GyroStim for Concussion
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Testing
Participants complete baseline testing in both physical therapy (PT) and speech therapy/cognitive rehabilitation therapy (ST/CRT)
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
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
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
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.
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.
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.
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.
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 ...
3.
finance.yahoo.com
finance.yahoo.com/news/clinical-breakthrough-concussion-gyrostim-associated-151500439.htmlGyroStim 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 ...
4.
trial.medpath.com
trial.medpath.com/clinical-trial/dc25884cbd8cc054/nct07527663-smart-post-concussion-syndrome-rehabilitationGyroStim 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 ...
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 ...
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