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Neuromodulation Therapy

rTMS for Post-Concussion Syndrome

N/A

Waitlist Available

Led By Chantel T Debert, MD MSc FRCPC CSCN

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Concussion in the past 5 years attributed to current symptoms.

Age 18-65 yrs.

Must not have

Other medical conditions such as structural brain disease, previous seizure, psychiatric disorders excluding depression, PTSD and anxiety (schizophrenia, bipolar disorder), liver or kidney disease, malignancy, uncontrolled hypertension or diabetes, and pregnancy.

Prior history of TMS therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-months post-intervention

Summary

This trial is studying whether a treatment called repetitive transcranial magnetic stimulation (rTMS) can help people with chronic post-concussion symptoms.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While not explicitly stated in the provided information, common side effects of rTMS may include headache, scalp discomfort at the site of stimulation, tingling or spasms of facial muscles, lightheadedness, and rare risk of seizure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 65 years old.

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I have been diagnosed with long-lasting symptoms after a concussion.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have previously undergone TMS therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rivermead Post-Concussion Symptom Questionnaire (RPQ)

Secondary study objectives

Brief Trauma Questionnaire

British Columbia Post-concussion Symptom Inventory

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

+12 more

Other study objectives

Functional near infrared spectroscopy

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

rTMS

2016

Completed Phase 3

~840

0 / 5Eligibility criteria met