We completed two successful clinical trials, in the US and Europe, please see publications below. Our clinical trials determine the extent to which ‘playing’ PAGE games and exercises, with or without our wearable hand movement device, will:
- improve patients’ physical limb movements;
- produce volumetric brain changes; and
- support cognitive improvement.
Clinical trials comply with a set of rules called a protocol. Our protocol includes guidelines on how the trial will be conducted, safeguards for participants, inclusion/exclusion criteria, PAGE ‘game-play’ procedures, number of ‘game-play’ sessions and duration of the trial. All survivors participate only after signing informed consent about the purpose and procedures of the trial, number of sessions to be ‘played’, types of measurements used to record motor and/or cognitive change and use of data.
3DPreMotorSkill Technologies, LLC (3DPreMotor) conducts clinical trials pursuant to detailed budgets. Clinical trial information is always provided to survivor-participants i.e. individuals who have had a stroke and/or traumatic brain injury (ABI).
Our clinical trials include ABI survivor-participants ‘playing’ entertaining and useful Pre-Action Games & Exercises (PAGE). PAGE games and exercises are designed to help ABI survivors turn the page to improved planning for physical actions.
3DPreMotor-PAGE clinical trials follow published standards. The standards are in place to protect patients and produce reliable/reproducible results.
Clinical trials in many countries are required to be approved and monitored by an Institutional Review Board (IRB). An IRB is an independent committee of health care professionals, business and community personnel and others. It ensures the clinical trial is ethical and participants are protected.
Disclosures on tests and measurements are part of informed consent. For example, explanations are given to survivors on subjects such as magnetic resonance imaging (MRI), physical power measurements, upper extremity goniometric measurements, active range of motion for abduction, adduction, flexion, extension, tests to evaluate participants’ handling of small and large objects, functional independence measurements to assess independence in basic self-care, mobility, communication, psychosocial adjustment and cognitive functioning.
3DPreMotor budgets are based on estimated costs. Clinical trial and/or development costs can change. In the event a clinical trial is not fully funded by donations, 3DPreMotor, in its sole and exclusive discretion, will use donations for selected budget items. All donations are final, the sole the exclusive property of 3DPreMotor and will be used, not refunded. A sample detailed budget appears in this section, please scroll down.
Reports on use of donated funds will be made semi-annually, beginning June 2018, on 3DPreMotor’s website, neurojungle.com. Donations will be reported as taxable income to 3DPreMotor and are not tax deductible by donors. 3DPreMotor is a research and development company. It does not engage in sales, nevertheless 3DPreMotor is a business not a charitable entity.