PoNS Clinical Experience Program (TBI)

NCT03852732 | Unknown DMC FDA Device

• 1 other identifier: NHC-TBI-PoNS-CE BAYLOR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild to Moderate Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Mean change in balance score (SOT) from baseline to the end of 14 weeks

  Baseline, 2 weeks, 5 weeks and 14 weeks

Study Arms (1)

Active

EXPERIMENTAL

PoNS Treatment will consist of three stages: an in-clinic training program, a home training program, and an extended home training program. During all stages of the study, subjects will complete three training sessions per day, morning, afternoon and evening, 6 days per week.

Device: PoNS Treatment

Interventions

PoNS Treatment DEVICE

PoNS Treatment will consist of three stages: an in-clinic training program, a home training program, and an extended home training program. During all stages of the study, subjects will complete three training sessions per day, morning, afternoon and evening, 6 days per week. Daily Training Program: The same daily training program will be performed during all stages with the exception of the morning BAT session, which is not performed during stage 2 or 3: Morning: Warm Up Exercises without the PoNS Balance Training with PoNS Gait Training with PoNS Breathing and Awareness Training (BAT) with PoNS 3- to 4-hour break between morning and afternoon sessions Afternoon: Balance Training with PoNS Movement Control Training without PoNS Gait Training with PoNS Evening: Breathing and Awareness Training with PoNS To be performed at home during all stages

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• At least 18 years of age, inclusive, at the time of screening.
• 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
• 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.
• If female, the subject is not pregnant, not breastfeeding and has a negative pregnancy test prior to receipt of the PoNS device
• \- Note: Pregnancy testing will be repeated at end-of-study (EOS) (i.e., end of at home period).
• If female is of childbearing potential, the subject agrees to use adequate contraception from screening and throughout the study period.
• A female of non-childbearing potential is defined as a subject who is postmenopausal (continuous amenorrhea for 12 months) or surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
• Balance disorder as indicated by the NeuroCom® Sensory Organization Test (SOT) composite score at least 16 points below normal \[adjusted for age and height, based on normative data\] due to a mild-to-moderate traumatic brain injury (TBI).
• At least three (3) months post most recent TBI at the time of screening.
• Stable neurologic status, as determined from subject's medical records and the study physician's opinion based on no new or changing symptoms.
• Qualifying MRI report to be entered into the data collection form. For all participants who do not have a qualifying MRI, a new MRI will be obtained.

Sponsors & Collaborators

• Helius Medical Inc: lead
• Baylor Institute for Rehabilitation: collaborator

Study Sites (1)

Baylor Scott & White Institute for Rehabilitation

Dallas, Texas, 75246, United States

RECRUITING

Central Study Contacts

Dianna Robinson

CONTACT

214-818-8688; Dianna.Robinson@BSWHealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 25, 2019
• Study Start: February 21, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)