Safety and effectiveness of cranial electrotherapy stimulation
in treating children with emotional disorders
Funding Source, Location of Study or Author’s Affiliation
This study was conducted at the Neurorehabilitation Center, Affiliated Beijing Children’s Hospital, Capital University of Medical Sciences, Beijing, China.
The purpose of this 3-week study was to evaluate the safety and effectiveness of cranial electrotherapy stimulation (CES) for the treatment of children with emotional disorders.
This study was an open label clinical study that included 32 children who participated in a CES course of treatment.
Primary Outcome Measures
- Primary outcome 1 Anxiety symptoms reported on the Zung Self Rating Anxiety Scale (SAS)
- Primary outcome 2 Depression symptoms reported on the Zung Self Rating Depression Scale (SDS)
- Time frame: Change from Baseline in SAS and SDS scores assessed at pretest and posttest.
- The SAS and SDS is scored by summing the ratings for the 20 items. Each item is rated on a 4-point scale ranging from 1 to 4. The maximum total score is 80. A minimum score of 40 was required for inclusion in this study.
Secondary Outcome Measures
Skin temperature, blood pressure, and pulse of each subject were recorded before and after each treatment.
Key Inclusion Criteria
- Male and female children, 9-17 years old who visited doctors in the psychological clinic of Beijing Children’s Hospital.
- Diagnosis with an emotional disorder done by a physician with a specialty in child psychosis using the Chinese Classification of Mental Disorders 3 (CCMD-3) criteria, after consultation and evaluation by a psychologist.
Key Exclusion Criteria
- Use of any anxiety or depression drug therapy or participating in psychotherapy.
- Anxiety or depression state caused by schizophrenia or other physical diseases.
Evaluation with the SAS and SDS were carried out at baseline and end of treatment. The skin temperature, blood pressure, and pulse of each subject were recorded before and after each treatment. Telephone visits and regular examination at the clinic were conducted at one, three, six, and nine months after the treatment.
Device Application Protocol
The current level of the Alpha-Stim CES device was adjusted to a comfortable level for each subject, between 200 to 600 µA, and the frequency was set at 0.5 Hz. The length of treatment, 20 minutes, was also pre-set on the device. A course of treatment lasted five days, once per day.
Statistical Analysis Plan
- No apriori sample size calculations were performed.
- A repeated-measures ANOVA evaluating the within-subjects effects were used to test for differences of means between baseline and across different time points.
- Data were analyzed using t-tests and descriptive statistics.
- No formal study hypothesis was articulated, rather they were implied by the goal of statistically testing for mean reductions in the primary outcome measures.
- No missing data were reported.
- Efficacy was divided into three categories; significantly effective, effective, and ineffective.
Thirty-two children participated in the study: 15 males and 17 females. Ages ranged from 9 to 17 years with a mean of 13 years old.
Compared to baseline scores, the SAS standard score of all subjects significantly decreased and returned to a normal value (<50) after the treatment (p<0.01). Compared to baseline scores, there was a significant decrease in SDS scores at endpoint of the study (p<0.01).
Efficacy of CES
Among the 32 children, the shortest period of treatment was 3 days and the longest was 15 days with a mean of 7 days. Investigators categorized the results as significantly effective: good self-feelings, stable emotions, and good social functions, the SAS and SDS scores recovered to normal values (SAS<50, SDS<0.5). Effective: Self-feelings, emotions, social functions improved some, SAS and SDS scores decreased, but did not recover to normal values; Ineffective: No improvement in self-feelings and SAS and SDS test scores did not decrease. The total effectiveness rate was 94%; Significantly effective – 40.62%, Effective – 53.12%, Ineffective – 0.062%.sychiatry. 1965 Dec;13(6):508-15.
Decrease in anxiety scores
Decrease in depression scores
Physiological indices before and after CES treatment
Skin temperature increased significantly after treatment from baseline (p<0.01). There was a significant decrease in systolic blood pressure and pulse rate (p<0.05). These significant changes occurred in 75% of all subjects.
Twenty-six (26) cases among the 32 participants were followed up (follow-up rate: 81%), of which 24 cases had long lasting efficacy with relieved or eliminated symptoms, and two cases had insignificant efficacy without significant emotional improvement and with relapse of symptoms. Medications were needed to control the symptoms for these two participants.
Safety Outcome Measures
The subject’s compliance was good; they did not have significant discomfort during or after the treatment; and there were no adverse events. During the treatment, three subjects occasionally felt dizziness and local irritation, but the symptoms were minor; as the treatment continued, these symptoms could be relieved or eliminated. All subjects completed the treatment in the prescribed period.
In this study, it was observed that most children with emotional disorders (75%) had changes in physiological indices after CES treatment. Such changes include a rise of skin temperature and drop in blood pressure and pulse. Such changes indicate the parasympathetic nervous system got excited, which led to peripheral vasodilation, and the organism generated warm, relaxed, and comfortable feelings. The changes in emotions were fast and significant, turning significantly better 3-5 days or 7-10 days after treatment. Of the 26 cases that completed follow-up, 24 had long lasting efficacy with relieved or eliminated symptoms.
The authors conclude that, compared with the traditional psychotherapy and pure drug therapy, treatment with CES can get rid of the disadvantages of pure psychotherapy such as long course, slow effect and easy missing, and also the disadvantages of pure drug therapy such as big influence on children in the stage of growth and development, unavoidable toxic and side effects and poor adherence to drug use of children. It can also be taken as another effective and safe psychological therapy technique apart from the traditional psychotherapy and pure drug therapy.
Limitations include variation in the number of CES treatments. While it is expected that some children may miss a CES treatment, some children had more than the number of CES treatments (5) in the protocol. The small sample size is also a limitation of the study. The positive findings of this study are consistent with other studies on anxiety and depression that used Alpha-Stim CES technology.
Study Quality: GOOD