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Benefits of Alpha-Stim
Lila Massoumi, MD
Chairperson, Caucus on Complementary, Alternative, and Integrative Medicine, American Psychiatric Association
Dr. Massoumi has disclosed that she has no relevant financial or other interests in any commercial companies pertaining to this educational activity.
TCPR: Dr. Massoumi, you are one of the most nationally prominent psychiatrists teaching about complementary and alternative medicine (CAM) treatments. We’re happy that you could help us with this special issue of TCPR. When did you get interested in this topic and why?
Dr. Massoumi: I come from a long line of doctors in my family, and I always felt that medicine should be about attaining optimal health rather than simply treating disease. During med school, I learned about the American Holistic Medical Association (now called the Academy of Integrative Health and Medicine, https://www.aihm.org/). And once I discovered them, I felt that I had found like-minded professionals. I pretty much went through medical school as a kind of “closeted” integrative medicine enthusiast. I didn’t really emerge until late in my psychiatry residency when I created my own elective in alternative or integrative medicine.
TCPR: Tell us a little about your practice.
Dr. Massoumi: Sure. I started my practice in 2011, and it is called Michigan Integrative Holistic Psychiatry. I work with two physician assistants, two therapists, and a therapy dog. [Editor’s note: See CCPR, November 2014 for a research update on the benefits of pet therapy.] We accept insurance, and in my work with patients I combine both conventional psychopharmacology and natural medicines.
TCPR: CAM in psychiatry is such a large topic, and in the lead article for this issue you’ve written a nice review of the more common natural medicines and supplements. I thought we could focus this interview on another type of alternative treatment that you’ve had experience with, this one a device rather than a medication or supplement: cranial electrotherapy stimulation (CES). Am I using the correct terminology?
Dr. Massoumi: Yes, and it does go by different terminology. Transcranial alternating or pulsed current stimulator is another term. These devices are basically very low-current stimulators that people can wear at home daily for a short period of time.
TCPR: How did you get interested in CES?
Dr. Massoumi: I learned about CES from a conference at the American Holistic Medical Association. I was initially pretty skeptical, but when I put it on, it caused an almost immediate shift in my mental state—I felt exactly like I had had a glass of wine or had taken a Xanax. It was a sensation of relaxation.
TCPR: So you just literally tried it on yourself?
Dr. Massoumi: Yes. If I feel assured that a treatment is safe, I always use myself as the guinea pig before I recommend it to my patients. Once I tried it, I purchased a few different brands of devices and tried those out as well. Some are FDA-cleared and some aren’t.
TCPR: What exactly does FDA clearance mean? Is it similar to FDA approval for medications?
Dr. Massoumi: Unfortunately, it appears that the FDA’s procedures for evaluating the safety and efficacy of medical devices is far less efficient and transparent than it is for medications. Without getting into too much detail, the bottom line is that you as the clinician need to perform your own review of the literature. The majority of potentially therapeutic devices have not been reviewed by the FDA, while other devices with FDA clearance were grandfathered in. Thus, the presence or absence of FDA clearance or approval is not a verdict on safety or efficacy.
TCPR: Is there good evidence for the efficacy of the CES devices?
Dr. Massoumi: That depends on what you consider “good evidence.” If you are thinking about the sorts of large randomized controlled trials that we see for FDA-approved antidepressants, then no, these devices have nowhere near that level of evidence. In fact, in a recent Cochrane review of CES for depression, the reviewers couldn’t find a single article that met their criteria for a high-quality, large clinical trial (Kavirajan HC et al, Cochrane Database Syst Rev;2014(7):CD010521. doi:10.1002/14651858.CD010521.pub2). I read TCPR’s recent review (August 2015) of the Fisher Wallace device for depression, which concluded that there isn’t enough evidence to conclude that it’s effective, and I agree. I’ve tried CES for depression and have not found it helpful in my patients. On the other hand, there’s somewhat better evidence that these devices work for a range of anxiety symptoms (Barclay TH and Barclay RD, J Affect Disorder 2014;(164):171–177).
TCPR: Before we get into specifics, do you have any financial relationships with any of the companies that make these devices?
Dr. Massoumi: Absolutely not, nor do I sell any of the devices in my clinic—or any supplements, for that matter—because that’s a conflict of interest.
TCPR: So which CES products are you most likely to recommend to your patients and why?
Dr. Massoumi: I recommend the Alpha-Stim device primarily. Many of my patients have PTSD, and I have found no medication treatment better for PTSD than Alpha-Stim. I also have a large population of patients who, due to their extensive history of childhood traumas, have dissociative disorders. Sometimes, the “spaciness” of being in a dissociated state can present like the inattention of ADD. I have found Alpha-Stim extremely helpful for both the hypervigilance of PTSD and the cognitive spaciness of the other dissociative disorders.
TCPR: What else is it helpful for?
Dr. Massoumi: I’ve had good success in using it for generalized anxiety disorder, insomnia, benzodiazepine addiction, as well as various syndromes, especially treatment resistant migraines. If I have any patients with anxiety who are averse to taking medication, I immediately have them try CES. I find it particularly helpful for insomnia in women who are in perimenopause or menopause.
TCPR: Do you have any examples that you can share with us?
Dr. Massoumi: Sure. I have a long-term patient with panic disorder with agoraphobia that I inherited as a psychiatry resident, whom I saw weekly for counseling and medication management. Her symptoms were so severe that she felt unable to travel to visit her grandchildren, and she would cry in session with me about her fear of traveling. No amount of benzodiazepine, SSRI, or atypical antipsychotic (alone or in combination) was successful at getting her comfortable with traveling. After two weeks of using the Alpha-Stim daily, she returned to her session and notified me nonchalantly that she would be missing her following week’s appointment, as she had purchased train tickets to visit her grandchildren.
TCPR: Interesting. What do these devices look like, and how do patients actually use them?
Dr. Massoumi: The Alpha-Stim is a handheld unit that looks like a smartphone. There’s a wire coming out of it, and on the other side of the wire are ear clips. So you clip it to your earlobes where the earrings go. If you have long hair, to a bystander it might just look like you’re simply listening to music.
TCPR: Is it easy for patients to use?
Dr. Massoumi: Yes, and what I like about the Alpha-Stim device in particular is that the dosing is extremely clear: The device is labeled on an intensity scale from 0 to 5. You turn it on and use a button to dial up to the point that you feel dizzy or nauseous. That’s your ceiling—that’s where you should not be. So you then you dial it down one-half to 1 point until you are no longer dizzy or nauseous, and that is your treatment intensity for that particular session. That’s where you’re going to stay for the duration of the treatment.
TCPR: And how long does the session last?
Dr. Massoumi: If you’re at an intensity level of 3 and above, your treatment only needs to be for 20 minutes. If you’re below 3, so let’s say 2.5 and below, your treatment needs to be for 1 full hour. On some days you’ll be able to handle a lot more intensity versus other days or even alternating within a day.
TCPR: Are these parameters that the company recommends, or are these things that you’ve found helpful?
Dr. Massoumi: That’s what the company recommends and what I would endorse.
TCPR: So when patients get the device, at the point where they are not nauseous or dizzy, what’s their physical reaction?
Dr. Massoumi: They immediately feel calm. That’s one of the things I like about the Alpha-Stim; as soon as my patients put it on, the vast majority feel the effects. So this enhances compliance because there’s that instant reward. Occasionally you’ll have patients who say that they didn’t notice anything, but then they’ll tell me afterwards that they went to Home Depot or another place where they normally couldn’t because it’s so overstimulating, yet they were able to shop there feeling calm.
TCPR: How long does the effect last?
Dr. Massoumi: One treatment lasts approximately 24 hours. So we recommend that patients use it every day; it’s cumulative with maximum effect at 4–6 weeks.
TCPR: But patients must ultimately purchase the device, which can be cost-prohibitive, right?
Dr. Massoumi: Correct. It is an $800 piece of equipment. I have multiple units at my office, and patients are allowed to come at any time and use it for free, but of course they would need to be within a certain driving distance for it to be feasible for them. Realistically, if I have a patient lacking means and they are amenable to taking a medication for their condition, then I’m not going to ask them to buy an $800 unit.
TCPR: I can see that. Are there any side effects?
Dr. Massoumi: The most common side effect is tension headache, which occurs in about 1 in 1,000 patients. I like patients to try one in my office before purchasing one to rule out that side effect. And it’s important that you stress to patients not to dose it too high—if they keep it at the level that causes them to feel dizzy or nauseous, then unfortunately those feelings will also last for the 24 hours afterwards.
TCPR: Do you combine medications with Alpha-Stim?
Dr. Massoumi: Absolutely.
TCPR: How about contraindications? Are there any patients who should not use Alpha-Stim?
Dr. Massoumi: A contraindication is if you have a pacemaker. And they have not done human studies in pregnancy. And then occasionally there will be some patients who are just too sensitive to use Alpha-Stim. They can’t get above 0.5, and if you can’t get above that threshold, then you’re talking about a 3-hour duration of treatment, which is impractical.
TCPR: So you said you recommend 4–6 weeks of daily treatments—assuming they respond, what happens after that?
Dr. Massoumi: Then it’s maintenance 2 to 3 times a week. I’d say the biggest problem I have with Alpha-Stim is that once they feel better and they go into the tapering phase, they eventually stop using it altogether. These are the patients that come back to me several months later complaining of recurrence of anxiety. If this was because they stopped using the device, my job is just to tell them to start back up.
TCPR: Aside from going to the American Psychiatric Association meeting or one of the holistic meetings, how could the average psychiatrist go out there and just test it out?
Dr. Massoumi: The Alpha-Stim company is extremely helpful. You can go to their website (http://alpha-stim.com) to inquire about a local practitioner, and then just call that practitioner to ask if you could come by and use it for a couple of minutes to try it out.
TCPR: Good to know. Thanks very much for your time, Dr. Massoumi.
Dr. Massoumi: I come from a long line of doctors in my family, and I always felt that medicine should be about attaining optimal health rather than simply treating disease. During med school, I learned about the American Holistic Medical Association (now called the Academy of Integrative Health and Medicine, https://www.aihm.org/). And once I discovered them, I felt that I had found like-minded professionals. I pretty much went through medical school as a kind of “closeted” integrative medicine enthusiast. I didn’t really emerge until late in my psychiatry residency when I created my own elective in alternative or integrative medicine.
TCPR: Tell us a little about your practice.
Dr. Massoumi: Sure. I started my practice in 2011, and it is called Michigan Integrative Holistic Psychiatry. I work with two physician assistants, two therapists, and a therapy dog. [Editor’s note: See CCPR, November 2014 for a research update on the benefits of pet therapy.] We accept insurance, and in my work with patients I combine both conventional psychopharmacology and natural medicines.
TCPR: CAM in psychiatry is such a large topic, and in the lead article for this issue you’ve written a nice review of the more common natural medicines and supplements. I thought we could focus this interview on another type of alternative treatment that you’ve had experience with, this one a device rather than a medication or supplement: cranial electrotherapy stimulation (CES). Am I using the correct terminology?
Dr. Massoumi: Yes, and it does go by different terminology. Transcranial alternating or pulsed current stimulator is another term. These devices are basically very low-current stimulators that people can wear at home daily for a short period of time.
TCPR: How did you get interested in CES?
Dr. Massoumi: I learned about CES from a conference at the American Holistic Medical Association. I was initially pretty skeptical, but when I put it on, it caused an almost immediate shift in my mental state—I felt exactly like I had had a glass of wine or had taken a Xanax. It was a sensation of relaxation.
TCPR: So you just literally tried it on yourself?
Dr. Massoumi: Yes. If I feel assured that a treatment is safe, I always use myself as the guinea pig before I recommend it to my patients. Once I tried it, I purchased a few different brands of devices and tried those out as well. Some are FDA-cleared and some aren’t.
TCPR: What exactly does FDA clearance mean? Is it similar to FDA approval for medications?
Dr. Massoumi: Unfortunately, it appears that the FDA’s procedures for evaluating the safety and efficacy of medical devices is far less efficient and transparent than it is for medications. Without getting into too much detail, the bottom line is that you as the clinician need to perform your own review of the literature. The majority of potentially therapeutic devices have not been reviewed by the FDA, while other devices with FDA clearance were grandfathered in. Thus, the presence or absence of FDA clearance or approval is not a verdict on safety or efficacy.
TCPR: Is there good evidence for the efficacy of the CES devices?
Dr. Massoumi: That depends on what you consider “good evidence.” If you are thinking about the sorts of large randomized controlled trials that we see for FDA-approved antidepressants, then no, these devices have nowhere near that level of evidence. In fact, in a recent Cochrane review of CES for depression, the reviewers couldn’t find a single article that met their criteria for a high-quality, large clinical trial (Kavirajan HC et al, Cochrane Database Syst Rev;2014(7):CD010521. doi:10.1002/14651858.CD010521.pub2). I read TCPR’s recent review (August 2015) of the Fisher Wallace device for depression, which concluded that there isn’t enough evidence to conclude that it’s effective, and I agree. I’ve tried CES for depression and have not found it helpful in my patients. On the other hand, there’s somewhat better evidence that these devices work for a range of anxiety symptoms (Barclay TH and Barclay RD, J Affect Disorder 2014;(164):171–177).
TCPR: Before we get into specifics, do you have any financial relationships with any of the companies that make these devices?
Dr. Massoumi: Absolutely not, nor do I sell any of the devices in my clinic—or any supplements, for that matter—because that’s a conflict of interest.
TCPR: So which CES products are you most likely to recommend to your patients and why?
Dr. Massoumi: I recommend the Alpha-Stim device primarily. Many of my patients have PTSD, and I have found no medication treatment better for PTSD than Alpha-Stim. I also have a large population of patients who, due to their extensive history of childhood traumas, have dissociative disorders. Sometimes, the “spaciness” of being in a dissociated state can present like the inattention of ADD. I have found Alpha-Stim extremely helpful for both the hypervigilance of PTSD and the cognitive spaciness of the other dissociative disorders.
TCPR: What else is it helpful for?
Dr. Massoumi: I’ve had good success in using it for generalized anxiety disorder, insomnia, benzodiazepine addiction, as well as various syndromes, especially treatment resistant migraines. If I have any patients with anxiety who are averse to taking medication, I immediately have them try CES. I find it particularly helpful for insomnia in women who are in perimenopause or menopause.
TCPR: Do you have any examples that you can share with us?
Dr. Massoumi: Sure. I have a long-term patient with panic disorder with agoraphobia that I inherited as a psychiatry resident, whom I saw weekly for counseling and medication management. Her symptoms were so severe that she felt unable to travel to visit her grandchildren, and she would cry in session with me about her fear of traveling. No amount of benzodiazepine, SSRI, or atypical antipsychotic (alone or in combination) was successful at getting her comfortable with traveling. After two weeks of using the Alpha-Stim daily, she returned to her session and notified me nonchalantly that she would be missing her following week’s appointment, as she had purchased train tickets to visit her grandchildren.
TCPR: Interesting. What do these devices look like, and how do patients actually use them?
Dr. Massoumi: The Alpha-Stim is a handheld unit that looks like a smartphone. There’s a wire coming out of it, and on the other side of the wire are ear clips. So you clip it to your earlobes where the earrings go. If you have long hair, to a bystander it might just look like you’re simply listening to music.
TCPR: Is it easy for patients to use?
Dr. Massoumi: Yes, and what I like about the Alpha-Stim device in particular is that the dosing is extremely clear: The device is labeled on an intensity scale from 0 to 5. You turn it on and use a button to dial up to the point that you feel dizzy or nauseous. That’s your ceiling—that’s where you should not be. So you then you dial it down one-half to 1 point until you are no longer dizzy or nauseous, and that is your treatment intensity for that particular session. That’s where you’re going to stay for the duration of the treatment.
TCPR: And how long does the session last?
Dr. Massoumi: If you’re at an intensity level of 3 and above, your treatment only needs to be for 20 minutes. If you’re below 3, so let’s say 2.5 and below, your treatment needs to be for 1 full hour. On some days you’ll be able to handle a lot more intensity versus other days or even alternating within a day.
TCPR: Are these parameters that the company recommends, or are these things that you’ve found helpful?
Dr. Massoumi: That’s what the company recommends and what I would endorse.
TCPR: So when patients get the device, at the point where they are not nauseous or dizzy, what’s their physical reaction?
Dr. Massoumi: They immediately feel calm. That’s one of the things I like about the Alpha-Stim; as soon as my patients put it on, the vast majority feel the effects. So this enhances compliance because there’s that instant reward. Occasionally you’ll have patients who say that they didn’t notice anything, but then they’ll tell me afterwards that they went to Home Depot or another place where they normally couldn’t because it’s so overstimulating, yet they were able to shop there feeling calm.
TCPR: How long does the effect last?
Dr. Massoumi: One treatment lasts approximately 24 hours. So we recommend that patients use it every day; it’s cumulative with maximum effect at 4–6 weeks.
TCPR: But patients must ultimately purchase the device, which can be cost-prohibitive, right?
Dr. Massoumi: Correct. It is an $800 piece of equipment. I have multiple units at my office, and patients are allowed to come at any time and use it for free, but of course they would need to be within a certain driving distance for it to be feasible for them. Realistically, if I have a patient lacking means and they are amenable to taking a medication for their condition, then I’m not going to ask them to buy an $800 unit.
TCPR: I can see that. Are there any side effects?
Dr. Massoumi: The most common side effect is tension headache, which occurs in about 1 in 1,000 patients. I like patients to try one in my office before purchasing one to rule out that side effect. And it’s important that you stress to patients not to dose it too high—if they keep it at the level that causes them to feel dizzy or nauseous, then unfortunately those feelings will also last for the 24 hours afterwards.
TCPR: Do you combine medications with Alpha-Stim?
Dr. Massoumi: Absolutely.
TCPR: How about contraindications? Are there any patients who should not use Alpha-Stim?
Dr. Massoumi: A contraindication is if you have a pacemaker. And they have not done human studies in pregnancy. And then occasionally there will be some patients who are just too sensitive to use Alpha-Stim. They can’t get above 0.5, and if you can’t get above that threshold, then you’re talking about a 3-hour duration of treatment, which is impractical.
TCPR: So you said you recommend 4–6 weeks of daily treatments—assuming they respond, what happens after that?
Dr. Massoumi: Then it’s maintenance 2 to 3 times a week. I’d say the biggest problem I have with Alpha-Stim is that once they feel better and they go into the tapering phase, they eventually stop using it altogether. These are the patients that come back to me several months later complaining of recurrence of anxiety. If this was because they stopped using the device, my job is just to tell them to start back up.
TCPR: Aside from going to the American Psychiatric Association meeting or one of the holistic meetings, how could the average psychiatrist go out there and just test it out?
Dr. Massoumi: The Alpha-Stim company is extremely helpful. You can go to their website (http://alpha-stim.com) to inquire about a local practitioner, and then just call that practitioner to ask if you could come by and use it for a couple of minutes to try it out.
TCPR: Good to know. Thanks very much for your time, Dr. Massoumi.
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