Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02429167 · ClinicalTrials.gov registry record · NA
Study of Safety and Effectiveness of PoNS Device to Treat Chronic Balance Deficit Due to Traumatic Brain Injury (TBI)
A NA study, sponsored by Helius Medical.
- Completed
- Registry status
- NA
- Development phase
- 122
- Enrollment target
NCT02429167: Completed NA study, sponsored by Helius Medical.
NCT02429167 is a NA study that has completed, run by Helius Medical. The registered enrollment target is 122 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02429167, a NA study, has completed, sponsored by Helius Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 122 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if clinic and home training with a study device will improve a balance deficit. The study device is called Portable Neuromodulation Stimulator (PoNS). The study device will be placed on the tongue to deliver nerve stimulation. The study is testing if use of the study device in conjunction with physical therapy will improve balance and gait in patients suffering from a TBI. The effects of using the device and undergoing therapy will be measured using standardized tests of movement control, gait, headache and other TBI symptoms.
Primary Outcome
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.
Interventions
- DEVICE Cranial nerve non-invasive neuromodulation via PoNS device
- DEVICE Sham PoNS device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2015-08 |
| Est. Completion | 2017-08-18 |
| Phase | NA |
What the finished NCT02429167 record still lists
NCT02429167 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Cranial nerve non-invasive neuromodulation via PoNS device is the first listed.
NCT02429167 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02429167 about?
NCT02429167 is a clinical study titled "Study of Safety and Effectiveness of PoNS Device to Treat Chronic Balance Deficit Due to Traumatic Brain Injury (TBI)". The purpose of this study is to determine if clinic and home training with a study device will improve a balance deficit. The study device is called Portable Neuromodulation Stimulator (PoNS). The study device will be placed on the tongue to deliver nerve stimulation. The study is testing if use of ...
What is the current status of trial NCT02429167?
This trial is currently completed. It is a NA study. The enrollment target is 122 participants. The study started on 2015-08. Estimated completion is 2017-08-18.
What interventions are being tested in trial NCT02429167?
The interventions under investigation include: Cranial nerve non-invasive neuromodulation via PoNS device (DEVICE), Sham PoNS device (DEVICE).
Who is sponsoring clinical trial NCT02429167?
This trial is sponsored by Helius Medical, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02429167's enrollment target sits among peer trials
122 762nd of 2000 higher than 1,239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03363373 · 122 participants · Phase 2
Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
- NCT03463954 · 122 participants · NA
Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors
- NCT04503265 · 122 participants · Phase 1
A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
- NCT04700527 · 122 participants · Phase 1
The Effects of SCFA Supplementation in Subjects Receiving Abdominopelvic RT: A Randomized Controlled Study
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia