Therapeutic efficacy of acupuncture on motor dysfunction in ischemic stroke patients with hemiplegia and its EEG characteristics: protocol for a randomized, sham-acupuncture controlled, assessor-and-statistician-blinded trial.

Stroke is one of the leading causes of death and disability worldwide, and when it strikes, it often leaves survivors struggling with weakness or paralysis on one side of the body — a condition called hemiplegia. Recovering movement after a stroke is one of the biggest challenges patients and their families face, and finding effective therapies during the early recovery window is critical.

A new clinical trial is now underway to find out whether a specific style of acupuncture can meaningfully improve limb function in people recovering from ischemic stroke. Ischemic stroke — the most common type, accounting for over 80% of all strokes — occurs when a blood clot blocks blood flow to part of the brain.

The study is enrolling 70 patients who are in the recovery stage of ischemic stroke and have limb dysfunction. Half will receive real acupuncture treatments designed according to Traditional Chinese Medicine (TCM) principles that address both "phlegm" and "blood stasis" — two core patterns TCM associates with stroke. The other half will receive sham acupuncture, which mimics the treatment without the same needle stimulation. Neither the outcome assessors nor the statisticians will know which patients received which treatment, keeping the results unbiased.

The trial runs for two weeks and measures improvement in arm and leg movement using validated scales like the modified Fugl-Meyer scale. Researchers are also using EEG brain wave monitoring to track how acupuncture may affect brain activity and connectivity — giving them a window into the neurological mechanisms behind any recovery they observe.

While this is a protocol study — meaning the trial design is being published before results are available — it represents a rigorous effort to build the evidence base for acupuncture in stroke rehabilitation.

If you or a loved one is recovering from stroke and interested in acupuncture, speak with a licensed acupuncturist who has experience working with neurological conditions.

This registered single-center RCT (ITMCTR2025001171) aims to evaluate a TCM-based acupuncture protocol targeting simultaneous resolution of phlegm and blood stasis in ischemic stroke patients with hemiplegia during the recovery stage. A total of 70 participants will be randomized 1:1 to verum acupuncture or sham acupuncture control over a 2-week treatment course. The primary outcome is change in modified Fugl-Meyer Assessment (motor function); secondary outcomes include Berg Balance Scale, Fugl-Meyer Sensory Function, Modified Ashworth Score, Barthel Index, and TCM syndrome scores. A notable methodological feature is the incorporation of EEG to assess cortical neuronal excitability and inter-regional functional connectivity, with the intent to identify predictive electrophysiological biomarkers. Assessor and statistician blinding are employed to minimize performance and detection bias. No effect size data are yet available as this is a protocol publication. This trial may yield high-quality evidence supporting acupoint combination strategies rooted in TCM pathophysiology for post-stroke neurological rehabilitation.