GyroStim SMART rotational therapy for post-concussion syndrome

Effectiveness of Sensorimotor Multi-axis Automated Rotational Therapy (SMART) for Post-Concussion Syndrome Rehabilitation

This project will test whether adding GyroStim sensorimotor multi-axis rotational therapy (SMART) helps adults with persistent post-concussion syndrome recover faster and more fully.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Neuroscience Group (Academic / other)
• Locations: 1 site (Appleton, Wisconsin)
• Trial ID: NCT07527663 on ClinicalTrials.gov

What this trial studies

This interventional program adds sensorimotor multi-axis automated rotational therapy (SMART) using the GyroStim device to usual care including physical therapy and speech/cognitive rehabilitation for adults with persistent post-concussion syndrome. Participants with vestibular symptoms and cognitive difficulties related to a prior closed head injury receive GyroStim sessions alongside standard therapies and are compared to patients whose care does not include SMART. Outcomes are measured with symptom, headache, neck, dizziness, gait, balance, and cognitive scales including PCSS, HIT-6, NDI, DHI, FGA, CTSIB-m, RBANS, and the Rivermead Post-Concussion Questionnaire. The investigators hypothesize that adding SMART will speed recovery and produce larger improvements on these validated measures.

Who should consider this trial

Good fit: Adults (18+) with a history of closed head injury, at least four weeks of persistent post-concussion symptoms, and documented imbalance, dizziness, or related vestibular dysfunction (and cognitive deficits if qualifying for ST/CRT) are ideal candidates.

Not a fit: Patients without vestibular symptoms, those already undergoing similar physical therapy regimens, or individuals whose cognitive impairment prevents informed consent are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, adding GyroStim SMART therapy could shorten recovery time and reduce symptom burden for adults with persistent post-concussion syndrome and vestibular dysfunction.

How similar studies have performed: Some vestibular and sensorimotor rehabilitation approaches have shown benefit for post-concussion vestibular symptoms, but evidence specific to GyroStim/SMART is limited and this approach remains relatively novel.

Eligibility criteria

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, increased risk of depression or anxiety, as determined by a score of 3 or more on either subset of the Patient Health Questionnaire-4 \[(PHQ-4) see Appendix J\], 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.

Where this trial is running

Appleton, Wisconsin

• Neuroscience Group — Appleton, Wisconsin, United States (Recruiting)

Study contacts

• Study coordinator: Nichole J Siebert, MS

Conditions Post Concussion Syndrome; Sensorimotor Multi-axis Automated Rotational Therapy; GyroStim