The Use of the PoNS™ Device in the Treatment of Blunt and Blast Induced Vestibular Disorders

NCT01771575 | Withdrawn

• 1 other identifier: NMCSD.2013.0011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Traumatic brain injury (TBI) is a major worldwide health issue. Figures from the Centers for Disease control show that 1.7 million people suffer a TBI annually. Meanwhile the World Health Organization recognizes TBI as one of the most significant health issues in developing countries. In the military, mild traumatic brain injury (mTBI) is one of the most frequent sequela of modern war. Dizziness and balance disorders are the most frequent sequela of mTBI and account for a significant degree of mTBI morbidity. At the current time, the best treatment modality for dizziness secondary to mTBI is vestibular rehabilitation (VR). While VR is effective, the therapy is time consuming, not universally successful, and results in incomplete recovery by many patients. Work needs to be done in an attempt to improve therapy outcomes. This project will study the use of neuromodulation (through stimulation of the tongue) as an adjuvant to improve the effectiveness of VR and reduce the time involved in VR. Given past work with variants on this minimal medical impact appliance, using the PoNS™ device to augment therapy may result in a significant improvement in VR outcomes. Given the enormous public health and military burden of mTBI, and given that dizziness is a major component often responsible for significant morbidity, this project has significant military and civilian impact and can be beneficial to those who suffer mTBI worldwide.

Conditions

Hearing and Vestibular Disorders

Outcome Measures

Primary Outcomes (1)

• Change in Sensory Organization Test score

  Posturography for Sensory Organization Test: Utilizing a computerized dynamic posturography (Neurocom Inc., Clackmas, OR) the sensory organization test (SOT) is conducted by measuring postural sway on a force plate under six different conditions as follows 1) Normal Stance eyes open, 2) Normal Stance with eyes closed, 3) Normal Stance with sway referenced visual surround, 4) Sway reference stance eyes open, 5) Sway reference stance with eyes closed, and 6) Sway reference stance with sway referenced vision. The SOT will conduct three trials in each condition and utilize the information to produce a computer generated objective score of balance/posture function. The exam takes less than ten minutes to produce.

  Change from Baseline SOT score at 3 months

Secondary Outcomes (1)

• Change in Vestibular-Ocular Reflex scores

  Change from Baseline VOR score at 3 months

Other Outcomes (3)

• Change in Functional Gait Assessment Test scores

  Change from Baseline FGAT score at 3 months

• Change in Dizziness Handicap Index scores

  Change from Baseline DHI score at 3 months

• Change in Activities specific Balance Confidence scale scores

  Change from Baseline ABC score at 3 months

Study Arms (2)

Treatment Arm

EXPERIMENTAL

PoNS™ device

Device: PoNS™ device

Placebo Arm

PLACEBO COMPARATOR

placebo device

Other: Placebo device

Interventions

Placebo device OTHER

Placebo device

Placebo Arm

PoNS™ device DEVICE

The PoNS™ device uses electrotactile waveform in conjunction with the Cranial Nerve - Non-Invasive NeuroModulation (CN-NINM) intervention. This involves using both balance and gait training methods to stabilize symptoms, regain balance \& gait, and affect the functional transfer of improved stability and mobility to activities of daily living. It is based on a body of work focused on developing the tongue-based human-machine interface and application of this technology for balance, vision, and auditory substitution and more recently as neuromodulation for brain rehabilitation after injury and disease.

Also known as: Portable Neuromodulation Stimulator, version 2.2

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Head Injury from blunt or blast suffered within the lines of duty

You may not qualify if:

• Injury occurred 21 -365 days ago
• History of a diagnosed balance disorder prior to injury
• Going through board process before starting participation
• Significant medical issues including but not limited to heart disease, pulmonary disease, autoimmune disorders, severe arthritis, etc.
• Orthopedic injuries that prevent standing and walking
• Age less than 18 or greater than 40 years of age

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead
• The Geneva Foundation: collaborator

Study Sites (1)

Naval Medical Center, San Diego

San Diego, California, 92134, United States

Location

Study Officials

• Michael E. Hoffer, M.D.

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Administrator

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 18, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)