelerated, Neuronavigated Neuromodulation for Negative Symptoms in Schizophrenia: Protocol for a Randomized...

Area of Science:

• Neuroscience
• Psychiatry
• Clinical Trials

Background:

• Negative symptoms (NS) in schizophrenia lead to significant functional impairment with limited treatment options.
• Repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex (LDLPFC) shows modest efficacy for NS.
• Accelerated protocols, like five-day intermittent theta burst stimulation (iTBS), have shown rapid effects in depression.

Purpose of the Study:

• To evaluate the feasibility, safety, and preliminary efficacy of a five-day, high-dose, fMRI-guided neuronavigated iTBS protocol for NS in schizophrenia.
• To compare neuronavigated iTBS with non-neuronavigated iTBS and sham stimulation.
• To assess changes in social/affective processing and depressive symptoms.

Main Methods:

• Multisite, randomized, patient- and rater-blinded trial with 75 adults with schizophrenia spectrum disorders.
• Three arms: (1) neuronavigated active iTBS, (2) non-neuronavigated active iTBS, (3) neuronavigated sham stimulation.
• 10 daily sessions over 5 consecutive days, with follow-ups at 1 week, 1 month, and 3 months.

Main Results:

• Primary outcome: reduction in negative symptoms.
• Secondary outcomes: efficacy comparison of targeting strategies, feasibility, safety, social/affective processing, and depressive symptoms.
• Data will inform future clinical trials and clarify the utility of neuronavigation.

Conclusions:

• This trial investigates a time-efficient, personalized intervention for negative symptoms in schizophrenia.
• Results will guide future research and potentially offer a novel treatment for NS.
• Comparison of targeting methods will determine the value of neuronavigation in iTBS for schizophrenia.