Helius Composite 2017 Portable
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Layout table for study information Study Type : Interventional (Clinical Trial) ActualEnrollment : 122 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: Double Blind, Randomized, Sham Controlled Study of Safety and Effectiveness of the Portable Neuromodulation Stimulator (PoNS) Device for Cranial Nerve Noninvasive Neuromodulation Training for Chronic Balance Deficit Due to Mild/Moderate TBI Study Start Date : August 2015 Actual Primary Completion Date : August 18, 2017 Actual Study Completion Date : August 18, 2017 Resource links provided by the National Library of Medicine MedlinePlus related topics: Traumatic Brain Injury Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease U.S. FDA Resources Arms and Interventions Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Arm Intervention/treatment Experimental: PoNS DeviceCranial nerve non-invasive neuromodulation via PoNS device. The system delivers 19 V pulses to the tongue (a nominal 5.5 kilo-ohm load). Device: Cranial nerve non-invasive neuromodulation via PoNS deviceThe PoNS is a medical device worn around the neck. The controller contains the pulse generator and a user interface. The mouthpiece, held to the top of the tongue, contains 143 circular gold electrodes that deliver a mild, controlled electric stimulation to the subject. While the subject is receiving stimulation, they will perform increasingly difficult balance, posture, gait, and movement control tasks designed to challenge existing abilities. Each training session takes approximately one hour to complete, and is separated by an interval of 2-2.5 hours. Sham Comparator: Sham PoNS DeviceThe sham control device appears physically identical but uses a modified stimulus waveform parameter set designed to elicit a mild tactile sensation while minimizing the net energy delivered, thereby providing minimal, if any, cranial nerve non-invasive neuromodulation via PoNS device Device: Sham PoNS deviceThe PoNS is a medical device worn around the neck. The controller contains the pulse generator and a user interface. The mouthpiece, held to the top of the tongue, contains 143 circular gold electrodes that deliver a mild, controlled electric stimulation to the subject. The sham control device is physically identical but uses a modified stimulus waveform parameter set designed to elicit a mild tactile sensation while minimizing the net energy delivered, minimizing any neuromodulatory effect. While the subject is receiving stimulation, they will perform increasingly difficult balance, posture, gait, and movement control tasks designed to challenge existing abilities. Each training session takes approximately one hour to complete, and is separated by an interval of 2-2.5 hours. Outcome Measures Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Primary Outcome Measures : Response to treatment defined as an 8 point change in the Sensory Organization Test (SOT) from baseline [ Time Frame: 5 weeks after the start of the intervention ]The SOT is an objective, automated measure of sensory-motor integration that evaluates the functional contribution of the somatosensory, visual, and vestibular components of balance. A composite score is calculated and compared with a database normalized for age and height. Secondary Outcome Measures : Increase in SOT score from pre-training SOT score at the end of 2 weeks in lab training [ Time Frame: Two weeks after start of the intervention ] Other Outcome Measures: Frequency of falls [ Time Frame: Daily for 5 weeks ] Frequency of headaches [ Time Frame: 5 weeks ]Frequency of headaches will be assessed using the headache disability index Eligibility CriteriaGo to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Layout table for eligibility information Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: 2b1af7f3a8