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Twice-daily neuronavigated intermittent theta burst stimulation for bipolar depression: A Randomized Sham-Controlled
Samuel Bulteau1, Lysianne Beynel2, Christian Marendaz3
1Clinical Investigation Unit "Behavioral Addictions/Complex Affective Disorders", Addictology and Psychiatry Department, CHU de Nantes, 44000 Nantes, France; Inserm U1246, MethodS in Patients-centered outcomes and HEalth Research, University of Nantes, 44000 Nantes, France.
Neuronavigated intermittent theta burst stimulation (iTBS) appears safe for bipolar depression. Active iTBS showed promising response and remission rates, though not significantly different from sham in this initial study.
Area of Science:
- Neuroscience
- Psychiatry
- Neuromodulation
Background:
- Bipolar depression lacks effective treatments.
- Neuronavigated intermittent theta burst stimulation (iTBS) is a novel neuromodulation technique.
- The efficacy of iTBS for bipolar depression is unstudied.
Purpose of the Study:
- To investigate the safety and efficacy of neuronavigated iTBS in bipolar depression.
- To hypothesize the superiority of active iTBS over sham stimulation.
Main Methods:
- Twenty-six patients with bipolar depression were randomly assigned to active (n=12) or sham (n=14) iTBS.
- Treatment involved twice-daily iTBS sessions.
- Depression severity was assessed using the MADRS scale.
Main Results:
- Active iTBS showed high response (72%) and remission (42%) rates.
- Sham stimulation yielded response (42%) and remission (25%) rates.
- No significant difference in outcomes was observed between active and sham iTBS.
- No adverse events were reported, indicating good tolerability.
Conclusions:
- Twice-daily iTBS is safe and well-tolerated in patients with bipolar depression.
- Larger controlled studies are needed to confirm iTBS superiority for treatment-resistant bipolar depression.
