Experimenting with magnets to treat headaches after mild traumatic brain injury

[00:00:00] Host Amber Smith: Upstate Medical University in

[00:00:03] Yi-Ling Kuo, PhD: Syracuse, New York invites you to be "The Informed Patient" with the podcast that features experts from Central New York's only academic medical center. I'm your host, Amber Smith. A physical therapist and researcher is seeking volunteers for a study that uses a non-invasive brain stimulation technique as a novel treatment for chronic headaches and other post-concussion symptoms in people with mild traumatic brain injury. Here to talk about this study and how you can get involved is physical therapist Yi-Ling Kuo, who is an assistant professor in the department of physical therapy education in Upstate's College of Health Professions. Welcome to "The Informed Patient,"

Thank you for having me.

[00:00:45] Host Amber Smith: What is this non-invasive brain stimulation technique?

[00:00:50] Yi-Ling Kuo, PhD: The technique that we're going to be using is called transcranial magnetic stimulation, or TMS. It is a type of non-invasive stimulation technique that stimulates your brain, but without opening up your skull. And we reach some findings with some signals so that we get to know what's going on inside your brain indirectly.

There are different forms of TMS. Some forms are used for assessment, which means that we monitor your brain status. And other forms are called repetitive transcranial magnetic stimulation, or RTMS, which is the form that's going to be used in this study. And it has the capability to modulate the brain status so that it's used for treatment.

[00:01:40] Host Amber Smith: So there's no incision. The magnets do their work through the skin, through the bone, through the muscle?

[00:01:47] Yi-Ling Kuo, PhD: Exactly. Yep.

[00:01:48] Host Amber Smith: Interesting.

Can you tell me how magnets affect the brain? .

[00:01:52] Yi-Ling Kuo, PhD: So the stimulation coil will generate magnetic field to simulate the brain. The magnetic field will make current generated in the brain, and that electric current will stimulate the neurons in the brain. And this mechanism is called electromagnetic induction. And that was discovered by Michael Faraday in the 19th century. So the stimulated neuron, by the current, will then activate and fire and generate potential to move your body. So we capture the response in the movement to tell what's going on inside the brain in an indirect way.

[00:02:40] Host Amber Smith: Is this already being used to treat regular headaches?

[00:02:44] Yi-Ling Kuo, PhD: So currently the use of RTMS in headaches is in an investigational stage, which means that's used in only research. It's not been FDA approved for headaches for clinical use yet. But RTMS has been FDA approved for other mental illnesses, including depression, which is the most well known one.

So we're using RTMS in headaches in this study as an off-label application.

[00:03:13] Host Amber Smith: I understand you've been involved in brain stimulation research for more than a decade.

Have you always focused on magnets?

[00:03:21] Yi-Ling Kuo, PhD: Myself, yes. My research is primarily in TMS, but there are actually many other forms of non-invasive brain stimulation, including, for example, transcranial direct current stimulation that uses electrical current to stimulate the brain, or ultrasound stimulation, or near infrared lights for stimulation, et cetera.

But for myself, yes, TMS is my primary focus.

[00:03:47] Host Amber Smith: Please walk us through how this transcranial magnetic stimulation works. Is this done in a medical office, or a hospital?

[00:03:56] Yi-Ling Kuo, PhD: For clinical use, it is used in a clinic, so it can be a clinic or in a hospital. But for research use, so like us, we use that in a research laboratory.

[00:04:08] Host Amber Smith: And are patients sitting up or laying down? How is this applied to them?

[00:04:14] Yi-Ling Kuo, PhD: So they will be reclined, sitting in your chair. That chair will be similar to a dental chair, so that we'll recline the chair, and the patient can be semi lying on that chair.

[00:04:26] Host Amber Smith: And they don't need to shave their hair or anything? This works right through their hair, right?

[00:04:32] Yi-Ling Kuo, PhD: Exactly, yes. So the magnetic field penetrates the air, the hair, and the skull to reach the surface of the brain. We don't require any preparation of the hair to be shaved or in any other way. The patient can just receive TMS as they are, after they walk into the clinic or the laboratory.

[00:04:52] Host Amber Smith: So is this like a hat that goes over their head?

[00:04:56] Yi-Ling Kuo, PhD: Well, we use a coil that's connected to the stimulator. So the coil, it can be in different shapes, but the most commonly used and the one being used in our study is in a figure eight shape. So that coil will be placed upon the head, and to generate magnetic field to stimulate the surface of the brain.

[00:05:20] Host Amber Smith: What do the patients feel during the treatment session? Or, I guess I should call them subjects because it's a research project. What do they feel during the treatment session?

[00:05:31] Yi-Ling Kuo, PhD: So there will be a tapping kind of feeling on their scalp. It is painless, and the strength of the tapping will depend on the stimulation intensity. So if I turn up the intensity a little bit more, they may feel the tapping to be stronger, but it is always painless. Some people may feel the stimulation being spread out to their facial muscles, so they may experience some twitches in their facial muscles. And also, depending on where we target in the brain area, for example, if we target the motor area, let's say the hand, when we simulate the hand area in the brain, the subject may feel muscle twitches in their hand as well.

[00:06:16] Host Amber Smith: Interesting. So I know you're monitoring during these sessions. What is the goal of these sessions?

[00:06:23] Yi-Ling Kuo, PhD: We monitor the participants using some signals. For example, electromyography or EMG is the one that we use to monitor muscle activity because in this study we target the motor area in the brain.

So, those signals will be analyzed to help us interpret what's going on inside the brain. But other than the muscle activities, we will also monitor the participants in their facial expression or relying on their reports to us to see how they respond to the treatment during the experiment.

[00:07:00] Host Amber Smith: This is Upstate's "The Informed Patient" podcast. I'm your host, Amber Smith. I'm talking with physical therapist, Yi-Ling Kuo from Upstate's College of Health Professions.

Now, Dr. Kuo, for the study, what people are you looking for?

[00:07:15] Yi-Ling Kuo, PhD: We are looking for people with mild traumatic brain injury, with chronic, unresolved post-concussion headaches. So if people have chronic headaches for more than three months, and that's not resolved after standard care, then those will be the target for our study.

[00:07:33] Host Amber Smith: What is traumatic brain injury, and how would a person know if theirs was mild or more severe?

[00:07:41] Yi-Ling Kuo, PhD: A mild traumatic brain injury typically means that after the person hit in the head -- for example due to motor vehicle accidents, sports injury, or full accident -- those symptoms will not be life threatening. And typically there's no pathology detectable with new imaging like CT (coputerized tomography) or MRI (magnetic resonance imaging.) So that's why they're considered mild.

And typically symptoms go away within a month with proper management. But some people, their symptoms might last outside of the normal recovery window. And for those who have headaches, for example, that will be the target in this study.

[00:08:22] Host Amber Smith: How long ago could the people have had a traumatic brain injury in order to be included? Do these have to be relatively current?

[00:08:33] Yi-Ling Kuo, PhD: Well, we do not limit the onset time of the headaches or the concussion to be enrolled in this study. It's that we said the inclusion criteria should be the timing or the length of the headache that's going on out there.

So, chronic headaches for more than three months, and if the patient went through standard care and that's not resolved, then those will be the target for our study.

[00:09:01] Host Amber Smith: Are there any other symptoms besides headache that you're also including?

[00:09:07] Yi-Ling Kuo, PhD: Well, so, we will also monitor the changes in other post-concussion symptoms such as dizziness, difficulty concentrating, anxiety, memorizing issues, or trouble sleeping. Those are secondary symptoms being monitored. But for the main thing being studied in the study, will be headaches, the chronic ones.

[00:09:32] Host Amber Smith: And are you looking for men, women, what ages? races?

[00:09:38] Yi-Ling Kuo, PhD: We will be recruiting both men and women. There's no limitation in race, and we will be targeting adults. So they need to be older than 18 years old.

[00:09:51] Host Amber Smith: Is there anything that would exclude someone from participating, medically?

[00:09:57] Yi-Ling Kuo, PhD: If someone's headaches happened prior to the concussion or the diagnosis of mild traumatic brain injury, that means their headaches, came from something else. Then those people won't be studied in our experiment.

And for people who have metal implants inside their body that has electromagnetic steel -- for example, a pacemaker that's helping their heart to rhythm -- those patients will be excluded as well. And also someone who has a history of seizure or epilepsy, those people will be excluded as well. And we do use safety screening questionnaires just to make sure that the patients are eligible to receive TMS.

[00:10:40] Host Amber Smith: Will all the volunteers receive the TMS therapy?

[00:10:45] Yi-Ling Kuo, PhD: So in the experimental stage, they will be randomly assigned to either receive active or sham stimulation. So sham means that there's no active or real stimulating applied to their brain, and this is for scientific methodology purposes to minimize the effect of placebo.

But after they complete the experimental stage, they will be unblinded to know which group they were assigned to. And for those who are in the sham group can opt to receive active RTMS after we're done with the entire procedure. And we offer that at no cost.

[00:11:26] Host Amber Smith: I see. Now, if the volunteers are signing up for this, what's expected of them? How long are the sessions that they go to, and how long does this last?

[00:11:36] Yi-Ling Kuo, PhD: We would ask the volunteers to keep a total of 12 sessions of appointments to the laboratory.

And also throughout the treatment course, within four weeks, we will ask them to complete a daily diary to track their headache, intensity, frequency, things like that, and also sleep and their physical activity levels.

And we would also ask the participants to not start a new treatment for their headaches while they are in this study.

[00:12:10] Host Amber Smith: So 12 sessions, would that be spread out over a year, or less, or more?

[00:12:15] Yi-Ling Kuo, PhD: Twelve sessions will be spread out in four weeks, typically. So we do three times a week for a total of four weeks to complete those 12 sessions of RTMS.

[00:12:27] Host Amber Smith: So what's the best way for someone who's interested in participating to learn more?

[00:12:32] Yi-Ling Kuo, PhD: If they are interested in participating, they can contact us through my email address, [email protected].

[00:12:43] Host Amber Smith: What do you plan to do with your results?

[00:12:45] Yi-Ling Kuo, PhD: We will eventually publish the findings in scientific conferences and journals. So that's the first thing. Secondly, we will use the data to obtain future funding so that we can refine RTMS protocols and to better individualize, to maximize patient responsiveness.

So we do expect the preliminary results to be out in a few months, probably in a conference. and the completion of the entire study will be probably one to two years from now. And also we are happy to send the results to the participants if they're willing to know what's happening.

[00:13:27] Host Amber Smith: Very good to know. Dr. KUO, thank you so much for making time for this interview.

[00:13:32] Yi-Ling Kuo, PhD: Thank you so much. And I look forward to any participation that we can welcome.

[00:13:38] Host Amber Smith: My guest has been physical therapist Yi-Ling Kuo, an assistant professor in the department of physical therapy education in Upstate's College of Health Professions. "The Informed Patient" is a podcast covering health, science and medicine, brought to you by Upstate Medical University in Syracuse, New York, and produced by Jim Howe. Find our archive of previous episodes at upstate.edu/informed. If you enjoyed this episode, please tell a friend to listen too. And you can rate and review "The Informed Patient" podcast on Spotify, Apple Podcasts, YouTube, or wherever you tune in. This is your host, Amber Smith, thanking you for listening.