Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07527663

GyroStim for Post Concussion Syndrome

Led by Neuroscience Group · Updated on 2026-04-21

128

Participants Needed

1

Research Sites

80 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

GyroStim for Post Concussion Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • History of closed head injury with mild traumatic brain injury diagnosis and persistent symptoms for 4 weeks or more
  • Diagnosis of imbalance, dizziness, or relevant vestibular dysfunction
  • Diagnosis of cognitive deficits or difficulties related to mTBI suitable for speech/cognitive therapy
  • Able to communicate verbally and provide informed consent
  • May have received prior concussion care but not currently receiving physical or speech therapy elsewhere
  • Have not previously received SMART therapy for the current head injury
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Not competent to provide consent
  • Concussion occurred less than 4 weeks prior to initial visit
  • Weighing more than 400 pounds or taller than 7 feet
  • Unable to communicate verbally
  • Pregnant or less than 12 weeks postpartum
  • Active benign paroxysmal positional vertigo (BPPV)
  • Severe claustrophobia
  • Uncontrolled hypertension or seizures
  • High risk of depression or anxiety based on Patient Health Questionnaire-4
  • Conditions such as ankylosing spondylitis, postural cardiac issues, active cervical radiculopathy, cauda equina symptoms, Chiari malformation Type II-IV, detached retina
  • Severe cervical range of motion limitations
  • Neurological disorders including multiple sclerosis and Parkinson's disease
  • Severe depression or anxiety
  • Hearing impairments or significant vision dysfunction
  • Recent upper extremity injury
  • Use of prescription anticoagulants such as warfarin, heparin, or lovenox
  • Post-surgical patients less than 8-12 weeks post-operation without approval
  • Other conditions deemed unsafe by physician or nurse practitioner

AI-Screening

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Trial Site Locations

Total: 1 location

1

Neuroscience Group

Appleton, Wisconsin, United States, 54915

Actively Recruiting

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Research Team

N

Nichole J Siebert, MS

CONTACT

T

Taylor Weuve, MBA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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GyroStim for Post Concussion Syndrome | DecenTrialz