RecruitingNot Applicable

GyroStim for Post Concussion Syndrome

United States128 participantsStarted 2026-03-16

Plain-language summary

The goal of this study is to evaluate the efficacy of using sensorimotor multi-axis automated rotational therapy (SMART) to help treat post concussion syndrome (PCS) in adults. The investigators hypothesize that patients who include SMART therapy as part of their treatment regimen will improve faster than patients who do not include SMART treatment. The investigators hypothesize that patients whose treatment approach includes SMART will improve to a greater extent in their primary outcome measures than patients whose treatment approach did not include SMART. The primary study endpoints are Post Concussion Symptom Scale (PCSS), Headache Impact Severity (HIT-6), Neck Disability Index (NDI), Dizziness Handicap Inventory (DHI), Functional Gait Assessment (FGA), Modified Clinical Test of Sensory Interaction in Balance (CTSIB-m), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), and the Rivermeade Post-Concussion Symptom Questionnaire. These assessments will be performed before, midway, and after intervention. Researchers will compare study endpoints to subjects that proceed with standard of care treatments in physical therapy (PT) and speech therapy/cognitive rehabilitation therapy (ST/CRT). All participants will complete baseline testing in both PT and ST/CRT, and will continue with treatment in each therapy once a week. Intervention subjects will also complete 10 SMART session utilizing GyroStim, at a frequency of 2, 3 or 4 times a week. Follow up testing will happen in PT and ST/CRT after completion of 10 SMART sessions, or during their 6th PT and ST/CRT visit. Statistical analysis will look compare groups to evaluate efficacy of SMART intervention, as well as evaluate efficacy of therapeutic frequency.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * A history of closed head injury and a current diagnosis of mTBI with persistent symptoms (≥ 4 weeks) consistent with persistent post-concussion syndrome (PPCS) or post-concussion syndrome (PCS) is the primary criteria for inclusion into the study. Subjects must also have a diagnosis of imbalance, dizziness or other relevant vestibular dysfunction. A diagnosis of relevant cognitive deficits or difficulties is required to qualify for ST/CRT. Any cognitive deficits or difficulties must be related to mTBI/concussion and must not be to the extent that would negate a subject's ability to consent themselves. Subjects must be at least 18 years of age and able to communicate verbally and be competent to consent. * 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 criteria: * 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, uncontrolle…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1The GyroStim trial is listed as Phase NA, which I understand means it's not a traditional drug trial — can you help me understand what that means for how much is already known about whether this device is safe and effective for post-concussion syndrome?
2This trial is measuring a wide range of outcomes including headaches, dizziness, balance, neck disability, and cognitive function using tools like the HIT-6 and RBANS — do my specific symptoms line up well enough with what they're studying to make this worth considering?
3Since the GyroStim is a motorized chair-based treatment, how demanding is the treatment schedule likely to be in terms of time and travel, and is that realistic given where I am in my recovery right now?
4Before thinking about a trial like this, should I first try any standard or established treatments for post-concussion syndrome, and would doing so affect whether I could even participate later?
5The trial measures balance and gait using tests like the Functional Gait Assessment and the CTSIB-m — if my balance symptoms aren't a major problem right now, does that change whether this trial might be a good fit for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Headache Impact Test (HIT-6)

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

Post Concussion Symptom Scale (PCSS)

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

Dizziness Handicap Inventory (DHI)

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

Neck Disability Index (NDI)

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

Functional Gait Assessment (FGA)

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

Modified Clinical Test of Sensory Interaction in Balance (CTSIB-m)

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

Trial details

NCT IDNCT07527663

SponsorNeuroscience Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Nichole J Siebert, MS

920-725-9373 nichole.siebert@neurosciencegroup.com

View on ClinicalTrials.gov More Post Concussion Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Headache Impact Test (HIT-6)

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

Post Concussion Symptom Scale (PCSS)

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

Dizziness Handicap Inventory (DHI)

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

Neck Disability Index (NDI)

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

Functional Gait Assessment (FGA)

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

Modified Clinical Test of Sensory Interaction in Balance (CTSIB-m)

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