scholarly journals Percutaneous mastoid electrical stimulator improves Poststroke depression and cognitive function in patients with Ischaemic stroke: a prospective, randomized, double-blind, and sham-controlled study

BMC Neurology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Taoli Lu ◽  
Lanying He ◽  
Bei Zhang ◽  
Jian Wang ◽  
Lili Zhang ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Ischaemic Stroke ◽  
Controlled Study ◽  
Poststroke Depression ◽  
Double Blind ◽  
Electrical Stimulator

scholarly journals Percutaneous Mastoid Electrical Stimulator Improves Poststroke Depression and Cognitive F unction in Patients with Ischaemic Stroke: A Prospective, Randomized, Double-blind, and Sham-controlled Study

2020 ◽  
Author(s):  
Taoli Lu ◽  
Lanying He ◽  
Bei Zhang ◽  
Jian Wang ◽  
Lili Zhang ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Sham Group ◽  
Mean Value ◽  
Controlled Study ◽  
Poststroke Depression ◽  
Score Change ◽  
Double Blind ◽  
The Mean ◽  
Electrical Stimulator ◽  
Moca Score

Abstract Background : Poststroke depression can lead to functional dependence, cognitive impairment and reduced quality of life. The aim of this study was to evaluate the effects of a percutaneous mastoid electrical stimulator (PMES) plus antidepressants on poststroke depression and cognitive function. Methods: This study was a prospective, randomized, double-blind, and sham-controlled study . A total of 258 clinically depressed ischaemic stroke patients within 14 days of index stroke were randomly assigned to the PMES plus antidepressant (PMES group, N=125) and sham plus antidepressant (sham group, N=133) groups. All patients underwent the Montreal Cognitive Assessment (MoCA) and Hamilton Rating Scale for Depression (HRSD) test at 2 weeks (baseline), and 6 months(M6) after ischaemic stroke. Primary outcomes were the percentage of patients showing a treatment response (≥50% reduction in HRSD score) and depression remission (HRSD score≤9) at 6 months. The secondary outcome was the percentage of patients with a MoCA score <26 . Results: The percentages of patients showing a treatment response and depression remission were significantly higher in the PMES group than in the sham group (57.60% vs 41.35%, P=0.009; 44.00% vs 29.32%, P=0.014 respectively). The mean value of the HRSD score change [M(month)6-baseline] was significantly higher in the PMES group than in the sham group at 6 months (-11.93 ±5.32 vs -10.48 ± 6.10, P = 0.036, respectively). The percentage of patients with MoCA scores <26 was lower in the PEMS group than in the sham group(12.0% vs 24.06%, P=0.012,respectively), and the mean value of the MoCA score change (M6-baseline) was higher in the PMES group than in the sham group (3.50±2.55 vs 2.72±2.52, P=0.005,respectively). Conclusion: These findings demonstrate that PMES adjunctive to antidepressant therapy is effective in reducing depression, achieving remission in the short term, and improving cognition. Trial registration: This trial was retrospectively registered (registration number: ChiCTR1800016463) on 03 June 2018

scholarly journals Percutaneous Mastoid Electrical Stimulator improves poststroke depression and cognitive function in patients with ischemic stroke:A Prospective, Randomized, Double-blind, and Sham-controlled Study

2020 ◽  
Author(s):  
Taoli Lu ◽  
lanying he ◽  
Bei Zhang ◽  
Jian Wang ◽  
Lili Zhang ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Sham Group ◽  
Mean Value ◽  
Controlled Study ◽  
Poststroke Depression ◽  
Score Change ◽  
Double Blind ◽  
The Mean ◽  
Electrical Stimulator ◽  
Moca Score

Abstract Backgrond : Poststroke depression could lead to functional dependence, cognitive impairment and reduced quality of life. The aim of this study was to evaluate the effects of percutaneous mastoid electrical stimulator (PMES) plus antidepressant on poststroke depression and cognitive function. Methods: This study was a prospective, randomized, double-blind, and sham-controlled study . 258 clinically depressed ischemic stroke patients within 14 d of index stroke were randomly assigned to PMES plus antidepressant (PMES group, N=125) and sham plus antidepressant (sham group, N=133). All patients underwent Montreal Cognitive Assessment (MoCA) and Hamilton Rating Scale for Depression (HRSD) test at 2 weeks (baseline), and 6 months after the stroke. Primary outcomes were the percentage of treatment response (≥50% reduction in HRSD score) and depression remission (HRSD score≤9) at 6 months. Secondary outcome was the percentage of MoCA score <26. Results: The percentage of treatment response and depression remission in PMES group were significantly higher than that in the sham group (57.60% vs 41.35%, P=0.009), (44.00% vs 29.32%, P=0.014), respectively. The mean value of HRSD score change(M6-baseline) was significantly greater in the PMES group compared to sham group at 6 months (-11.93 ±5.32 vs -10.48 ± 6.10, P = 0.036). The percentage MoCA score <26 in PEMS group was lower than that in sham group(12.0% vs 24.06%, P=0.012), the mean value of MoCA score change (M6-baseline) was higher in PMES group compared to sham group (3.50±2.55 vs 2.72±2.52; P=0.005). Conclusion: These findings demonstrate that PMES adjunctive to antidepressant therapy is effective in reducing depression, achieving remission in the short term, and improving cognition. Trial registration: This trial was retrospectively registered (registration number: ChiCTR1800016463) on 03 June 2018

scholarly journals Percutaneous Mastoid Electrical Stimulator improves poststroke depression and cognitive function in patients with ischemic stroke:A Prospective, Randomized, Double-blind, and Sham-controlled Study

2020 ◽  
Author(s):  
Taoli Lu ◽  
Lanying He ◽  
Bei Zhang ◽  
Jian Wang ◽  
Lili Zhang ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Sham Group ◽  
Mean Value ◽  
Controlled Study ◽  
Poststroke Depression ◽  
Score Change ◽  
Double Blind ◽  
The Mean ◽  
Electrical Stimulator ◽  
Moca Score

Abstract Backgrond: Poststroke depression could lead to functional dependence, cognitive impairment and reduced quality of life. The aim of this study was to evaluate the effects of percutaneous mastoid electrical stimulator (PMES) plus antidepressant on poststroke depression and cognitive function. Methods: This study was a prospective, randomized, double-blind, and sham-controlled study. 258 clinically depressed ischemic stroke patients within 14 d of index stroke were randomly assigned to PMES plus antidepressant (PMES group, N=125) and sham plus antidepressant (sham group, N=133). All patients underwent Montreal Cognitive Assessment (MoCA) and Hamilton Rating Scale for Depression (HRSD) test at 2 weeks (baseline), and 6 months after the stroke. Primary outcomes were the percentage of treatment response (≥50% reduction in HRSD score) and depression remission (HRSD score≤9) at 6 months. Secondary outcome was the percentage of MoCA score <26. Results: The percentage of treatment response and depression remission in PMES group were significantly higher than that in the sham group (57.60% vs 41.35%, P=0.009), (44.00% vs 29.32%, P=0.014), respectively. The mean value of HRSD score change(M6-baseline) was significantly greater in the PMES group compared to sham group at 6 months (-11.93 ±5.32 vs -10.48 ± 6.10, P = 0.036). The percentage MoCA score <26 in PEMS group was lower than that in sham group(12.0% vs 24.06%, P=0.012), the mean value of MoCA score change (M6-baseline) was higher in PMES group compared to sham group (3.50±2.55 vs 2.72±2.52; P=0.005). Conclusion: These findings demonstrate that PMES adjunctive to antidepressant therapy is effective in reducing depression, achieving remission in the short term, and improving cognition. Trial registration: This trial was retrospectively registered (registration number: ChiCTR1800016463) on 03 June 2018

scholarly journals Antiplatelet effects of citalopram in patients with ischaemic stroke: A randomized, placebo-controlled, double-blind study

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Kristian Lundsgaard Kraglund ◽  
Janne Kaergaard Mortensen ◽  
Søren Paaske Johnsen ◽  
Grethe Andersen ◽  
Erik Lerkevang Grove
Keyword(s):  
Platelet Aggregation ◽  
Ischaemic Stroke ◽  
Acute Ischaemic Stroke ◽  
Platelet Reactivity ◽  
Significant Inhibition ◽  
Controlled Study ◽  
Double Blind Study ◽  
Stroke Patients ◽  
Double Blind ◽  
Ssri Treatment

AbstractWe evaluated the effect of SSRI treatment on platelet aggregation in patients with ischaemic stroke and included patients from the randomized double-blind controlled study of citalopram in acute ischaemic stroke (TALOS). Patients on clopidogrel were included 6 months after acute ischaemic stroke. Platelet parameters, including P2Y12 platelet reactivity using the VerifyNow System, were measured at the last day of study treatment and repeated after a 14-day wash-out period. A total of 60 patients were included (n = 32 randomized to citalopram). Platelet aggregation levels did not differ between the citalopram group (mean 116, 95% CI 89 to 143) and the placebo group (mean 136, 95% CI 109 to 163) (On-treatment, p = 0.14). Similarly, there was no significant change in platelet aggregation in the citalopram group from on-treatment to post-treatment (mean difference 2.0; 95% CI −18 to 14). Platelet count, size and turnover were not affected by SSRI treatment. In conclusion, SSRI therapy did not lead to statistically significant inhibition of platelet aggregation in ischaemic stroke patients treated with clopidogrel.

Phase II double-blind placebo-controlled study of armodafinil for brain radiation induced fatigue.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9505-9505 ◽  
Author(s):  
Edward G. Shaw ◽  
Doug Case ◽  
David Bryant ◽  
David Grisell ◽  
Glenn Lesser ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Phase Ii ◽  
Concurrent Chemotherapy ◽  
Phase Iii ◽  
Controlled Study ◽  
Low Grade ◽  
Eligibility Criteria ◽  
Double Blind ◽  
Phase Iii Study ◽  
Brain Radiation

9505 Background: Armodafinil (ARM), the R-enantiomer of modafinil, is FDA approved for narcolepsy, shift work disorder, and treated sleep-apnea, and has also been shown to reduce fatigue/improve cognitive function in cancer patients. This phase II study estimated the efficacy and toxicity of ARM in primary brain tumor (PBT) patients receiving brain radiation therapy (RT) to determine whether a larger phase III study would be warranted. Methods: Eligibility criteria – adult, PBT, total RT dose >45Gy, KPS>60, no severe headaches, and concurrent chemotherapy allowed. Patients were assessed at baseline, end of RT, then 4 weeks after end RT with the Brief Fatigue Inventory (BFI), Epworth Sleep Scale (ESS), FACT, and FACT brain and FACIT fatigue subscales. Patients were randomized to receive ARM 150mg/day during RT and for 4 weeks after RT or placebo (PLAC). Results: 54 patients enrolled between 9/10-12/12; 26 to ARM, 28 to placebo PLAC. Median age 59; 59% female; 95% White; 41% KPS 90-100, 59% KPS 60-80; 74% malignant glioma, 26% low-grade glioma/benign histology. 83% patients had concurrent chemotherapy. For all randomized patients, there were no statistically significant differences in outcome between ARM and PLAC groups at end-RT vs. baseline or 4 weeks post RT vs. baseline. For patients who had more baseline fatigue (fatigue subscale score <median), ARM-treated patients had significantly/suggestively better outcomes at end-RT vs. baseline compared to PLAC-treated patients: less fatigue (BFI p=0.056, fatigue subscale p=0.0295), less sleepiness (ESS p=0.1034), and better QOL (FACT p=0.0001). Incidence of grade 2/3 toxicities was the same between the two treatment groups: 7% anxiety, 7% nausea, 18% headaches, and 20% insomnia. There were no grade 4 or 5 toxicities. Conclusions: In irradiated PBT patients, fatigue, sleepiness, and reduced QOL occurring at the end of brain RT was less with ARM in those patients who were more fatigued at baseline. Toxicity was minimal. These data support conducting a larger phase III study. Analysis of cognitive function data is ongoing. Support - NIH/NCI grant 2U10 CA 81851 and Teva Pharmaceuticals. Clinical trial information: 95709.

scholarly journals Effects of an Oroxylum indicum Extract (Sabroxy®) on Cognitive Function in Adults With Self-reported Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled Study

2021 ◽  
Vol 13 ◽  
Author(s):  
Adrian L. Lopresti ◽  
Stephen J. Smith ◽  
Muhammed Majeed ◽  
Peter D. Drummond
Keyword(s):  
Older Adults ◽  
Cognitive Function ◽  
Word Recall ◽  
Cognitive Tasks ◽  
Controlled Study ◽  
Cognitive Complaints ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Oroxylum Indicum ◽  
Computer Based

Background: Oroxylum indicum has been used in traditional Ayurvedic medicine for the prevention and treatment of several diseases and may have neuroprotective effects.Purpose: Examine the effects of Oroxylum indicum on cognitive function in older adults with self-reported cognitive complaints.Study Design: Two-arm, parallel-group, 12-week, randomized, double-blind, placebo-controlled trial.Methods: Eighty-two volunteers received either 500 mg, twice daily of a standardized Oroxylum indicum extract or placebo. Outcome measures included several computer-based cognitive tasks, the Control, Autonomy, Self-Realization, and Pleasure scale (CASP-19), Cognitive Failures Questionnaire (CFQ), and the Montreal Cognitive Assessment (MoCA). Changes in the concentration of brain-derived neurotrophic factor (BDNF) were also examined.Results: Compared to the placebo, Oroxylum indicum was associated with greater improvements in episodic memory, and on several computer-based cognitive tasks such as immediate word recall and numeric working memory, and a faster rate of learning on the location learning task. However, there were no other significant differences in performance on the other assessed cognitive tests, the MoCA total score, or other self-report questionnaires. BDNF concentrations increased significantly in both groups, with no statistically-significant between-group differences. Oroxylum indicum was well tolerated except for an increased tendency for mild digestive complaints and headaches.Conclusion: The results of this first human trial on the cognitive-enhancing effects of Oroxylum indicum suggest that it is a promising herbal candidate for the improvement of cognitive function in older adults with self-reported cognitive complaints.

scholarly journals Efficacy and Safety of MLC601 in the Treatment of Mild Cognitive Impairment: A Pilot, Randomized, Double-Blind, Placebo-Controlled Study

2017 ◽  
Vol 7 (1) ◽  
pp. 136-142 ◽  
Author(s):  
Hossein Pakdaman ◽  
Ali Amini Harandi ◽  
Mehdi Abbasi ◽  
Hosein Delavar Kasmaei ◽  
Farzad Ashrafi ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Placebo Group ◽  
Mild Cognitive Impairment ◽  
Cognitive Function ◽  
Disease Assessment ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Global Cognitive Function

Background and Aim: Mild cognitive impairment (MCI) is characterized by declined cognitive function greater than that expected for a person’s age. The clinical significance of this condition is its possible progression to dementia. MLC601 is a natural neuroprotective medication that has shown promising effects in Alzheimer disease. Accordingly, we conducted this randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MLC601 in MCI patients. Methods: Seventy-two patients with a diagnosis of MCI were recruited. The included participants were randomly assigned to groups to receive either MLC601 or placebo. An evaluation of global cognitive function was performed at baseline as well as at 3-month and 6-month follow-up visits. Global cognitive function was assessed by Mini-Mental State Examination (MMSE) and Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) scores. Efficacy was evaluated by comparing global function scores between the 2 groups during the study period. Safety assessment included adverse events (AEs) and abnormal laboratory results. Results: Seventy patients completed the study, 34 in the MLC601 group and 36 in the placebo group. The mean changes (±SD) in cognition scores over 6 months in the MLC601 group were –2.26 (±3.42) for the MMSE and 3.82 (±6.16) for the ADAS-cog; in the placebo group, they were –2.66 (±3.43) for the MMSE and 4.41 (±6.66) for the ADAS-cog. The cognition changes based on both MMSE and ADAS-cog scores were statistically significant between the placebo and the MLC601 group (p < 0.001). Only 5 patients (14.7%) reported minor AEs in the MLC601 group, the most commonly reported of which were gastrointestinal, none of them leading to patient withdrawal. Conclusion: MLC601 has shown promising efficacy and acceptable AEs in MCI patients.

scholarly journals Effect of Supplementation of a Whey Peptide Rich in Tryptophan-Tyrosine-Related Peptides on Cognitive Performance in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Study

Nutrients ◽  
2018 ◽  
Vol 10 (7) ◽  
pp. 899 ◽  
Author(s):  
Masahiro Kita ◽  
Kuniaki Obara ◽  
Sumio Kondo ◽  
Satoshi Umeda ◽  
Yasuhisa Ano
Keyword(s):  
Cognitive Function ◽  
Cognitive Decline ◽  
Cognitive Performance ◽  
Healthy Adults ◽  
Controlled Study ◽  
Peptide Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Cognitive Improvement ◽  
Subjective Fatigue

Background: Previous epidemiological and clinical studies have shown that dairy products have beneficial effects on cognitive decline and dementia. Enzymatic digestion of whey protein produces a whey peptide rich in tryptophan-tyrosine-related peptides which improve cognitive performance in mice. We evaluated the effects of whey peptides on cognitive functions in healthy adults in a randomized, double-blind, placebo-controlled design. Methods: 101 healthy adults (45 to 64 years), with a self-awareness of cognitive decline received either whey peptide or placebo supplements for 12 weeks. Changes in cognitive function were assessed using neuropsychological tests at 6 and 12 weeks after the start of supplementation. Results: Verbal fluency test (VFT) score changes tended to be higher in the whey peptide group compared with the placebo at 12 weeks. Subgroup analysis classified by the degree of subjective fatigue showed that changes in the VFT as well as the Stroop and subjective memory function tests between baseline and 6 weeks of intervention were significantly better in subjects with high-level fatigue from the whey peptide group as compared to the placebo group. Conclusions: Intake of whey peptide might improve cognitive function in healthy middle- and older-aged adults with high subjective fatigue levels. Further studies will elucidate the relationship among cognitive improvement, whey peptides, and psychological fatigue.

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