GyroStim for Post Concussion Syndrome

NCT07527663 | Recruiting FDA Device

• 1 other identifier: 2025-0293
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Concussion Syndrome

Keywords

Post Concussion Syndrome; Sensorimotor Multi-axis Automated Rotational Therapy (SMART); GyroStim

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

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

Study Arms (4)

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.

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.

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.

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.

Device: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device; Other: Physical therapy and speech therapy/cognitive rehabilitation therapy

Interventions

Physical therapy and speech therapy/cognitive rehabilitation therapy OTHER

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.

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

Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuroscience Group: lead

Study Sites (1)

Neuroscience Group

Appleton, Wisconsin, 54915, United States

RECRUITING

Related Publications (15)

• Yang, C. C., Tu, Y. K., Hua, M. S., & Huang, S. J. (2007). The Association Between Post-Concussion Symptoms and Clinical Outcomes for Patients With Mild Traumatic Brain Injury. Journal of Trauma, 62(3), 657-663.

  BACKGROUND

• Maher, 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.

  BACKGROUND

• 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.

  BACKGROUND

• Hall, C. D., Herdman, S. J., Whitney, S. L., Cass, S. P., Clendaniel, R. A., Fife, T. D., Furman, J. M., et al. (2022). Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: Updated Clinical Practice Guideline from the American Physical Therapy Association. Journal of Neurologic Physical Therapy, 46(2), 118-177.

  BACKGROUND

• Denson 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.

  PMID: 17320539 BACKGROUND

• Suleiman 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.

  PMID: 32395167 BACKGROUND

• Silverberg 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.

  PMID: 37211140 BACKGROUND

• Rytter 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.

  PMID: 34751759 BACKGROUND

• Patricios 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.

  PMID: 37316210 BACKGROUND

• Murray 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.

  PMID: 27655831 BACKGROUND

• Laborey 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.

  PMID: 23474878 BACKGROUND

• Kroenke 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.

  PMID: 19996233 BACKGROUND

• Hoffer 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.

  PMID: 20009782 BACKGROUND

• Giza CC, Hovda DA. The Neurometabolic Cascade of Concussion. J Athl Train. 2001 Sep;36(3):228-235.

  PMID: 12937489 BACKGROUND

• Ellis 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.

  PMID: 27605923 BACKGROUND

Related Links

• Concussion. American Association of Neurological Surgeons
• Concussion
• Management and Rehabilitation of Post-Acute Mild Traumatic Brain Injury Work Group
• Post Concussive Syndrome
• Shirley Ryan Lab: Functional Gate Assessment
• Shirley Ryan Lab: m-CTSIB
• American Medical Society for Sports Medicine Position Statement: Concussion in Sport
• Consensus Statement on Concussion in Sport: 6th International Conference on Concussion in Sport

MeSH Terms

Conditions

Post-Concussion Syndrome

Interventions

Physical Therapy Modalities; Speech Therapy

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Rehabilitation of Speech and Language Disorders; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Benjamin Siebert, MD

  Neuroscience Group

  STUDY DIRECTOR

Central Study Contacts

Nichole J Siebert, MS

CONTACT

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

Taylor Weuve, MBA

CONTACT

920-725-9373; taylor.weuve@neurosciencegroup.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 14, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)