CompletedNot Applicable

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

United States44 participantsStarted 2014-05

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All candidates will have a balance disorder as a result of a traumatic brain injury (TBI). * All candidates will have a NeuroCom® Sensory Organization Test (SOT) composite score at least 8 points below normal after adjustment for age and height \[based on normative data\]. * All candidates will be between the ages of 18 and 65 (at the time of screening). * If female of childbearing potential, the candidate agrees to use adequate contraception throughout participation in the study (from enrollment to completion). * All candidates must have access to a treadmill. * All candidates will be at least 1 year post-injury. * All candidates will have a neuroradiologic scan and report after their most recent TBI. * All candidates will be ambulatory and able to walk for 20 minutes. * All candidates, if on medications, will not have had any major changes in type or dosage within 3 months of enrollment. * All candidates will have participated in a focused physical rehabilitation program for their TBI and feel that they have reached a plateau. * All candidates will be able to understand and willing to give informed consent. Exclusion Criteria: * All candidates that have oral health problems (e.g. gum disease, active cankers, piercings, oral surgery within the previous 3 months). * All candidates with non-removable metal orthodontic devices (e.g., braces) or oral cavity piercings that could interfere with PoNS™ use. * All candidates who have chronic infectious diseas…

What they're measuring

NeuroCom Computerized Dynamic Posturography Sensory Organization Test (SOT)

Timeframe: Baseline, 2, 14, and 26 weeks

Trial details

NCT IDNCT02158494

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-05

Results submitted2019-01-08