NCT07527663 · Neuroscience Group
GyroStim for Post Concussion Syndrome
What this study is about
The goal of this study is to evaluate the effectiveness 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.
View original scientific description
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.
Interventions
DEVICE
Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device
GyroStim is a sensorimotor multi-axis automated rotational therapy (SMART) and used to stimulate, challenge, and improve the functional performance of the human sensorimotor system. GyroStim software allows the clinician to select and run specific, individual programs in a series of runs that present incrementally increasing intensity, duration, and cognitive challenge to help promote functional gains and achieve patient rehabilitation. GyroStim consists of a chair that is mounted to two rotational frames that are run by individual electric motors. Each axis can spin up to 360 degrees separately or simultaneously. The chair, rotational frames and pod are enclosed within a circular steel and polycarbonate frame. There are numerous safety features and an integrated targeting system subjects hit with a laser pointer to help integrate visual, vestibular and sensorimotor coordination.
OTHER
Physical therapy and speech therapy/cognitive rehabilitation therapy
Standard of care for all participants will include physical therapy and speech therapy once a week to address many symptom-based issues that are often associated with post concussion syndrome. Physical therapy will address vestibular, oculomotor, headache, and other muscoloskeletal concerns. Sessions will include patient history, evaluation, assessment, manual therapy, exercises, patient education and home exercise program. Speech therapy will address cognitive concerns which may include communication, memory, and various executive functioning aspects of the brain. Sessions will include patient history, assessment, cognitive tasks and challenges, education and home exercise program.
Primary outcome measures
Headache Impact Test (HIT-6)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 Questionnaire
Time frame: First 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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, 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.
- 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.
Where
- Appleton, Wisconsin
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 10, 2026 · Source of record for eligibility and locations