Upstate Medical University is seeking volunteers for a research study using 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.

Led by Principal Investigator Yi-Ling Kuo, PT, PhD, assistant professor in the Department of Physical Therapy Education in the College of Health Professions,  the study aims to further existing literature on repetitive transcranial magnetic stimulation (rTMS), which stimulates the brain using a magnetic field. To date, it has been shown to reduce concussion symptoms such as headaches for one month after treatment.

“Our project is extending the follow-up window to see if there’s any longer-term effect,” Kuo said. “We are following up for six months. Additionally, we will search for biomarkers (through bloodwork) to identify good candidates for rTMS.”

Kuo has been doing brain stimulation research for more than 10 years and has used brain stimulation to study the human motor system in other populations such as patients who have experienced a stroke or have movement disorders like dystonia.

Unlike other forms of electrical stimulation, rTMS is painless and induces changes in brain activity with the most robust effect among non-invasive brain stimulation techniques. It is administered via a coil held on the participant’s head for up to 30 minutes each session. Participants sit in a reclined chair while the treatment is administered and muscle activity is monitored through sensors attached to their hands to infer brain activation. While the participants only feel mild tapping on their heads during rTMS, muscles and nerves near the stimulating coil are activated, which can rarely result in twitch-like contraction of muscles in the face, neck, and arms if done at high intensity (which it will not be during this study.)

The goal with the rTMS is to modulate the motor cortex and further change brain networks.

“We are targeting the motor cortex, which is the part of the brain that controls the output of movement,” Kuo said. “That part of the brain is the end point to generate movement and also part of the pain network. The tricky thing with mild traumatic brain injury is that typically there is no pathology noticeable in the brain, but there are some subtle changes in the network that make headaches linger. Fortunately, this can be tackled by rTMS.”

In this clinical trial, participants will be randomly assigned to receive either active rTMS or sham rTMS (no active stimulation). They will receive rTMS in three sessions per week for four weeks for a total of two hours and are followed for six months. Those who receive sham rTMS will have the choice to receive active rTMS once the study protocol is completed.

The first and last sessions will be two hours long, including treatment and assessments. Other treatment-only sessions will be 30 minutes. Participants will undergo some assessments to determine the treatment efficacy, including questionnaires, wearable sensors, blood draws, and brain stimulation.

Side effects of the treatment happen to less than 5 percent of the participants and can include neck pain or discomfort in the scalp. The most serious, but rare, side effect is the risk for seizure. Participants will go through safety screening beforehand to minimize the chance of side effects.

To be eligible, participants must have persistent or chronic headaches resulting from a concussion that have lasted more than three months. Participants are asked to keep a daily headache diary, wear a sensor that monitors physical activity and sleep, do blood work and answer questionaries throughout the study. rTMS will be administered at the Institute for Human Performance (IHP). Compensation will be provided. To participate or inquire for more information, email Kuo at [email protected]. 

 

Caption: Researcher Yi-Ling Kuo, PT, PhD, assistant professor in the Department of Physical Therapy Education in the College of Health Professions, demonstrates the use of transcranial magnetic stimulation (rTMS) as part of a clinical trial for chronic headaches and other post-concussion symptoms in people with mild traumatic brain injury.