GyroStim for Concussion

Overseen By Nichole J Siebert, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neuroscience Group

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Uncontrolled hypertension, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 3-6 weeks

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Benjamin Siebert, MD

Principal Investigator

Neuroscience Group

Are You a Good Fit for This Trial?

Inclusion Criteria

I am an adult with a history of concussion, ongoing symptoms for 4+ weeks, balance or dizziness issues, and cognitive problems related to my concussion.

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

Patients less than 12 weeks post-partum

Patients with severe claustrophobia

I am able to understand and agree to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants complete baseline testing in both physical therapy (PT) and speech therapy/cognitive rehabilitation therapy (ST/CRT)

1 week

1 visit (in-person)

Treatment

Participants receive standard of care treatment with PT and ST/CRT once a week, and intervention subjects receive additional SMART sessions 2-4 times a week for 10 sessions

3-6 weeks

6 visits (in-person) for PT and ST/CRT, 10 visits (in-person) for SMART

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SMART utilizing GyroStim device

How Is the Trial Designed?

Group I: PT & ST/CRT plus SMART up to three times a week Experimental Treatment 2 Interventions

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.

Group II: PT & ST/CRT plus SMART up to four times a week Experimental Treatment 2 Interventions

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.

Group III: PT & ST/CRT plus SMART twice a week Experimental Treatment 2 Interventions

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.

Group IV: PT & ST/CRT Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Neuroscience Group

Lead Sponsor