Does Cranial Electrotherapy Stimulation Help Treat Depression?

What you need to know

• Cranial electrotherapy stimulation (CES) with the Alpha-Stim AID device was tested as a treatment for depression in a large clinical trial
• The device was found to be safe and well-tolerated by patients
• However, the active device was no more effective than a placebo (sham) device in reducing depression symptoms
• Both groups showed some improvement in depression, possibly due to other factors like daily relaxation time

Background on depression and treatment options

Depression is a common and serious mental health condition that affects millions of people worldwide. It can cause persistent feelings of sadness, loss of interest in activities, and difficulty with daily functioning. While there are effective treatments available, including antidepressant medications and psychotherapy, many people do not fully respond to these options or experience unwanted side effects.

This has led researchers to investigate alternative treatment approaches, including devices that stimulate the brain. One such device is called cranial electrotherapy stimulation (CES), which delivers a very mild electrical current to the brain through electrodes placed on the ears.

The Alpha-Stim AID is a CES device that has been approved for treating anxiety, insomnia, and depression in some countries. Previous small studies suggested it might help reduce symptoms of anxiety and depression. However, there was a lack of large, well-designed studies testing whether it actually works for depression specifically.

About the study

Researchers in England conducted a clinical trial to determine if the Alpha-Stim AID device is effective for treating depression. This was the largest and most rigorous study of its kind to date.

The study recruited 236 adults with depression from primary care practices. To be eligible, participants had to:

• Be diagnosed with major depression
• Have moderate depression symptoms
• Have already tried or been offered antidepressant medication

The researchers randomly assigned participants to use either:

1. An active Alpha-Stim AID device
2. A placebo (sham) device that looked and sounded the same but did not deliver any electrical stimulation

Participants were instructed to use the device for 1 hour per day for 8 weeks. Neither the participants nor the researchers evaluating outcomes knew which type of device each person received.

The main outcome the researchers measured was change in depression symptoms after 16 weeks, using a standardized rating scale called the Hamilton Depression Rating Scale. They also looked at other measures of depression, anxiety, functioning, and quality of life.

Key findings

Safety and tolerability

The Alpha-Stim AID device was found to be safe and well-tolerated overall:

• Only 17 out of 236 participants (7%) reported any side effects
• Side effects were generally mild, with headache being most common
• There was only one serious adverse event, which occurred in the placebo group and was deemed unrelated to the device
• About 73% of participants were able to complete at least 28 hours of device use over the 8 weeks

Effectiveness for depression

The main finding was that the active Alpha-Stim AID device was no more effective than the placebo device for treating depression:

• Both groups showed some improvement in depression symptoms over time
• The amount of improvement was very similar between the active and placebo groups
• At 16 weeks, there was no significant difference between groups on the main depression outcome measure
• There were also no meaningful differences between groups on other measures of depression, anxiety, functioning, or quality of life

Other observations

• Participants in both groups showed clinically meaningful improvements in depression symptoms by 4 weeks, which were maintained at 8 and 16 weeks
• The placebo group actually showed slightly greater improvements than the active group on some secondary measures, though the differences were small
• About 30-40% of participants in both groups met criteria for treatment response or remission of depression by 16 weeks

Interpreting the results

The researchers concluded that while the Alpha-Stim AID device appears safe, it does not seem to provide any specific benefit for treating depression beyond placebo effects.

There are a few potential explanations for why both groups improved:

1. Placebo effect: Simply believing one is receiving treatment and having hope for improvement can lead to real changes in symptoms for some people.

2. Natural improvement over time: Depression symptoms can fluctuate and sometimes improve on their own, especially in people who have already tried other treatments.

3. Benefit of daily relaxation time: Setting aside an hour each day for a relaxing activity may have had some positive effects, regardless of whether the device was active.

4. Attention and support: Participating in a research study involves extra attention and follow-up, which could have therapeutic effects.

It’s important to note that this study focused specifically on people with major depression. The results don’t rule out potential benefits of CES for other conditions like anxiety disorders.

Implications and future directions

This study provides strong evidence that the Alpha-Stim AID device, when used as directed in this trial, is not an effective treatment for depression. The results highlight the importance of conducting rigorous, placebo-controlled studies to evaluate medical devices and other alternative treatments.

For patients and healthcare providers, the findings suggest that CES with the Alpha-Stim AID should not be recommended as a treatment for depression at this time. However, the overall safety of the device means it likely wouldn’t be harmful for those who choose to try it.

Future research could explore:

• Whether different “doses” or longer treatment periods with CES might be more effective
• If certain subgroups of people with depression might benefit more from CES
• The effectiveness of CES for other mental health conditions like anxiety disorders

More broadly, this study underscores the ongoing need to develop and rigorously test new treatment options for depression. While existing treatments help many people, there is still a significant unmet need for effective, well-tolerated alternatives.

Conclusions

• The Alpha-Stim AID device was safe and well-tolerated when used to treat depression
• However, it was no more effective than a placebo device in reducing depression symptoms
• Both groups showed some improvement, likely due to factors like placebo effects or benefits of daily relaxation time
• The results do not support recommending CES with Alpha-Stim AID as a treatment for depression
• More research is needed to develop new effective treatments for people with depression who don’t respond to existing options