OBJECTIVE: To systematically review the medical literature and comprehensively summarize clinical research done on rehabilitation with a novel portable and non-invasive electrical stimulation device, called the cranial nerve noninvasive neuromodulator (CN-NINM) in patients suffering from nervous system disorders. The CN-NINM induces processes of neuroplasticity by noninvasive stimulation of four cranial nerves and targets the subcortical area of the brain. DATA SOURCES: PubMed, Medline and the Cochrane Database from 1966 to March 2013. STUDY SELECTION: Studies were included if they recruited adult patients with peripheral and central nervous system disorders and were treated with CN-NINM and were assessed with objective measures of function. DATA EXTRACTION: After title and abstract screening of potential articles, full texts were independently reviewed to identify articles that met inclusion criteria. DATA SYNTHESIS: The search identified twelve publications, five were critically reviewed and two combined in a meta-analysis. There were no randomized controlled studies identified and the meta-analysis was based on pre-post studies. Most of the patients were individuals with a chronic balance dysfunction. The pooled results demonstrated significant improvements in (1) Dynamic Gait Index (DGI) post-intervention with a mean difference 3.45 (1.75 to 5.15; p < 0.001); (2) the ABC scale with a mean difference of 16.65 (7.65 to 25.47; p < 0.001); and (3) the DHI with improvements of -26.07 (-35.78 to -16.35; p < 0.001). Included studies suffered from small sample sizes, lack of randomization, absence of blinding, use of referral populations, and variability in treatment schedules and follow-up rates. CONCLUSIONS: Given these limitations, the results of the meta-analysis must be interpreted cautiously. Further investigation using rigorous randomized clinical controlled trials are needed to evaluate this promising rehabilitation tool for nervous system disorders.

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