128 Participants NeededMy employer runs this trial

GyroStim for Concussion

TW
NJ
Overseen ByNichole J Siebert, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called SMART, which uses a device called the GyroStim to treat post-concussion syndrome (PCS). Researchers aim to determine if adding SMART therapy to regular physical and speech therapy can speed recovery and improve outcomes compared to regular therapy alone. The trial seeks adults who have experienced a concussion with ongoing symptoms such as dizziness or balance issues for at least four weeks. Participants will be divided into groups to compare regular therapy with therapy that includes SMART sessions. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could enhance recovery options for PCS.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on prescription anticoagulant medications like warfarin, you cannot participate. Over-the-counter aspirin is allowed.

What prior data suggests that the GyroStim device is safe for treating post concussion syndrome?

Research has shown that the GyroStim device, used in SMART therapy, is safe for people. The FDA has cleared the device, confirming its safety for treating conditions like concussions. Clinics have used it since 2010, demonstrating that it is generally well-tolerated. Studies have not identified any major safety issues with its use. As a non-invasive treatment, the GyroStim does not involve surgery or entering the body, which reduces the risk of side effects. Overall, evidence suggests that GyroStim is a safe option for treating post-concussion symptoms.12345

Why are researchers excited about this trial?

Researchers are excited about using the GyroStim device for concussion treatment because it introduces a dynamic form of therapy known as SMART (Sensory, Motor, and Adaptive Rehabilitation Technology). Unlike traditional treatments that primarily rely on physical and speech/cognitive rehabilitation therapy, GyroStim involves a rotating chair that stimulates the vestibular system, potentially accelerating recovery. This novel approach could enhance rehabilitation outcomes by targeting the brain's ability to adapt and reorganize, offering a promising new direction for concussion therapy.

What evidence suggests that SMART utilizing GyroStim device could be an effective treatment for post concussion syndrome?

Research has shown that the GyroStim device, used in a therapy called SMART, can accelerate recovery from post-concussion syndrome. In this trial, participants will receive different treatment combinations. Some will undergo standard care, including physical therapy and speech therapy/cognitive rehabilitation therapy. Others will receive these standard therapies plus SMART sessions with the GyroStim device at varying frequencies. Studies have found that patients using GyroStim recover up to eight times faster than those relying solely on traditional therapies. More frequent use of GyroStim results in even quicker recovery. Clinical evidence suggests that incorporating GyroStim into treatment plans significantly speeds up recovery and reduces symptoms. These findings make it a promising option for those facing post-concussion challenges.12567

Who Is on the Research Team?

BS

Benjamin Siebert, MD

Principal Investigator

Neuroscience Group

Are You a Good Fit for This Trial?

This trial is for adults (18+) with ongoing symptoms from a concussion or mild traumatic brain injury lasting at least 4 weeks, who have balance issues, dizziness, or related cognitive problems. People are excluded if they have certain medical conditions like uncontrolled seizures, severe anxiety/depression, recent surgery, pregnancy, or can't give consent.

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.
See 25 more

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

Trial Overview

The study compares standard physical and speech/cognitive therapy to the same therapies plus SMART using the GyroStim device—a machine that rotates people in different directions to help with recovery. Participants are randomly assigned to either group.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: PT & ST/CRT plus SMART up to three times a weekExperimental Treatment2 Interventions
Group II: PT & ST/CRT plus SMART up to four times a weekExperimental Treatment2 Interventions
Group III: PT & ST/CRT plus SMART twice a weekExperimental Treatment2 Interventions
Group IV: PT & ST/CRTExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Neuroscience Group

Lead Sponsor

Citations

Clinical Evidence | Concussion and mTBI recovery ...

Higher treatment frequency with GyroStim was significantly associated with faster rehabilitation. • GyroStim treatment markedly accelerated recovery compared ...

Ver. 3/10/2025 Page 1 of 8 Subject Initials ___________

The data will be used to establish the effectiveness of GyroStim for post- concussion syndrome rehabilitation. To collect the necessary data for ...

GyroStim Associated With Up to 8x Faster Rehabilitation Rate

This clinical data provides new evidence that GyroStim is associated with significantly faster rates of rehabilitation compared with ...

GyroStim for Post Concussion Syndrome - MedPath

The goal of this study is to evaluate the efficacy of using sensorimotor multi-axis automated rotational therapy (SMART) to help treat post ...

Sub-Symptom Threshold Balance Training Facilitates Post ...

All individual template scores increased, including those on the most complex template, which rose from 55.76% to 80.20%. The patient also ...

6.

gyrostim.com

gyrostim.com/

GyroStim | FDA-Cleared Breakthrough Device for ...

Proven safe. Proven effective. Proven transformative. · Effective: Up to 8x faster rehabilitation rate for concussion recovery than conventional therapies alone.

Wearable technology to characterize and treat mild traumatic ...

This study is a single-blinded randomized controlled trial involving 100 individuals experiencing persistent symptoms from subacute and chronic ...