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PoNS Clinical Experience Program in Traumatic Brain Injury Patients (TBI) | Clinical Trials | Clareo Health

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PoNS Clinical Experience Program in Traumatic Brain Injury Patients (TBI)

An Open-label Study of Safety and Effectiveness of the Portable Neuromodulation Stimulator (PoNS®) Treatment for Subjects with a Chronic Balance Deficit Due to Mild-to-moderate Traumatic Brain Injury (TBI)

NCT03881176•Helius Medical Inc

View on ClinicalTrials.gov

Summary

\- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical exercises and repeated use of the PoNS device. Subjects who meet the initial screening entrance criteria will be scheduled for a baseline assessment to evaluate balance and gait. Subjects will then begin the PoNS Treatment program and re-perform some assessments at 2, 5 and 14 weeks evaluating their functional improvements.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Criteria for Inclusion/Exclusion:
•Subjects must present with a chronic balance deficit due to mild-to-moderate TBI. However, other potentially related symptoms, such as gait disturbance, mild to moderate recurrent headaches, sleep, memory, attention, and cognitive deficits, will be noted on the data collection form at screening and each subsequent evaluation.
•1. At least 18 years of age, inclusive, at the time of screening.
•2. Acceptable results (as determined by the investigator) of a full history and physical performed or supervised by the investigator at each site. This will include a careful examination of the tongue and oral cavity for any abnormalities. History should include the nature and duration of any prior physical therapy program the subject may have participated in to address the balance and/or gait symptoms of their TBI. Prior participation in therapy is not a prerequisite for enrollment in the program
•3. Documentation on the history of a qualifying TBI, mild to moderate in severity. For reference, the Armed Forces Health Surveillance Branch (AFHSB) definitions of mild and moderate TBI will be used. The definitions are as follows:
•* Mild TBI: Confused or disoriented state which lasts less than 24 hours; or loss of consciousness for up to 30 minutes, or memory loss lasting less than 24 hours. Excludes penetrating TBI.
•* Moderate TBI: Confused or disoriented state which lasts more than 24 hours; and/or loss of consciousness for more than 30 minutes but less than 24 hours, or memory loss lasting greater than 24 hours but less than seven days; or meets criteria for Mild TBI except an abnormal CT scan is present. Excludes penetrating TBI.
•The investigator will ascertain whether the prior medical records and information collected during the clinical interview are sufficiently detailed to support the classification of the TBI.
•4. Acceptable results from within the last three (3) months as determined by the site investigator of basic standard blood work to include CBC, TSH, HbA1C, Liver and Kidney panels, and a 12-lead ECG with automated reporting capability. Any abnormal result that is judged clinically significant by the investigator will be communicated to the subject and if treated by their personal physician and deemed recovered, the subjects may be reconsidered for inclusion. If the investigator is uncertain he or she will communicate with the Sponsor's Medical Officer.
•5. If female, the subject is not pregnant, not breastfeeding and has a negative pregnancy test prior to receipt of the PoNS device
+10 more criteria

Exclusion Criteria

•1. Medical findings from screening history, physical examination or radiological test that the investigator deems clinically significant or that would otherwise impact patient safety or data integrity.
•2. Planned use or use of any investigational product (i.e., not approved by the FDA), pharmaceutical or device, within 30 days preceding receipt of the PoNS device and during the entire period of subject participation.
•3. Any previous use of the Portable Neuromodulation Stimulator (PoNS)
•4. Balance or gait deficits due to lower extremity injury or neurological condition other than TBI.
•5. Severe TBI defined as an injury with a confused or disoriented state which lasts more than 24 hours; and/or loss of consciousness for more than 24 hours, or memory loss for more than seven days.
•6. Penetrating brain injury, refractory subdural hematoma, or craniotomy unrelated to the resolution of qualifying traumatic brain injury. Investigator discretion may be exercised on an individual case where surgery was performed that did not remove or significantly alter brain tissue (e.g., to treat a brain aneurysm). Surgery must have been performed at least 6 months prior to screening and a CT scan must be provided to demonstrate no large residual lesions.
•7. Oral health problems active at the time of recruitment. Any history of oral health problems (e.g., gum disease or cankers) will be noted on the data collection form.
•8. Oral surgery within 3 months of screening.
•9. History of oral cancer.
•10. Non-removable metal orthodontic devices (e.g., braces) or oral cavity piercings that could interfere with PoNS use.
+21 more criteria

Locations (1)

North Shore University Hospital

Manhasset, New York, United States

Key Dates

Start Date

September 21, 2018

Primary Completion Date

November 30, 2019

Completion Date

November 30, 2019

Last Updated

March 28, 2025

Enrollment

ACTUAL participants

Conditions

Mild to Moderate Traumatic Brain Injury

Interventions

PoNS Treatment

DEVICE