Percutaneous mastoid electrical stimulator alleviates autonomic dysfunction in patients with acute ischemic stroke

ABSTRACT

Background and Purpose: Poststroke prognosis is associated with autonomic status. The purpose of our study was to determine whether percutaneous mastoid electrical stimulator (PMES) can alleviate abnormal heart rate variability (HRV) and improve clinical outcome.

Methods: This prospective, randomized, double-blinded, placebo-controlled study enrolled a total of 140 patients with autonomic dysfunction within 3d after acute ischemic stroke. The patients were treated with PMES or sham stimulation once daily over a period of 2 weeks. HRV was primarily assessed by the fractal dimension (FD) at admission and 2 weeks. All patients were followed up for 3 months. The clinical outcome was death and major disability (modified Rankin Scale score≥ 3) at 3 months after acute ischemic stroke.

Results: FD of the 2-week treatment period increased in PMES groups. PMES can significantly alleviate abnormal HRV. The difference in FD of the 2-week treatment period between the PMES and sham groups was significant (1.14 ± 0.27 vs. 1.00 ± 0.23; P = 0.001). In fully adjusted models, PMES was associated with reduced 3-month mortality (adjusted odds ratio, 0.32; 95% confidence interval, 0.11–0.93; P = 0.036). No significant group differences were seen in three major disability and composite outcome (P > 0.05).

Conclusions: PMES was a safe, effective, and low-cost therapy to alleviate HRV and could significantly reduce mortality in the early recovery phase after acute ischemic stroke.

KEYWORDS:

• Acute ischemic stroke
• fractal dimension
• percutaneous mastoid electrical stimulator
• treatment

Acknowledgments

The devices were provided by Chongqing Haikun Medical Instrument Co., Ltd. None of the investigators has any financial interest in Chongqing Haikun Medical Instrument Co., Ltd.

Availability of data and materials

Data used in this study may be available by request to corresponding author via email: [email protected]

Ethics approval and consent to participate

We obtained ethical approval for this study from the Medical and Health Research Ethics Committee at Second people’s Hospital of Chengdu. Written informed consent was obtained from all study participants or their legal proxies (516).

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This work was funded by the Health and Family Planning Commission of Chengdu (2015009).

Notes on contributors

Lanying He

Lanying He, M.D., Associate Chief of Neurology, was responsible for the concept and design of the study, data collection and analysis and the first draft of the paper and further manuscript.

Jian Wang

Jian Wang, M.D., Chief of Neurology, was responsible for the design of the study.

Ya Liu

Ya Liu, M.D., Chief of Geriatrics was responsible for concept and design of the study, the data analysis, and interpretation.

Weiwei Dong

Weiwei Dong, M.D., Chief of Neurology, was responsible for the interpretation.

Hao Yang

Hao Yang, M.D., Chief of Electrical Engineering, was responsible for design software of FD in off-line compute.

Yong Luo

Yong Luo, M.D., Professor of Neurology, was responsible for overseeing the concept and design of the study.

Tao Xiang

Tao Xiang, M.D., Associate Chief of Rehabilitation, was responsible for data collection.

Lun Luo

Lun Luo, M.D., Chief of Rehabilitation, was responsible for the data collection.

All authors read and approved the final manuscript for publication.