Cranial Stimulation

Cranial Stimulation

PEP Topic 
Sleep-Wake Disturbances
Description 

Cranial electrical stimulation (CES) is a complementary medicine intervention that provides electrical stimulation to the brain. CES 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.

Effectiveness Not Established

Research Evidence Summaries

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.

doi: 10.1188/10.ONF.476-483
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Study Purpose:

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.

Intervention Characteristics/Basic Study Process:

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.

Sample Characteristics:

  • The study included 34 women aged 18 years and older (mean = 48.3 years [standard deviation (SD) = 7.9 years]).
  • All patients had breast cancer and were receiving chemotherapy.

    
 

Setting:

Multisite

Phase of Care and Clinical Applications:

 Patients were undergoing the active treatment phase of care.

Study Design:

This was a prospective, double-blind, three-group, randomized, longitudinal pilot feasibility study.

Measurement Instruments/Methods:

  • Hospital Anxiety and Depression Scale (HADS)
  • Brief Pain Inventory (BPI)–short form
  • Brief Fatigue Inventory (BFI)
  • General Sleep Disturbance Scale (GSDS)
     

Results:

Positive correlations existed between all symptoms, except pain and anxiety. Pain and fatigue symptoms were highly correlated with C-reactive protein. 

Conclusions:

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. 

Limitations:

  • Some data were missing due to the ineffectiveness of the IVR system. 
  • The study did not describe significant findings about this intervention on pain management in patients with cancer and would not be particularly valuable for the ONS Pain PEP project.
  • The study had a small sample size, with less than 100 patients.
  • No analysis of outcomes between groups was performed.

Nursing Implications:

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. 

doi: 10.1186/s40064-015-1151-z
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Study Purpose:

To examine the effects of cranial stimulation on symptoms

Intervention Characteristics/Basic Study Process:

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.

Sample Characteristics:

  • N = 163
  • MEAN AGE = 51 years (SD = 0.78 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All participants had breast cancer, and 88.3% had stage 2 disease.
  • OTHER KEY SAMPLE CHARACTERISTICS: In total, 61.7% were Caucasian, and 82% had more than a high school education.

Setting:

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Florida

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Palliative care

Study Design:

Double-blinded, randomized, sham-controlled trial

Measurement Instruments/Methods:

  • Hospital Anxiety and Depression Scale (HADS)
  • Brief Pain Inventory (BPI)
  • Brief Fatigue Inventory (BFI) 
  • General Sleep Disturbance Scale (GSDS)

Results:

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.

Conclusions:

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.

Limitations:

  • The patients had low symptom severity, which may have caused the lack of significant changes.
  • Adherence to the intervention was measured by patient self-reports.

Nursing Implications:

Cranial stimulation did not benefit symptom management in this study.

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