rTMS for Post-Concussion Syndrome

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byChantel T Debert, MD MSc FRCPC CSCN

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Calgary

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Every year, approximately 2 million people in the United States and 280,000 in Canada experience a mild traumatic brain injury/concussion. In patients with concussion, symptoms experienced following injury usually get better within 3 months. However, approximately 5-25% of people will experience symptoms beyond the 3 month period, characterized by persistent headaches, fatigue, insomnia, anxiety, depression, and thinking or concentration problems, which contribute to significant functional impairment. Chronic headache is the most common symptom following concussions. They can last beyond 5 years following injury, significantly impacting daily activities. To date, post-concussion symptoms have no known "cure". One potential approach to treating post-concussion symptoms may involve using drug-free interventions, such as neuromodulation therapy. This has the goal of restoring normal brain activity. Repetitive transcranial magnetic stimulation (rTMS) is one method currently being explored as a treatment option. TMS is a procedure where brain electrical activity is influenced by a magnetic field. Numerous studies using rTMS to treat other disorders, such as dementia, stroke, cerebral palsy, addictions, depression and anxiety, have shown much promise. The primary objective of this study is to determine whether rTMS treatment can significantly improve persistent post-concussion symptoms. A secondary objective is to explore the relationship between potential changes in brain function and clinical markers associated with rTMS treatment and how functional near-infrared spectroscopy (fNIRS), a neuroimaging technology, may be used to assess rTMS-treatment response.

Eligibility Criteria

This trial is for adults aged 18-65 with persistent post-concussion symptoms like headaches and cognitive issues, diagnosed per ICD-10 criteria. Participants must have had a concussion within the last 5 years and can't change their current medications during the study. Those with TMS contraindications or certain medical conditions are excluded.

Inclusion Criteria

My current medications can stay the same during the study.

I have had a concussion within the last 5 years causing my current symptoms.

My current medications can stay the same during the study.

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Exclusion Criteria

I do not have severe brain, liver, kidney diseases, uncontrolled high blood pressure or diabetes, and I am not pregnant.

You cannot participate if you have a pacemaker or metal implant that may be affected by TMS.

I have previously undergone TMS therapy.

Treatment Details

Interventions

rTMS (Neuromodulation Therapy)

Trial OverviewThe trial tests if repetitive transcranial magnetic stimulation (rTMS), a drug-free neuromodulation therapy, can improve chronic symptoms after a concussion. It also examines how brain function changes relate to clinical improvements using functional near-infrared spectroscopy (fNIRS) as a response marker.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment groupExperimental Treatment1 Intervention

Patients will engage in a four-week treatment protocol (20 treatments). This was chosen as it is the midpoint between typical depression and migraine protocol durations. A standardized atlas brain with Montreal neurologic institute (MNI) coordinates will be used for navigation. The DLPFC will be located through MNI coordinates (-50, 30, 36). The intensity of the rTMS will be 100-120% of resting motor threshold amplitude, with a frequency of 10 Hz, 10 trains of 60 pulses/train (total of 600 pulses) and an inter-train interval of 45s.

Group II: Sham groupPlacebo Group1 Intervention

In the sham condition, a sham coil will be applied to the scalp after the resting motor threshold is determined. Patients will be able to hear the sound and feel the vibration of sham coil, but will not experience any effective stimulation. Previous sham studies have demonstrated efficacy of the blinding method.

rTMS is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as rTMS for: