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Noninvasive Neuromodulation for Treatment of Symptoms Due to Mild or Moderate Traumatic Brain Injury

NCT02158494 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-05-03

Study results available
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Summary

The investigators hypothesis is that electrical stimulation to the tongue that directly stimulates two cranial nerve nuclei (Trigeminal and Facial Nerve Nuclei), will excite neural impulses to the brainstem and cerebellum. The investigators call this cranial nerve non-invasive neuromodulation (CN-NINM). The activation of these structures induces neuroplasticity when combined with specific physical, cognitive and/or mental exercises, promoting recovery of selected functional damage such as problems with balance or walking.

44 subjects will be recruited for 2 weeks of intensive In-Lab Balance and Gait Training followed by 12 weeks of intensive Home Training with weekly In-Lab check sessions. Half of the subjects will use CN-NINM in conjunction with the exercise. Half of the subjects will use very low level stimulation in conjunction with the exercise, and will serve as a control group.

Conditions

  • Brain Injuries, Traumatic

Interventions

DEVICE

Balance and Gait Training using neurostimulation modulation.

CN-NINM uses sequenced patterns of electrical stimulation on the tongue. Our hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.

DEVICE

Sham Device

The sham device is visually identical to the CN-NINM device, and offers a non-zero, minimally perceivable stimulation.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Mitchell E Tyler, MS · TCNL, Department of Kinesiology, University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-05-31
Completion
2017-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02158494 on ClinicalTrials.gov