Effects of Repetitive Peripheral Sensory Stimulation in the Subacute and Chronic Phases After Stroke: Study Protocol for a Pilot Randomized Trial.

BACKGROUND: Repetitive peripheral nerve sensory stimulation (RPSS) is a potential add-on intervention to motor training for rehabilitation of upper limb paresis after stroke. Benefits of RPSS were reported in subjects in the chronic phase after stroke, but there is limited information about the effects of this intervention within the 1st weeks or months. The primary goal of this study is to compare, in a head-to-head proof-of-principle study, the impact of a single session of suprasensory vs. subsensory RPSS on the upper limb motor performance and learning in subjects at different phases after stroke subacute and chronic phases and mild upper limb motor impairments after stroke. In addition, we examine the effects of RPSS on brain perfusion, functional imaging activation, and γ-aminobutyric acid (GABA) levels. Subjects with mild upper limb motor impairments will be tested with MRI and clinical assessment either at an early (7 days to 3 months post-stroke) or at a chronic (>6 months) stage after stroke. METHODS: In this multicenter, randomized, parallel-group, proof-of-principle clinical trial with blinded assessment of outcomes, we compare the effects of one session of suprasensory or subsensory RPSS in patients with ischemic or hemorrhagic stroke and upper limb paresis. Clinical assessment and MRI will be performed only once in each subject (either at an early or at a chronic stage). The primary outcome is the change in performance in the Jebsen-Taylor test. Secondary outcomes: hand strength, cerebral blood flow assessed with arterial spin labeling, changes in the blood oxygenation level-dependent (BOLD) effect in ipsilesional and contralesional primary motor cortex (M1) on the left and the right hemispheres assessed with functional MRI (fMRI) during a finger-tapping task performed with the paretic hand, and changes in GABA levels in ipsilesional and contralesional M1 evaluated with spectroscopy. The changes in outcomes will be compared in four groups: suprasensory, early; subsensory, early; suprasensory, chronic; and subsensory, chronic. DISCUSSION: The results of this study are relevant to inform future clinical trials to tailor RPSS to patients more likely to benefit from this intervention. TRIAL REGISTRATION: NCT03956407.

Pituitary volume and the effects of phototherapy in patients with seasonal winter depression: a controlled study.

OBJECTIVES: Our aims were to investigate the pituitary volume in patients with seasonal winter depression and healthy volunteers in winter and summer, and to assess the effects of phototherapy in these patients. METHOD: The pituitary volume of 12 patients with winter depression and 12 healthy controls, paired according gender, age and menstrual cycle, were obtained from magnetic resonance imaging in winter and summer. Eight patients were submitted to phototherapy (10000 vs. 2500 lux) in a double-blind crossover fashion during the winter, and reassessed (symptoms and magnetic resonance imaging) after treatment. RESULTS: There were no significant differences in pituitary volume between controls and patients in winter or summer. Exposure to phototherapy (10000 lux) decreased the depressive symptoms (p = 0.004), but the glandular volume did not change (p = 0.5). However, the pituitary volume in winter showed a positive correlation with the severity of depression in these patients (r = 0.69, p = 0.04). CONCLUSIONS: The results suggest that neither winter depression nor the change of seasons is associated with significant change in the pituitary volume. Despite the fact that this study was performed in a tropical area, phototherapy with 10000 lux showed to be an efficient treatment in this SAD patients sample.

Pituitary volume and the effects of phototherapy in patients with seasonal winter depression: a controlled study

OBJECTIVES: Our aims were to investigate the pituitary volume in patients with seasonal winter depression and healthy volunteers in winter and summer, and to assess the effects of phototherapy in these patients. METHOD: The pituitary volume of 12 patients with winter depression and 12 healthy controls, paired according gender, age and menstrual cycle, were obtained from magnetic resonance imaging in winter and summer. Eight patients were submitted to phototherapy (10000 vs. 2500 lux) in a double-blind crossover fashion during the winter, and reassessed (symptoms and magnetic resonance imaging) after treatment. RESULTS: There were no significant differences in pituitary volume between controls and patients in winter or summer. Exposure to phototherapy (10000 lux) decreased the depressive symptoms (p = 0.004), but the glandular volume did not change (p = 0.5). However, the pituitary volume in winter showed a positive correlation with the severity of depression in these patients (r = 0.69, p = 0.04). CONCLUSIONS: The results suggest that neither winter depression nor the change of seasons is associated with significant change in the pituitary volume. Despite the fact that this study was performed in a tropical area, phototherapy with 10000 lux showed to be an efficient treatment in this SAD patients sample.

OBJETIVOS: Nossos objetivos foram investigar o volume da pituitária em pacientes com depressão sazonal de inverno e controles sadios, no inverno e verão, e avaliar os efeitos da fototerapia nesses pacientes. MÉTODO: O volume da pituitária de 12 pacientes com depressão de inverno e 12 controles sadios, pareados quanto ao gênero, idade e fase do ciclo menstrual, foi examinado por meio de imagem por ressonância magnética no inverno e verão. Oito pacientes foram submetidos à fototerapia (10.000 vs 2.500 lux) de forma duplo-cega e cruzada durante o inverno e reavaliados (sintomas e imagem por ressonância magnética) após o tratamento. RESULTADOS: Não houve diferença significativa no volume da pituitária entre controles e pacientes, no inverno e verão. A fototerapia (10.000 lux) reduziu os sintomas depressivos (p = 0,004), mas não alterou o volume glandular (p = 0,5). Contudo, o volume da pituitária, no inverno, mostrou uma correlação positiva com a gravidade da depressão nesses pacientes (r = 0,69, p = 0,04). CONCLUSÕES: Os resultados sugerem que nem a depressão de inverno, nem a mudança das estações estão associadas com a mudança significativa do volume da pituitária. Apesar do fato deste estudo ter sido realizado em uma região tropical, a fototerapia com 10.000 lux mostrou-se um tratamento eficaz nesta amostra.