Original Article Clinical Effects of Scalp Electrical Acupuncture in Stroke: A Sham-Controlled Randomized Clinical Trial Wu Tu Hsing, MD, PhD, 1 Marta Imamura, MD, PhD, 2 Kayleen Weaver, BA, 3 Felipe Fregni, MD, PhD, 3,4 and Raymundo S. Azevedo Neto, MD, PhD 1 Abstract Objectives: The majority of individuals who survive a stroke are disabled because of persisting neurological impairments. The objective of this study was to evaluate the efficacy of subcutaneous electrical stimulation of the scalp in spontaneous functional recovery of patients with chronic ischemic stroke, by evaluating clinical, neu- rological, and functional findings. Subjects and methods: Sixty-two (62) subjects who were at least 18 months postdiagnosis of ischemic stroke were randomized to receive 10 sessions of placebo or active low-frequency electrical stimulation (2/100 Hz) using subcutaneous acupuncture needles over the scalp. Functional and neurological evaluations were indexed by the Barthel, Rankin, and National Institutes of Health Stroke Scale (NIHSS). Results: Results show that there was a significant difference in functional improvement between the sham and active group as indexed by NIHSS scale. The active group had a larger functional improvement after 10 sessions of scalp electrical acupuncture. The other two functional scales (Rankin and Barthel) failed to show significant differences between the two treatment groups. Conclusions: These results support further testing of scalp electrical acupuncture for the treatment of stroke as well further mechanistic studies to understand mechanisms associated with the observed improvement. Further studies need to consider longer follow-up assessments to investigate potential functional changes associated with electrical acupuncture. Introduction A mong all disabling entities, stroke plays an impor- tant role in means of number of involved patients and impact on health services. Despite the high incidence and resultant sequelae, there are still few treatment alternatives for these patients during the chronic stage to recover motor and other cognitive functions. Spontaneous recovery using stan- dard rehabilitation procedures can be achieved up to on av- erage 6 months to 1 year after the initial ictus. In fact, about one third to half of patients remain with moderate to severe functional deficits. 1 Aside from traditional forms of physical therapy, alter- native forms of rehabilitation, such as acupuncture, may be beneficial in promoting long-term spontaneous recovery in patients who have had a stroke. Scalp acupuncture appears to be an innovative therapeutic method capable of treating cerebral or visceral diseases related to the cerebral cortex. This method consists of the introduction of needles in the subcutaneous tissue of the scalp at corresponding functional areas of the cerebral cortex. 2 Various studies have shown the possibility of clinical and functional improvement in ischemic stroke using nonscalp acupuncture techniques, 3,4 though evidence is mixed and a recent review concluded that there was not enough evidence supporting the effects of acupuncture for acute and subacute stroke. 5 On the other hand, other authors have evaluated the efficacy of electroacupuncture for treatment of stroke se- quelae and showed some beneficial results. 6 Naeser et al. (1994) compared manual acupuncture’s effect associated with electroacupuncture with a control group for the treat- ment of paralysis in patients who have had an acute stroke and who are undergoing physiotherapy. 6 As results are still mixed and there are no definite answers on the effects of electroacupuncture for chronic stroke, a sham-controlled randomized trial was conducted to evaluate 1 Department of Pathology, University of Sa ˜ o Paulo School of Medicine, Sa ˜ o Paulo, Brazil. 2 Division of Physical Medicine, Institute of Orthopaedics and Traumatology, University of Sa ˜ o Paulo School of Medicine, Sa ˜ o Paulo, Brazil. 3 Laboratory of Neuromodulation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA. 4 Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA. THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE Volume 18, Number 4, 2012, pp. 1–6 ª Mary Ann Liebert, Inc. DOI: 10.1089/acm.2011.0131 1