Cranial stimulation is a complementary medicine intervention that provides electrical stimulation to the brain. Cranial electrical stimulation studied in patients with cancer was delivered via a medical device that delivered a programmed level of electrical stimulation via electrodes attached to the earlobes with a low intensity delivered from a battery source. This intervention was studied in patients with cancer for its effect on fatigue and sleep/wake disturbance.
Lyon, D. E., Schubert, C., & Taylor, A. G. (2010). Pilot study of cranial stimulation for symptom management in breast cancer. Oncology Nursing Forum, 37, 476–483.
To determine whether cranial electrical stimulation (CES) is feasible for symptom management in patients with breast cancer receiving chemotherapy and to examine the outcomes for reducing the symptoms of fatigue, depression, anxiety, pain, and sleep disturbances in these patients.
Symptom reports (on fatigue, depression, anxiety, pain, and sleep disturbances) were collected at baseline by a research associate and then weekly using an interactive voice response (IVR) phone system. Patients were trained on the use of the CES devices and were able to use them at a setting of 100 µA for up to sixty minutes per day. They began using the devices on the first day of their chemotherapy infusions. Patients receiving chemotherapy every two weeks used the CES device for a total of six weeks; those receiving chemotherapy every three weeks used them for a total of eight weeks. A follow-up interview was held after patients finished the protocol.
Multisite
Patients were undergoing the active treatment phase of care.
This was a prospective, double-blind, three-group, randomized, longitudinal pilot feasibility study.
Positive correlations existed between all symptoms, except pain and anxiety. Pain and fatigue symptoms were highly correlated with C-reactive protein.
CES appears to be a safe intervention during chemotherapy. This study showed that CES was a feasible and safe intervention during chemotherapy. It also showed positive correlations between several symptom management variables, but larger studies are needed to determine whether CES is effective for symptom management.
The study examined several symptoms seen in patients with breast cancer. Larger studies are needed to examine whether CES has a true effect on pain symptoms in patients with breast cancer.
Lyon, D., Kelly, D., Walter, J., Bear, H., Thacker, L., & Elswick, R.K. (2015). Randomized sham controlled trial of cranial microcurrent stimulation for symptoms of depression, anxiety, pain, fatigue and sleep disturbances in women receiving chemotherapy for early-stage breast cancer. Springerplus, 4, 369-015-1151-z.
To examine the effects of cranial stimulation on symptoms
Women were randomly assigned to receive actual or sham cranial stimulation. The device passed biphasic electrical stimulation via ear lobe electrodes. The active device was preset to deliver maximum stimulation at 0.5 Hz and 100 µA, the lowest setting below the level of perception. The sham device was identical but did not transmit a current. Patients were instructed to use the device daily for one hour during chemotherapy treatment and for two weeks after treatment cessation. Symptom data were collected weekly, and patients completed logs to record stimulator use.
Double-blinded, randomized, sham-controlled trial
There were no statistically significant differences in levels of depression, anxiety, pain, fatigue, or sleep at any time point during the study. Symptom levels were low. Anxiety was highest at baseline and decreased over time. Depression and fatigue increased over time.
This study did not demonstrate any benefit of microcurrent cranial stimulation in the management of pain, anxiety, depression, fatigue, or sleep disturbance among women receiving chemotherapy for breast cancer.
Cranial stimulation did not benefit symptom management in this study.