Post Concussion SyndromeNCT07527663
GyroStim for Post Concussion Syndrome
A study testing Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device and Physical therapy and speech therapy/cognitive rehabilitation therapy in people with Post Concussion Syndrome, run by Neuroscience Group at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Concussion Syndrome
- What is being tested?
- Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device and Physical therapy and speech therapy/cognitive rehabilitation therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Neuroscience Group
Appleton, Wisconsin, 54915
Nichole J Siebert, MS, 920-725-9373, nichole.siebert@neurosciencegroup.com
Taylor Weuve, MBA, 920-725-9373, taylor.weuve@neurosciencegroup.com
About this study
Official title: Effectiveness of Sensorimotor Multi-axis Automated Rotational Therapy (SMART) for Post-Concussion Syndrome Rehabilitation
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.
Read more
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.
- Conditions
- Post Concussion Syndrome
- Being tested
- Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device, Physical therapy and speech therapy/cognitive rehabilitation therapy
- Keywords
- Post Concussion Syndrome, Sensorimotor Multi-axis Automated Rotational Therapy (SMART), GyroStim
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim deviceDevice
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.
Physical therapy and speech therapy/cognitive rehabilitation therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PT & ST/CRT | Other | Standard of care treatment for post concussion syndrome. Includes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week for 5 weeks or 6 total visits. Receives: Other: Physical therapy and speech therapy/cognitive rehabilitation therapy |
| PT & ST/CRT plus SMART twice a week | Experimental | Includes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week plus SMART twice a week for 10 sessions. Last PT \& ST/CRT occur once SMART sessions are completed. Receives: Device: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device; Other: Physical therapy and speech therapy/cognitive rehabilitation therapy |
| PT & ST/CRT plus SMART up to three times a week | Experimental | Includes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week plus SMART up to three times a week for 10 sessions. Last PT \& ST/CRT occur once SMART sessions are completed. Receives: Device: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device; Other: Physical therapy and speech therapy/cognitive rehabilitation therapy |
| PT & ST/CRT plus SMART up to four times a week | Experimental | Includes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week plus SMART sessions up to four times a week for 10 sessions. Last PT \& ST/CRT occur once SMART sessions are completed. Receives: Device: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device; Other: Physical therapy and speech therapy/cognitive rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Impact Test (HIT-6)
Subjective physical therapy questionnaire to evaluate extent of patient's headaches. Scores range from 36-78, with a higher score being more severe.
Measured: 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)
Subjective patient questionnaire evaluating symptoms related to concussion. Scores range from 0-132, with higher scores indicating greater symptom severity.
Measured: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Dizziness Handicap Inventory (DHI)
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.
Measured: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Neck Disability Index (NDI)
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.
Measured: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Functional Gait Assessment (FGA)
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.
Measured: 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)
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.
Measured: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
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.
Measured: First speech therapy visit and last speech therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Rivermeade Post-Concussion Symptom Questionnaire
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.
Measured: First speech therapy visit and last speech therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start16 Mar 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Post Concussion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Two primary groups: one being standard of care that would include physical therapy (PT) and speech therapy/cognitive rehabilitation therapy (ST/CRT); two being standard of care (PT and ST/CRT) plus SMART sessions at different frequencies.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuroscience Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Siebert, MD, Study director, Neuroscience Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527663
- Sponsor's protocol ID
- 2025-0293
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Sharing will likely be dependent on results and findings.
Publications
Yang CC, Tu YK, Hua MS, Huang SJ. The association between the postconcussion symptoms and clinical outcomes for patients with mild traumatic brain injury. J Trauma. 2007 Mar;62(3):657-63. doi: 10.1097/01.ta.0000203577.68764.b8.
PubMed 17414343Maher, K., & Hall, C. (2026). Comparative Clinical Outcomes of Physical Therapy Versus Physical Therapy Combined With GyroStim for Treatment of Post-Concussion Syndrome: A Retrospective Case Series [Unpublished manuscript]. ANOVA Healthcare, North Carolina.
Heyser, B. (2023). Unpublished data collection from retrospective study utilizing GyroStim patients with concussion [Unpublished raw data]. Heyser Chiropractic Neurology @ The Brain Center, Tallahassee, FL.
Hall CD, Herdman SJ, Whitney SL, Anson ER, Carender WJ, Hoppes CW, Cass SP, Christy JB, Cohen HS, Fife TD, Furman JM, Shepard NT, Clendaniel RA, Dishman JD, Goebel JA, Meldrum D, Ryan C, Wallace RL, Woodward NJ. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Updated Clinical Practice Guideline From the Academy of Neurologic Physical Therapy of the American Physical Therapy Association. J Neurol Phys Ther. 2022 Apr 1;46(2):118-177. doi: 10.1097/NPT.0000000000000382.
PubMed 34864777Denson K, Morgan D, Cunningham R, Nigliazzo A, Brackett D, Lane M, Smith B, Albrecht R. Incidence of venous thromboembolism in patients with traumatic brain injury. Am J Surg. 2007 Mar;193(3):380-3; discussion 383-4. doi: 10.1016/j.amjsurg.2006.12.004.
PubMed 17320539Suleiman A, Lithgow BJ, Anssari N, Ashiri M, Moussavi Z, Mansouri B. Correlation between Ocular and Vestibular Abnormalities and Convergence Insufficiency in Post-Concussion Syndrome. Neuroophthalmology. 2019 Oct 9;44(3):157-167. doi: 10.1080/01658107.2019.1653325. eCollection 2020 Jun.
PubMed 32395167Silverberg ND, Iverson GL; ACRM Brain Injury Special Interest Group Mild TBI Task Force members:; Cogan A, Dams-O-Connor K, Delmonico R, Graf MJP, Iaccarino MA, Kajankova M, Kamins J, McCulloch KL, McKinney G, Nagele D, Panenka WJ, Rabinowitz AR, Reed N, Wethe JV, Whitehair V; ACRM Mild TBI Diagnostic Criteria Expert Consensus Group:; Anderson V, Arciniegas DB, Bayley MT, Bazarian JJ, Bell KR, Broglio SP, Cifu D, Davis GA, Dvorak J, Echemendia RJ, Gioia GA, Giza CC, Hinds SR 2nd, Katz DI, Kurowski BG, Leddy JJ, Sage NL, Lumba-Brown A, Maas AI, Manley GT, McCrea M, Menon DK, Ponsford J, Putukian M, Suskauer SJ, van der Naalt J, Walker WC, Yeates KO, Zafonte R, Zasler ND, Zemek R. The American Congress of Rehabilitation Medicine Diagnostic Criteria for Mild Traumatic Brain Injury. Arch Phys Med Rehabil. 2023 Aug;104(8):1343-1355. doi: 10.1016/j.apmr.2023.03.036. Epub 2023 May 19.
PubMed 37211140Rytter HM, Graff HJ, Henriksen HK, Aaen N, Hartvigsen J, Hoegh M, Nisted I, Naess-Schmidt ET, Pedersen LL, Schytz HW, Thastum MM, Zerlang B, Callesen HE. Nonpharmacological Treatment of Persistent Postconcussion Symptoms in Adults: A Systematic Review and Meta-analysis and Guideline Recommendation. JAMA Netw Open. 2021 Nov 1;4(11):e2132221. doi: 10.1001/jamanetworkopen.2021.32221.
PubMed 34751759Patricios JS, Schneider KJ, Dvorak J, Ahmed OH, Blauwet C, Cantu RC, Davis GA, Echemendia RJ, Makdissi M, McNamee M, Broglio S, Emery CA, Feddermann-Demont N, Fuller GW, Giza CC, Guskiewicz KM, Hainline B, Iverson GL, Kutcher JS, Leddy JJ, Maddocks D, Manley G, McCrea M, Purcell LK, Putukian M, Sato H, Tuominen MP, Turner M, Yeates KO, Herring SA, Meeuwisse W. Consensus statement on concussion in sport: the 6th International Conference on Concussion in Sport-Amsterdam, October 2022. Br J Sports Med. 2023 Jun;57(11):695-711. doi: 10.1136/bjsports-2023-106898.
PubMed 37316210Murray DA, Meldrum D, Lennon O. Can vestibular rehabilitation exercises help patients with concussion? A systematic review of efficacy, prescription and progression patterns. Br J Sports Med. 2017 Mar;51(5):442-451. doi: 10.1136/bjsports-2016-096081. Epub 2016 Sep 21.
PubMed 27655831Laborey M, Masson F, Ribereau-Gayon R, Zongo D, Salmi LR, Lagarde E. Specificity of postconcussion symptoms at 3 months after mild traumatic brain injury: results from a comparative cohort study. J Head Trauma Rehabil. 2014 Jan-Feb;29(1):E28-36. doi: 10.1097/HTR.0b013e318280f896.
PubMed 23474878Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613.
PubMed 19996233Hoffer ME, Balaban C, Gottshall K, Balough BJ, Maddox MR, Penta JR. Blast exposure: vestibular consequences and associated characteristics. Otol Neurotol. 2010 Feb;31(2):232-6. doi: 10.1097/MAO.0b013e3181c993c3.
PubMed 20009782Giza CC, Hovda DA. The Neurometabolic Cascade of Concussion. J Athl Train. 2001 Sep;36(3):228-235.
PubMed 12937489Ellis MJ, Leddy J, Willer B. Multi-Disciplinary Management of Athletes with Post-Concussion Syndrome: An Evolving Pathophysiological Approach. Front Neurol. 2016 Aug 24;7:136. doi: 10.3389/fneur.2016.00136. eCollection 2016.
PubMed 27605923
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sensorimotor Multi-axis Automated Rotational Therapy (SMART) for Post-Concussion Syndrome Rehabilitation
- ClinicalTrials.gov ID
- NCT07527663
- Acronym / sponsor ID
- 2025-0293
- Conditions
- Post Concussion Syndrome
- Keywords
- Post Concussion Syndrome, Sensorimotor Multi-axis Automated Rotational Therapy (SMART), GyroStim
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Neuroscience GroupUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Two primary groups: one being standard of care that would include physical therapy (PT) and speech therapy/cognitive rehabilitation therapy (ST/CRT); two being standard of care (PT and ST/CRT) plus SMART sessions at different frequencies.
| Arm | Type | Receives |
|---|---|---|
| PT & ST/CRT | Other | Other: Physical therapy and speech therapy/cognitive rehabilitation therapyStandard of care treatment for post concussion syndrome. Includes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week for 5 weeks or 6 total visits. |
| PT & ST/CRT plus SMART twice a week | Experimental | Device: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device, Other: Physical therapy and speech therapy/cognitive rehabilitation therapyIncludes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week plus SMART twice a week for 10 sessions. Last PT \& ST/CRT occur once SMART sessions are completed. |
| PT & ST/CRT plus SMART up to three times a week | Experimental | Device: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device, Other: Physical therapy and speech therapy/cognitive rehabilitation therapyIncludes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week plus SMART up to three times a week for 10 sessions. Last PT \& ST/CRT occur once SMART sessions are completed. |
| PT & ST/CRT plus SMART up to four times a week | Experimental | Device: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device, Other: Physical therapy and speech therapy/cognitive rehabilitation therapyIncludes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week plus SMART sessions up to four times a week for 10 sessions. Last PT \& ST/CRT occur once SMART sessions are completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim deviceGyroStim 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. | Device | PT & ST/CRT plus SMART twice a week, PT & ST/CRT plus SMART up to four times a week, PT & ST/CRT plus SMART up to three times a week |
| Physical therapy and speech therapy/cognitive rehabilitation therapyStandard 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. | Other | PT & ST/CRT, PT & ST/CRT plus SMART twice a week, PT & ST/CRT plus SMART up to four times a week, PT & ST/CRT plus SMART up to three times a week |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 17414343Yang CC, Tu YK, Hua MS, Huang SJ. The association between the postconcussion symptoms and clinical outcomes for patients with mild traumatic brain injury. J Trauma. 2007 Mar;62(3):657-63. doi: 10.1097/01.ta.0000203577.68764.b8.
- BackgroundMaher, K., & Hall, C. (2026). Comparative Clinical Outcomes of Physical Therapy Versus Physical Therapy Combined With GyroStim for Treatment of Post-Concussion Syndrome: A Retrospective Case Series [Unpublished manuscript]. ANOVA Healthcare, North Carolina.
- BackgroundHeyser, B. (2023). Unpublished data collection from retrospective study utilizing GyroStim patients with concussion [Unpublished raw data]. Heyser Chiropractic Neurology @ The Brain Center, Tallahassee, FL.
- Background: PubMed 34864777Hall CD, Herdman SJ, Whitney SL, Anson ER, Carender WJ, Hoppes CW, Cass SP, Christy JB, Cohen HS, Fife TD, Furman JM, Shepard NT, Clendaniel RA, Dishman JD, Goebel JA, Meldrum D, Ryan C, Wallace RL, Woodward NJ. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Updated Clinical Practice Guideline From the Academy of Neurologic Physical Therapy of the American Physical Therapy Association. J Neurol Phys Ther. 2022 Apr 1;46(2):118-177. doi: 10.1097/NPT.0000000000000382.
- Background: PubMed 17320539Denson K, Morgan D, Cunningham R, Nigliazzo A, Brackett D, Lane M, Smith B, Albrecht R. Incidence of venous thromboembolism in patients with traumatic brain injury. Am J Surg. 2007 Mar;193(3):380-3; discussion 383-4. doi: 10.1016/j.amjsurg.2006.12.004.
- Background: PubMed 32395167Suleiman A, Lithgow BJ, Anssari N, Ashiri M, Moussavi Z, Mansouri B. Correlation between Ocular and Vestibular Abnormalities and Convergence Insufficiency in Post-Concussion Syndrome. Neuroophthalmology. 2019 Oct 9;44(3):157-167. doi: 10.1080/01658107.2019.1653325. eCollection 2020 Jun.
- Background: PubMed 37211140Silverberg ND, Iverson GL; ACRM Brain Injury Special Interest Group Mild TBI Task Force members:; Cogan A, Dams-O-Connor K, Delmonico R, Graf MJP, Iaccarino MA, Kajankova M, Kamins J, McCulloch KL, McKinney G, Nagele D, Panenka WJ, Rabinowitz AR, Reed N, Wethe JV, Whitehair V; ACRM Mild TBI Diagnostic Criteria Expert Consensus Group:; Anderson V, Arciniegas DB, Bayley MT, Bazarian JJ, Bell KR, Broglio SP, Cifu D, Davis GA, Dvorak J, Echemendia RJ, Gioia GA, Giza CC, Hinds SR 2nd, Katz DI, Kurowski BG, Leddy JJ, Sage NL, Lumba-Brown A, Maas AI, Manley GT, McCrea M, Menon DK, Ponsford J, Putukian M, Suskauer SJ, van der Naalt J, Walker WC, Yeates KO, Zafonte R, Zasler ND, Zemek R. The American Congress of Rehabilitation Medicine Diagnostic Criteria for Mild Traumatic Brain Injury. Arch Phys Med Rehabil. 2023 Aug;104(8):1343-1355. doi: 10.1016/j.apmr.2023.03.036. Epub 2023 May 19.
- Background: PubMed 34751759Rytter HM, Graff HJ, Henriksen HK, Aaen N, Hartvigsen J, Hoegh M, Nisted I, Naess-Schmidt ET, Pedersen LL, Schytz HW, Thastum MM, Zerlang B, Callesen HE. Nonpharmacological Treatment of Persistent Postconcussion Symptoms in Adults: A Systematic Review and Meta-analysis and Guideline Recommendation. JAMA Netw Open. 2021 Nov 1;4(11):e2132221. doi: 10.1001/jamanetworkopen.2021.32221.
- Background: PubMed 37316210Patricios JS, Schneider KJ, Dvorak J, Ahmed OH, Blauwet C, Cantu RC, Davis GA, Echemendia RJ, Makdissi M, McNamee M, Broglio S, Emery CA, Feddermann-Demont N, Fuller GW, Giza CC, Guskiewicz KM, Hainline B, Iverson GL, Kutcher JS, Leddy JJ, Maddocks D, Manley G, McCrea M, Purcell LK, Putukian M, Sato H, Tuominen MP, Turner M, Yeates KO, Herring SA, Meeuwisse W. Consensus statement on concussion in sport: the 6th International Conference on Concussion in Sport-Amsterdam, October 2022. Br J Sports Med. 2023 Jun;57(11):695-711. doi: 10.1136/bjsports-2023-106898.
- Background: PubMed 27655831Murray DA, Meldrum D, Lennon O. Can vestibular rehabilitation exercises help patients with concussion? A systematic review of efficacy, prescription and progression patterns. Br J Sports Med. 2017 Mar;51(5):442-451. doi: 10.1136/bjsports-2016-096081. Epub 2016 Sep 21.
- Background: PubMed 23474878Laborey M, Masson F, Ribereau-Gayon R, Zongo D, Salmi LR, Lagarde E. Specificity of postconcussion symptoms at 3 months after mild traumatic brain injury: results from a comparative cohort study. J Head Trauma Rehabil. 2014 Jan-Feb;29(1):E28-36. doi: 10.1097/HTR.0b013e318280f896.
- Background: PubMed 19996233Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613.
- Concussion. American Association of Neurological SurgeonsLink provided by the sponsor.
- ConcussionLink provided by the sponsor.
- Management and Rehabilitation of Post-Acute Mild Traumatic Brain Injury Work GroupLink provided by the sponsor.
- Post Concussive SyndromeLink provided by the sponsor.
- Shirley Ryan Lab: Functional Gate AssessmentLink provided by the sponsor.
- Shirley Ryan Lab: m-CTSIBLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Sharing will likely be dependent on results and findings.
Related trials for Post Concussion Syndrome
Not yet recruiting
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
Patients With Persistent Post-concussion Symptoms
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Recruiting
Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury
Traumatic Brain Injury
Active, not recruiting
Move&Connect: A Program for Youth With Concussion and Their Caregivers.
Post-Concussion Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Siebert, MD study director
Neuroscience Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device and Physical therapy and speech therapy/cognitive rehabilitation therapy in people with Post Concussion Syndrome, run by Neuroscience Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nichole J Siebert, MS (920-725-9373, nichole.siebert@neurosciencegroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07527663, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.