JAMA network open · 2026
Prefrontal Transcranial Pulse Stimulation for Major Depressive Disorder: A Randomized Clinical Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Qin Penny Ping, Jin Minxia, Kan Rebecca Laidi, Chak Ivan, Zhang Bella Bingbing, Chau Wanda, Li Ami, Lin Tim Tianze, Xia Adam Weili, Wang Sharie Xiao, Yuan Tifei, Cheung Teris, Beisteiner Roland, Sun Lei, Padberg Frank, Kranz Georg S
Аннотация
IMPORTANCE: Transcranial pulse stimulation is a novel noninvasive brain stimulation technique with preliminary evidence of antidepressant effects; however, its efficacy has not been tested in a double-blind, sham-controlled randomized clinical trial.
OBJECTIVE: To examine the antidepressant efficacy of transcranial pulse stimulation for major depressive disorder.
DESIGN, SETTING, AND PARTICIPANTS: This 2-arm, parallel-design, double-blind, sham-controlled randomized clinical trial was conducted between June 1, 2023, and October 31, 2025, at the Hong Kong Polytechnic University. Patients with major depressive disorder and a Hamilton Depression Rating Scale score of 14 or higher were convenience sampled and enrolled.
INTERVENTIONS: Participants were randomized 1:1 to receive 12 sessions (1000 pulses per session) of active or sham transcranial pulse stimulation targeting the left dorsolateral prefrontal cortex during 4 weeks.
MAIN OUTCOMES AND MEASURES: Change in Montgomery-Åsberg Depression Rating Scale score (range, 0 [no depression] to 60 [severe depression], with a change of at least 6 indicating minimal change and 12 or more indicating substantial change) after 12 treatment sessions.
RESULTS: This modified intention-to-treat analysis included 80 participants (mean [SD] age, 35.6 [11.7] years; mean [SD] years of education, 15.5 [3.3]; 53 females), with 74 completing treatment and 6 withdrawing (2 from sham due to adverse effects); 40 participants were randomized to the active group and 40 to the sham group. The active group demonstrated a statistically significantly greater reduction in Montgomery-Åsberg Depression Rating Scale scores than the sham group (mean difference, -4.19; 95% CI, -8.33 to -0.04; P = .048; Hedges g = 0.45). Resting-state functional magnetic resonance imaging analyses found that, compared with the sham stimulation, active stimulation significantly enhanced functional connectivity within the left dorsolateral prefrontal cortex (mean difference, 0.11; 95% CI, 0.03-0.19; P = .009); between the left dorsolateral prefrontal cortex and left orbitofrontal, superior medial prefrontal, and pregenual anterior cingulate cortices (mean difference, 0.11; 95% CI, 0.05-0.17; P < .001); and between the left dorsolateral prefrontal cortex and posterior cingulate cortex and bilateral precuneus and calcarine cortex (mean difference, 0.08; 95% CI, 0.01-0.16; P = .02).
CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of transcranial pulse stimulation, the treatment was safe, well tolerated, and associated with antidepressant effects and modulation of multiple depression-relevant brain circuits. These findings provide a rationale for future studies to optimize therapeutic efficacy by increasing the number of treatment sessions and refining targeting strategies.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05551585.
OBJECTIVE: To examine the antidepressant efficacy of transcranial pulse stimulation for major depressive disorder.
DESIGN, SETTING, AND PARTICIPANTS: This 2-arm, parallel-design, double-blind, sham-controlled randomized clinical trial was conducted between June 1, 2023, and October 31, 2025, at the Hong Kong Polytechnic University. Patients with major depressive disorder and a Hamilton Depression Rating Scale score of 14 or higher were convenience sampled and enrolled.
INTERVENTIONS: Participants were randomized 1:1 to receive 12 sessions (1000 pulses per session) of active or sham transcranial pulse stimulation targeting the left dorsolateral prefrontal cortex during 4 weeks.
MAIN OUTCOMES AND MEASURES: Change in Montgomery-Åsberg Depression Rating Scale score (range, 0 [no depression] to 60 [severe depression], with a change of at least 6 indicating minimal change and 12 or more indicating substantial change) after 12 treatment sessions.
RESULTS: This modified intention-to-treat analysis included 80 participants (mean [SD] age, 35.6 [11.7] years; mean [SD] years of education, 15.5 [3.3]; 53 females), with 74 completing treatment and 6 withdrawing (2 from sham due to adverse effects); 40 participants were randomized to the active group and 40 to the sham group. The active group demonstrated a statistically significantly greater reduction in Montgomery-Åsberg Depression Rating Scale scores than the sham group (mean difference, -4.19; 95% CI, -8.33 to -0.04; P = .048; Hedges g = 0.45). Resting-state functional magnetic resonance imaging analyses found that, compared with the sham stimulation, active stimulation significantly enhanced functional connectivity within the left dorsolateral prefrontal cortex (mean difference, 0.11; 95% CI, 0.03-0.19; P = .009); between the left dorsolateral prefrontal cortex and left orbitofrontal, superior medial prefrontal, and pregenual anterior cingulate cortices (mean difference, 0.11; 95% CI, 0.05-0.17; P < .001); and between the left dorsolateral prefrontal cortex and posterior cingulate cortex and bilateral precuneus and calcarine cortex (mean difference, 0.08; 95% CI, 0.01-0.16; P = .02).
CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of transcranial pulse stimulation, the treatment was safe, well tolerated, and associated with antidepressant effects and modulation of multiple depression-relevant brain circuits. These findings provide a rationale for future studies to optimize therapeutic efficacy by increasing the number of treatment sessions and refining targeting strategies.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05551585.