What side effects are associated with this type of intervention?

Treatments for neurological disorders that involve interactive visual motor activities, visual and auditory processing, cognitive skills, and endurance training, such as the Bioness Integrated Therapy System (BITS) Touch Screen, generally have mild side effects. These may include temporary fatigue, mild headaches, eye strain, mental fatigue, or muscle soreness. These side effects are usually transient and not severe, making these therapies relatively safe for most patients.

What other types of research exist?

Promising alternatives to the Bioness Integrated Therapy System (BITS) Touch Screen for neurological disorders include: 1) Brain-Computer Interface (BCI) systems, which provide an alternative channel for communication and environmental interaction, particularly useful for patients with motor disabilities. 2) Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown benefits in improving sleep-related quality of life and psychological well-being, potentially aiding cognitive function. 3) Mindfulness-Based Stress Reduction (MBSR) programs, which focus on meditation practices to enhance self-regulation and cognitive skills. 4) Tai Chi and Qigong mind-body exercises, which have been shown to improve motor and non-motor functions, including cognitive skills and endurance, in patients with Parkinson's disease.

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BITS Visual Intervention for Traumatic Brain Injury

Q: What prior FDA approvals exist?

The FDA has approved several treatments for neurological disorders that involve interactive and cognitive rehabilitation methods. For instance, the Bioness Integrated Therapy System (BITS) Touch Screen is an FDA-approved device that uses interactive touchscreen technology to improve visual motor activities, visual and auditory processing, cognitive skills, and endurance training. Other similar FDA-approved treatments include various forms of transcranial magnetic stimulation (TMS) for depression and cognitive impairment, and deep brain stimulation (DBS) for Parkinson's disease, which also aim to enhance cognitive and motor functions through neuromodulation.

N/A

Waitlist Available

Led By Heidi Fagan, OTR/L

Research Sponsored by Gaylord Hospital, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admitted for inpatient rehabilitation

Must have an acute or subacute (diagnosed within the last 3 months) neurological diagnosis with a visual field deficit as verified by occupational therapist via confrontation testing

Must not have

Quadriparesis

Severe cognitive impairments: Unable to follow one step directions, inability to communicate pain, or to stop intervention if needed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to enrollment to determine eligibility. potential participants are screened within 72 hours of admission to the inpatient rehabilitation program.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special touchscreen device to help adults with vision problems from a neurological event. The device uses fun and challenging activities to improve their vision. The study compares this new method to traditional vision exercises to see which works better.

Who is the study for?

This trial is for adults over 18 with recent neurological issues causing visual field deficits, who can consent and follow simple instructions. They must be in rehab, able to use a touch screen with their arms, and sit for at least 30 minutes. It's not for those with unstable vitals, severe cognitive or physical impairments, certain heart conditions, legal blindness history, or very recent severe neurological events.

What is being tested?

The study compares traditional table top vision exercises against the BITS touchscreen technology in improving visual field awareness after a brain injury. Participants are split into two groups: one uses conventional methods while the other uses BITS tech during rehabilitation sessions.

What are the potential side effects?

Safety is monitored through reported adverse events; however specific side effects aren't listed as it's more about comparing effectiveness of different therapy types rather than medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently in a hospital for rehabilitation.

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I was diagnosed with a neurological condition affecting my vision in the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have weakness in all four limbs.

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I can follow simple instructions, communicate pain, and ask to stop a treatment if necessary.

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I have not had a severe neurological condition or stroke in the last 3 days.

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I have had severe vision problems or legal blindness in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to enrollment to determine eligibility. potential participants are screened within 72 hours of admission to the inpatient rehabilitation program.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to enrollment to determine eligibility. potential participants are screened within 72 hours of admission to the inpatient rehabilitation program.

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to enrollment to determine eligibility. potential participants are screened within 72 hours of admission to the inpatient rehabilitation program. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bells Test

Confrontation Testing

Kinetic Field Assessment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bioness Integrated Therapy System Visual InterventionExperimental Treatment1 Intervention

Intervention will includes six sessions using the Bioness Integrated Therapy System for 20 minutes using the programs of visual scanning, visual pursuits and/or visual motor.All activities will be conducted with an occupational therapist/investigator.

Group II: Table Top Visual InterventionActive Control1 Intervention

Interventions will include six, 20 minute sessions using pen and paper word search, scanning activities, and saccade visual training. All activities will be conducted with an occupational therapist/investigator.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for neurological disorders, such as the Bioness Integrated Therapy System (BITS) Touch Screen, utilize interactive visual motor activities, visual and auditory processing, cognitive skills, and endurance training. These interventions work by engaging multiple sensory and motor pathways, promoting neuroplasticity, and improving functional outcomes. Visual motor activities enhance coordination and spatial awareness, while visual and auditory processing tasks improve sensory integration. Cognitive skills training targets memory, attention, and problem-solving abilities, and endurance training boosts overall physical stamina. These mechanisms are crucial for patients as they help restore lost functions, enhance daily living activities, and improve quality of life.

Non-invasive, non-pharmacological/bio-technological interventions towards neurorestoration upshot after ischemic stroke, in adults-systematic, synthetic, literature review.A focus group study of therapists' views on using a novel neuroanimation virtual reality game to deliver intensive upper-limb rehabilitation early after stroke.An Exercise Mimetic Approach to Reduce Poststroke Deconditioning and Enhance Stroke Recovery.