A novel medical device that relieves anxiety, depression and pain while improving sleep in a population of teachers

Kirsch TB, Kuhn J, Price LR, Marksberry J, Haltiwanger SG. A novel medical device that relieves anxiety, depression and pain while improving sleep in a population of teachers. Journal of Depression and Anxiety, 2019; 8:334.

Device
Alpha-Stim®

Key Variables
Anxiety, insomnia, depression, and pain

Objective

This study was conducted to confirm the benefits of Alpha-Stim® cranial electrotherapy stimulation (CES) technology as an effective non-drug treatment for anxiety, mood, sleep, and pain in teachers following a successful pilot study at the Leigh Academy, Dartford, United Kingdom. The second objective was to determine whether a new Alpha-Stim smartphone app was a reliable method of evaluating the effectiveness of using the device to treat anxiety, insomnia, depression and pain.

Design

Thirty-five teachers (29 females and 6 males) in the Mineral Wells, Texas Independent School District, volunteered to participate in a study to reduce anxiety, depression, insomnia, and pain by passing a mild electric current with specific waveform characteristics through their brains via electrodes that clip on their ears. It was a six-week open-label design where participants tracked their progress using a new smartphone app to record their symptoms at least five days per week. The subjects were encouraged to use the device for 20-60 minutes any time of day and for any indication.

Primary Effectiveness Endpoint

This study was conducted to confirm the benefits of Alpha-Stim CES technology as an effective non-drug treatment for anxiety, mood, sleep, and pain in teachers.

Secondary Outcome Measures

The second purpose of this study was to examine the effectiveness of monitoring Alpha-Stim CES treatment using a smartphone application. Outcome measures were pre-post scores used in monitoring anxiety, depression, insomnia, pain and stress in a sample of teachers.

Key Inclusion Criteria

  • Participants were required to provide informed written and oral consent for the study.
  • Not suffering from any major mental illness or health disorder.

Key Exclusion Criteria

  • Excluded was a diagnosis of any other mental disorder g., sub-stance use disorder, eating disorder, bipolar disorder, non-affective psychosis.
  • Pregnancy
  • Implantation with a pacemaker or an implantable cardioverter device (ICD).

Protocol Summary

Participants were instructed to use the Alpha-Stim in the usual manner, at a comfortable current level for 20-60 minutes daily. The frequency of the waveform was constant at 0.5 Hz, and the current was adjustable from 100 – 600 microamps. At pretest (baseline) and posttest, data on outcome measures were recorded as perceived levels of discomfort specific to the teachers’ anxiety, depression, insomnia, and pain. The study was conducted for six weeks with a smartphone app, during which time they monitored themselves at least five days per week. Participants were permitted to use the device anytime of day and for any indication. At the end of six weeks, they were asked to complete a survey of perceived effectiveness. The smartphone application used by subjects for reporting their perceived level of insomnia, pain, anxiety, depression, and stress includes an 11-point scale representing a continuous level of measurement expressed as values of 0 – 10. A value of zero (0) signified the absence of any symptoms and a value of ten (10) signified a very high level of discomfort as perceived by the participants.

Results

Baseline Measurements
Baseline measurements were taken prior to starting the six-week study.

Data Analysis
Data were analyzed using the student t-test (unpaired) comparing pre and posttest measurements. The statistical analyses revealed highly significant improvement (p<0.001) in anxiety, depression, insomnia, and pain. The effect size Cohen’s d values from a total of 237 treatments were greater than two standard deviations for all outcome measures indicating a high level of practical change from baseline to posttest supporting the capability of Alpha-Stim CES technology in reducing self-perceived symptoms and the ability to monitor progress on the Alpha-Stim app.

Conclusion

This treatment effect with Alpha-Stim CES on anxiety, insomnia, depression, and pain was consistent with prior surveys and confirmed the precision of the new app in determining progress from a single treatment and a series of treatments. The study design included a single subject convenience sample design using one pretest posttest trial with teachers choosing to participate or not (i.e., self-selecting into participation). Although anxiety was the most selected condition treated and insomnia showed the greatest improvement in this study that was followed closely by depression. All results were highly significant supporting the capability of Alpha-Stim CES technology in reducing self-perceived symptoms and the ability to monitor progress on the Alpha-Stim app.

Side-Effects

None reported

Limitations

There was no control group and the study was not a randomized controlled trial.