University of Salamanca — Biomedical Watch V2

Traitements4programmes

Essais2liés

Publications4liées

SourceDBlocale

Traitements

4

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's DiseaseThis study is a randomized, parallel-group, single blinded controlled clinical trial. The general objective of this multicomponent physical exercise program (MPEP) associated with a Mediterranean Diet (MeDi) is to decrease the risk of falls and fractures through the improvement of the bone health and physical functions of people with Alzheimer Disease. Patients allocated to the intervention group will perform a MPEP with a MeDi during 6 months, with a frequency of 3 sessions per week, and approximately 45-50 minutes of duration each session. During the study, 4 evaluations will be carried out to assess the effects of the interventions on bone mineral density, gait, balance, and fall risk: ((1) Baseline (pre-intervention); 2) 1st post-intervention after 1 month; 3) 2nd post-intervention after 3 months; 4) Final, 3rd post-intervention after 6 months	Alzheimer	NA	À vérifier	Spain	À vérifier
Neurofeedback for Episodic MigraineBackground: Migraine is a highly prevalent neurological disorder and one of the leading causes of disability worldwide, particularly among women of reproductive age. It is associated with substantial clinical, psychological, and socioeconomic burden, including increased risk of vascular and psychiatric comorbidities, reduced quality of life, sleep disturbances, and decreased productivity. Neurofeedback (NF) has emerged as a promising non-pharmacological intervention aimed at promoting self-regulation of brain activity through real-time feedback and neuroplasticity mechanisms. Objective: This study aims to evaluate the effectiveness of neurofeedback as an adjunct therapy in reducing the frequency and severity of high-frequency episodic migraine in adults. Secondary objectives include assessing changes in medication use, sleep quality, disability and functional impact, depressive symptoms, and the influence of common migraine triggers. Methods: A randomized controlled trial with two parallel groups will be conducted at the University Hospital of Salamanca. Participants will be adults (\>18 years) diagnosed with episodic migraine (5-14 days/month). A total of 66 participants will be randomly assigned (1:1) to either a neurofeedback intervention group or a control group. The intervention consists of 60 neurofeedback sessions over 12 weeks, including EEG-based training aimed at reducing high beta activity (21-30 Hz) and increasing alpha activity (8-12 Hz), as well as blood volume pulse biofeedback. The control group will receive no additional intervention. Primary outcomes include migraine frequency and severity, while secondary outcomes encompass medication use, disability (MIDAS, HIT-6), sleep quality (PSQI), quality of life (MSQ), depressive symptoms (PHQ-9), and trigger-related variables. Assessments will be performed at baseline, 3 months, and 6 months. Data will be analyzed using repeated-measures mixed models (SPSS v28). Expected Results: It is hypothesized that neurofeedback will significantly reduce migraine frequency and severity compared to control conditions, and improve associated functional, psychological, and sleep-related outcomes. Conclusions: This trial aims to provide robust evidence on the efficacy of neurofeedback as a complementary therapeutic approach for migraine, addressing the current need for well-designed randomized controlled studies in this field.	Migraine	Non applicable	Traitement symptomatique	Spain	À vérifier
Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's DiseaseThis study is a randomized, parallel-group, single blinded controlled clinical trial. The general objective of this multicomponent physical exercise program (MPEP) associated with a Mediterranean Diet (MeDi) is to decrease the risk of falls and fractures through the improvement of the bone health and physical functions of people with Alzheimer Disease. Patients allocated to the intervention group will perform a MPEP with a MeDi during 6 months, with a frequency of 3 sessions per week, and approximately 45-50 minutes of duration each session. During the study, 4 evaluations will be carried out to assess the effects of the interventions on bone mineral density, gait, balance, and fall risk: ((1) Baseline (pre-intervention); 2) 1st post-intervention after 1 month; 3) 2nd post-intervention after 3 months; 4) Final, 3rd post-intervention after 6 months	Alzheimer	NA	À vérifier	Spain	À vérifier
Neurofeedback for Episodic MigraineBackground: Migraine is a highly prevalent neurological disorder and one of the leading causes of disability worldwide, particularly among women of reproductive age. It is associated with substantial clinical, psychological, and socioeconomic burden, including increased risk of vascular and psychiatric comorbidities, reduced quality of life, sleep disturbances, and decreased productivity. Neurofeedback (NF) has emerged as a promising non-pharmacological intervention aimed at promoting self-regulation of brain activity through real-time feedback and neuroplasticity mechanisms. Objective: This study aims to evaluate the effectiveness of neurofeedback as an adjunct therapy in reducing the frequency and severity of high-frequency episodic migraine in adults. Secondary objectives include assessing changes in medication use, sleep quality, disability and functional impact, depressive symptoms, and the influence of common migraine triggers. Methods: A randomized controlled trial with two parallel groups will be conducted at the University Hospital of Salamanca. Participants will be adults (\>18 years) diagnosed with episodic migraine (5-14 days/month). A total of 66 participants will be randomly assigned (1:1) to either a neurofeedback intervention group or a control group. The intervention consists of 60 neurofeedback sessions over 12 weeks, including EEG-based training aimed at reducing high beta activity (21-30 Hz) and increasing alpha activity (8-12 Hz), as well as blood volume pulse biofeedback. The control group will receive no additional intervention. Primary outcomes include migraine frequency and severity, while secondary outcomes encompass medication use, disability (MIDAS, HIT-6), sleep quality (PSQI), quality of life (MSQ), depressive symptoms (PHQ-9), and trigger-related variables. Assessments will be performed at baseline, 3 months, and 6 months. Data will be analyzed using repeated-measures mixed models (SPSS v28). Expected Results: It is hypothesized that neurofeedback will significantly reduce migraine frequency and severity compared to control conditions, and improve associated functional, psychological, and sleep-related outcomes. Conclusions: This trial aims to provide robust evidence on the efficacy of neurofeedback as a complementary therapeutic approach for migraine, addressing the current need for well-designed randomized controlled studies in this field.	Migraine	Non applicable	Traitement symptomatique	Spain	À vérifier

Essais cliniques

2

Molécule	Indication / population	Phase	NCT	Titre	Statut
Neurofeedback for Episodic Migraine	Migraine	Non applicable	NCT07661888	Neurofeedback for Episodic Migraine	NOT_YET_RECRUITING
Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's Disease	Alzheimer	NA	NCT04439097	Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's Disease	UNKNOWN

Publications

4

Molécule	Indication / population	Titre	Journal	Date
Neurofeedback for Episodic Migraine		Neurofeedback and biofeedback with 37 migraineurs: a clinical outcome study.	Behavioral and brain functions : BBF
Neurofeedback for Episodic Migraine		Biofeedback in the prophylactic treatment of medication overuse headache: a pilot randomized controlled trial.	The journal of headache and pain
Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's Disease		Short and medium-term effects of a multicomponent physical exercise program with a Mediterranean diet on bone mineral density, gait, balance, and fall risk for patients with Alzheimer disease: Randomized controlled clinical trial study protocol.	Medicine
Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's Disease		Food resources and kitchen skills plus aerobic training (FoRKS+) for black adults with hypertension: A pilot trial protocol.	Contemporary clinical trials