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Prefrontal Transcranial Pulse Stimulation for Major Depressive Disorder: A Randomized Clinical Trial.

Penny Ping Qin¹, Minxia Jin^1,2, Rebecca Laidi Kan¹

¹Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.

JAMA Network Open

|July 6, 2026

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This summary is machine-generated.

Transcranial pulse stimulation (TPS) demonstrated antidepressant effects in a randomized clinical trial for major depressive disorder. This novel noninvasive brain stimulation technique showed significant improvements and modulated brain circuits, suggesting therapeutic potential.

Area of Science:

Neuroscience
Psychiatry
Medical Technology

Background:

Transcranial pulse stimulation (TPS) is an emerging noninvasive brain stimulation technique.
Preliminary evidence suggests TPS may have antidepressant effects.
However, rigorous testing in double-blind, sham-controlled randomized clinical trials was lacking.

Purpose of the Study:

To evaluate the antidepressant efficacy of TPS in patients diagnosed with major depressive disorder (MDD).

Main Methods:

A 2-arm, parallel-design, double-blind, sham-controlled randomized clinical trial was conducted.
Eighty participants with MDD (Hamilton Depression Rating Scale score ≥14) were randomized to receive 12 sessions of active or sham TPS targeting the left dorsolateral prefrontal cortex.
The primary outcome measure was the change in Montgomery-Åsberg Depression Rating Scale (MADRS) score after 12 sessions.

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Main Results:

The active TPS group showed a statistically significant greater reduction in MADRS scores compared to the sham group (mean difference: -4.19, P=.048).
Resting-state fMRI revealed that active TPS significantly enhanced functional connectivity within the left dorsolateral prefrontal cortex and its connections with other brain regions implicated in depression.
The treatment was found to be safe and well-tolerated.

Conclusions:

Transcranial pulse stimulation is a safe and well-tolerated treatment for major depressive disorder.
TPS demonstrates antidepressant effects and modulates key brain circuits involved in depression.
Further research is warranted to optimize TPS efficacy through increased sessions and refined targeting.