Focus of the Report: The focus of this Health Technology Assessment (HTA) is to evaluate the effectiveness and safety of theta burst stimulation (TBS), alone and compared with repetitive transcranial magnetic stimulation (rTMS) and/or with sham TBS, for the management of treatment-resistant major depressive disorder (MDD) (unipolar treatment-resistant depression [TRD]) in adult patients.

Technology Description: rTMS is a noninvasive technique that utilizes an electromagnetic coil placed over the scalp to stimulate targeted regions of the brain that are believed to contribute to MDD. TBS is a variation of rTMS that delivers short bursts of pulses at specific intervals in order to mimic the frequency of natural neural activity. A typical session of TBS takes approximately 3 minutes to complete, whereas a standard session of rTMS takes approximately 40 minutes.

Controversy: rTMS is an efficacious treatment that has proven reliability and safety and is often considered a first-line intervention for the management of TRD. Although TBS is a variant of TMS that leverages similar methodology with the benefit of employing far shorter treatment sessions, it is unclear whether TBS can achieve the same efficacy as rTMS for alleviating depression symptoms. Additionally, it has been postulated that TBS could lead to a higher incidence of treatment-related seizures. Finally, there are outstanding questions concerning whether certain patient and disease characteristics are associated with better or worse outcomes, what the trajectory of response to TBS is, and whether the efficacy of TBS varies by technique or coil placement.

Key Questions:

  1. Is TBS effective for the management of treatment-resistant MDD (unipolar TRD) in adults?

  2. How does TBS compare with clinical alternatives for the treatment of unipolar TRD in adults?

  3. Is TBS in adult patients with unipolar TRD safe?

  4. Have definitive patient selection criteria been identified for TBS for treating unipolar TRD in adults?

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