GyroStim for Post Concussion Syndrome

This study is looking at whether a treatment called Sensorimotor Multi-axis Automated Rotational Therapy (SMART) using a device called GyroStim can help adults with Post Concussion Syndrome (PCS). PCS means you have symptoms that last for a long time after a head injury. All participants will also receive standard physical therapy and speech therapy. Researchers want to see if adding GyroStim therapy helps people improve faster and more significantly with their headaches, dizziness, and other concussion symptoms. You might be able to join if you are an adult (18 or older) with a history of head injury, ongoing PCS symptoms for at least 4 weeks, and problems with balance or dizziness. The current status of this study is unclear.

Study design: This study aims to enroll 128 participants to compare the effects of GyroStim therapy combined with standard care versus standard care alone for Post Concussion Syndrome.
What's involved: Participants will have physical therapy and speech therapy once a week. Those in the intervention group will also have 10 GyroStim sessions, with symptom assessments taken at the first and last physical therapy visits.
Compensation: Not stated in the trial record.
Follow-up: Your symptoms will be measured at the first physical therapy visit and again at the last visit, which is between 3-6 weeks after starting the intervention.

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GyroStim for Post Concussion Syndrome

Recruiting

NAAges 18+InterventionalTreatment

Neuroscience Group

~128 participants

Updated 2026-06-10 on ClinicalTrials.gov

What's tested:Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim devicePhysical therapy and speech therapy/cognitive rehabilitation therapy

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Headache Impact Test (HIT-6)

Measured over First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.

+7 more outcomes measured

Conditions

Post Concussion Syndrome

Where it's being run

1 sites across 1 states

Wisconsin1

Study leadership

Benjamin Siebert, MD · STUDY_DIRECTOR · Neuroscience Group

Who to contact

Nichole J Siebert, MS

[email protected]

920-725-9373

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subjects may have received care for their concussion and related symptoms from other providers prior to seeking care at Neuroscience Group. Providing they meet the above criteria, they will not be excluded from participation, as long as they are not doing PT or ST/CRT concurrently or have previously done SMART elsewhere for the treatment of this head injury.

Exclusion

include those patients under 18 years of age, those not competent to consent, those with a concussion that occurred less than 4 weeks prior to initial visit, weighing greater than 400lbs, greater than 7ft tall, those unable to communicate verbally, pregnant, less than 12 weeks post-partum, active benign paroxysmal positional vertigo (BPPV), severe claustrophobia, uncontrolled hypertension, uncontrolled seizures, ankylosing spondylitis, concern for postural cardiac issues, active cervical radiculopathy or active cauda equina symptoms, Chiari malformation Type II-IV, detached retina, or severe limitations with cervical range of motion. Other exclusions include those with neurological disorders including multiple sclerosis and Parkinson's, severe depression or anxiety, those with hearing impairments, and significant vision dysfunction, and recent upper extremity injury.

As pregnancy is an exclusion, medical staff will have potential female subjects fill out a pregnancy questionnaire (see Appendix K) to determine if pregnancy is a possibility. If it is possible, the subject will be given a form (see Appendix L) and provided with a home pregnancy test and package instructions (or they may use their own), which will need to be filled out and returned at the beginning of their first therapy visit. The home pregnancy test will need to be done within 3 days of their first visit. They will also be advised to continue with proper contraception or abstinence, and they will also be informed that should they become pregnant, they will need to notify a member of our medical staff at Neuroscience Group as soon as possible.

Exclusions with special consideration and approval from provider may include post-surgical patients (must be greater than 8-12 weeks post-op to participate and may request approval from surgeon). Patients that receive care prior to the 4 week date post-concussion, may potentially still participate, depending on the care received. This will be up to the discretion of our physician or nurse practitioner, if they feel it has significantly altered their expected prognosis or recovery timeline that could affect the study results.

Prescription anticoagulant medication use such as warfarin, heparin, lovenox and others will exclude a patient from participation. Over the counter aspirin use will not exclude a patient. Vitals including blood pressure, SpO2 and heart rate are taken prior to participating in GyroStim to help screen for potential issues. As always, the well-being of our patients is primary concern, and if the physician or nurse practitioners feel participation in this study due to medications is an unnecessary risk, the patient will be excluded from consideration.

What this trial measures

Headache Impact Test (HIT-6)First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Subjective physical therapy questionnaire to evaluate extent of patient's headaches. Scores range from 36-78, with a higher score being more severe.
Post Concussion Symptom Scale (PCSS)First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Subjective patient questionnaire evaluating symptoms related to concussion. Scores range from 0-132, with higher scores indicating greater symptom severity.
Dizziness Handicap Inventory (DHI)First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Subjective physical therapy questionnaire to evaluate extent and impact of patient's complaints and symptoms of dizziness. Scores range from 0-100, with higher scores indicating greater symptom severity.
Neck Disability Index (NDI)First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Subjective physical therapy questionnaire to evaluate the extent and impact of a patient's complaints with neck pain and motion deficits. Scores range from 0-100%, with a higher percentage indicating more severe disability due to neck pain.
Functional Gait Assessment (FGA)First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Objective physical therapy assessment to evaluate patient's balance while ambulating. Scores range from 0-30, with high scores indicating a more normal gait, and lower scores indicating abnormality.
Modified Clinical Test of Sensory Interaction in Balance (CTSIB-m)First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Objective physical therapy assessment to evaluate a patient's balance while standing. Scoring is based off of time, from 0-120 seconds. The higher the score, the more normal a person's balance.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)First speech therapy visit and last speech therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Objective speech therapy test administered to evaluate patient's extent of cognitive deficits. Scores range from 200-800, and can be interpreted into percentiles. The higher the score, the better the individual's cognitive function.
Rivermeade Post-Concussion Symptom QuestionnaireFirst speech therapy visit and last speech therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Subjective speech therapy questionnaire to evaluate extent of patient's symptoms related to concussion. Scores range from 0-72, with a higher score indicating more severe symptoms.

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