Tinnitus is a phantom auditory perception coded in the brain that can be bothersome or debilitating, affecting 10 to 15% of the population. Currently, there is no clinically recommended drug or device treatment for this major health condition. Animal research has revealed that sound paired with electrical somatosensory stimulation can drive extensive plasticity within the brain for tinnitus treatment. To investigate this bimodal neuromodulation approach in humans, we evaluated a noninvasive device that delivers sound to the ears and electrical stimulation to the tongue in a randomized, double-blinded, exploratory study that enrolled 326 adults with chronic subjective tinnitus. Participants were randomized into three parallel arms with different stimulation settings. Clinical outcomes were evaluated over a 12-week treatment period and a 12-month posttreatment phase. For the primary endpoints, participants achieved a statistically significant reduction in tinnitus symptom severity at the end of treatment based on two commonly used outcome measures, Tinnitus Handicap Inventory (Cohen’s d effect size: −0.87 to −0.92 across arms; P < 0.001) and Tinnitus Functional Index (−0.77 to −0.87; P < 0.001). Therapeutic improvements continued for 12 months after treatment for specific bimodal stimulation settings, which had not previously been demonstrated in a large cohort for a tinnitus intervention. The treatment also achieved high compliance and satisfaction rates with no treatment-related serious adverse events. These positive therapeutic and long-term results motivate further clinical trials toward establishing bimodal neuromodulation as a clinically recommended device treatment for tinnitus.
Objective: To examine the association between eating in response to hunger and satiety signals (intuitive eating) and BMI. A second objective was to determine whether the hypothesized higher BMI in less intuitive eaters could be explained by the intake of specific foods, speed of eating or binge eating. Design: Cross-sectional survey. Participants were randomly selected from a nationally representative sampling frame. Eating in response to hunger and satiety signals (termed 'intuitive eating'), self-reported height and weight, frequency of binge eating, speed of eating and usual intakes of fruits, vegetables and selected high-fat and/or high-sugar foods were measured. Setting: Nationwide study, New Zealand. Subjects: Women (n 2500) aged 40-50 years randomly selected from New Zealand electoral rolls, including Māori rolls (66 % response rate; n 1601). Results: Intuitive Eating Scale (IES) scores were significantly associated with BMI in an inverse direction, after adjusting for potential confounding variables. When controlling for confounding variables, as well as potential mediators, the inverse association between intuitive eating (potential range of IES score: 21-105) and BMI was only slightly attenuated and remained statistically significant (5?1 % decrease in BMI for every 10-unit increase in intuitive eating; 95 % CI 4?2, 6?1 %; P , 0?0 0 1). The relationship between intuitive eating and BMI was partially mediated by frequency of binge eating. Conclusions: Eating in response to hunger and satiety signals is strongly associated with lower BMI in mid-age women. The direction of causality needs to be investigated in longitudinal studies and randomized controlled trials.
The posterior cingulate cortex (PCC) is involved in food craving in obese food addicted individuals. This randomised, double-blind, placebo-controlled parallel study explored the potential therapeutic effects of infraslow neurofeedback (ISF-NF) on food craving targeting the PCC in obese women with symptoms of food addiction. Participants received six sessions of either ISF-NF (n = 11) or placebo (n = 10) over a three-week period. There were no reported adverse effects. Electrophysiologically, there were significant increases in infraslow activity (p = 0.0002) and infraslow/beta nesting (p < 0.001) in the PCC in the ISF-NF group (mean r = 0.004 ± 0.002) compared to placebo (mean r = 0.02 ± 0.002) two days after the last intervention. Also, there was a significant decrease in different dimensions of state food craving compared to baseline and to placebo. Findings suggest that source localized IFS-NF results in electrophysiological changes and may be associated with reduced food craving. This trial is registered at www.anzctr.org.au, identifier, ACTRN12617000601336. This study was funded by the Otago Medical Research Grant: CT375.
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