An observational study in Anorexia Nervosa and Parkinson Disease, sponsored by Istituto Auxologico Italiano. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-21.
Sponsored by Istituto Auxologico Italiano · Observational
Among 18 studies in Anorexia Nervosa by Istituto Auxologico Italiano — 4 open to participants now, 4 under way, none of them phase 3. Anorexia Nervosa · Istituto Auxologico Italiano.
Among the 18 studies in Anorexia Nervosa by Istituto Auxologico Italiano, this one is the 3rd largest by planned enrollment of the 15 observational ones that give a count, is one of 6 that started in 2023, is one of 15 observational ones, and was the 9th registered.
469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.
Browse Anorexia Nervosa studies →4 of the 18 studies in Anorexia Nervosa by Istituto Auxologico Italiano are open now, in 1 country. Recruiting first, the newest first:
Istituto Auxologico Italiano · Sites in Italy
Ages 16–65
Istituto Auxologico Italiano · Sites in Italy
Ages 18–65
Istituto Auxologico Italiano
Ages 18+
By country, each count listing its studies:
Of the 83 Anorexia Nervosa studies recruiting now, 18 (22%) set no upper age limit and 61 (73%) stop at 75 or younger; 48 take children under 18; 26 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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18 studies; the count open now beside each. This study's row is marked.
First in 2019; this study’s year is marked. 6 started in 2023.
This study's planned enrollment of 80 is close to the median of 78 across 142 observational studies indexed under Anorexia Nervosa.
Median enrollment 54 across the 3 interventional studies, 60 across the 15 observational. Of the 12 that completed or were terminated, 0 (0%) have results posted.
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Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 68 are open to participants now.
1 of the studies in Anorexia Nervosa by Istituto Auxologico Italiano that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07295470Istituto Auxologico ItalianoSleep and Activity For Eating Disorders | 2027-05 |
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Among the 18 studies in Anorexia Nervosa by Istituto Auxologico Italiano, from their registry updates:
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The main aim of this study is to demonstrate how disorders characterized by different types of "inflexibility", cognitive-affective type for Anorexia nervosa and motor one for Parkinson's disease, have an impact on how emotional stimuli are processed and on the transition within emotional states.
Although many psychometric models have been developed on emotions, affect measurements, which represent the measurement of behavioural, subjective and neuropsychophysiological changes associated with an emotional episode, still remains one of the most debated topics. Emotions are entities with blurred boundaries and with substantial idiosyncrasies that characterize their measurable manifestations. One of the most consolidated theoretical reference models for measuring affect is that of James Russel called the "Affective Core Model". According to this model, emotion arises when the undifferentiated and pre-reflective magma of affect (core affect) is attracted by an external (or internal) object that can be defined as emotigenic, i.e. capable of defining the nature of emotional experience by orienting it along two dimensions principal factors. The most used theoretical model for affect measurement is the one that describes an emotional episode in the light of two distinguishable continuous dimensions: that of hedonic value (identifies the degree of pleasantness of the emotional event), of a subjective nature, and that of arousal or psychophysiological activation. Although this model has been widely corroborated in various disciplines, there is still a lack of a clear description of the process that allows an individual to transition from one emotionally object-oriented state to another.
This project proposes and intends to validate a new modality of three-dimensional psychometric modeling of emotions, based on the intersection between the consolidated two-dimensional model of arousal-valence and a third purely cognitive component definable as mental flexibility, capable of including high-level cognitive processes, intrinsically connected with the emotional sphere, such as emotional intelligence (Emotional Intelligence, EI) and emotional regulation.
Patients affected by Parkinson's Disease and Anorexia Nervosa
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The trial will be divided into two periods T0 (first evaluation at the time of admission to hospital) and T1 (15 days after T0, during rehabilitation period in hospital for patients with Parkinson's disease). First, as soon as patients are admitted to acute care,neuropsychological tests and self-report questionnaires will be administered. Subsequently, at both T0 and T1, standardized emotional images from the International Affective Picture System (IAPS) will be administered. For the entire duration of the test, peripheral physiological parameters such as ECG, BVP, GSR, EOG, RSP and facial EMG (corrugator and zygomaticus) will also be detected, as objective measures of emotional arousal (T0-T1).
Diagnostic Test: Neuropsychological tests in PD · Diagnostic Test: Self-report questionnaires in PD · Device: International Affective Picture System (IAPS)
The trial will be divided into two periods T0 (first evaluation at the time of admission to hospital) and T1 (4 weeks after T0, during rehabilitation period in hospital. First, as soon as patients are admitted to acute care, neuropsychological tests and self-report questionnaires will be administered. Subsequently, at both T0 and T1, standardized emotional images from the International Affective Picture System (IAPS) will be administered. For the entire duration of the test, peripheral physiological parameters such as ECG, BVP, GSR, EOG, RSP and facial EMG (corrugator and zygomaticus) will also be detected, as objective measures of emotional arousal (T0-T1). Furthermore, the analysis of bio-humoral parameters (interleukin 6, cortisol, serotonin, catecholamines and endorphins) will be also performed through morning venous blood sampling at T0, at half of the rehabilitation process and at T1.
Device: International Affective Picture System (IAPS) · Diagnostic Test: Neuropsychological tests in AN · Diagnostic Test: Self-report questionnaires in AN · Diagnostic Test: Analysis of bio-humoral parameters
Colored Progressive Matrices (BDM), Stroop Test (Caffarra et al., 2000), Stroop Test (Caffarra et al., 2000), Attentional Matrices (part I - Della Sala et al., 1992), Attentional Matrices (part The - Della Sala et al., 1992), Trail Making Test (Giovagnoli et al., 1996 - part A), Trail Making Test (Giovagnoli et al., 1996 - part B), Trail Making Test (Giovagnoli et al., 1996 - B-A), MMSE (Grigoletto et al., 1999), Clock Drawing - PD (Caffarra et al., 2011), Digit Span Forward (Orsini et al., 1987), Digit Span Backward (Monaco et al. , 2012), 15 Rey Words - Immediate Recall (BDM), 15 Rey Words - Deferred Recall (BDM), Phonemic Fluency (Costa et al., 2014), Semantic Fluency (Costa et al., 2014), Frontal Assessment Battery ( FAB - Apollonio et al.,2005).
STAI Y2 (trait anxiety), TEIque (153 items), STAI Y1 (state anxiety), ERQ (10 items), EISR (33 items), BDI (21 items), WLEIS (16 ITEMS), CFI (20 ITEMS ), CCFQ (18 ITEM).
Subsequently, at both T0 and T1, standardized emotional images from the International Affective Picture System (IAPS) will be administered. The images will be chosen based on the arousal-valence parameters, eliminating those with stimuli that are too salient with respect to the disorders examined. The order of administration will be organized and randomized between subjects as follows: 24 blocks of 2 minutes and for each block there will be 12 images of 10 seconds each. For the entire duration of the test, peripheral physiological parameters such as ECG, BVP, GSR, EOG, RSP and facial EMG (corrugator and zygomaticus) will also be detected, as objective measures of emotional arousal (T0-T1).
Verbal Fluencies, Tower of London, TMT-A \& B
STAI Y2 (20 items trait anxiety), TEIque (153 items), STAI Y1 (20 items state anxiety), DFlex (24 items), ERQ (10 items), EISR (33 items), BDI (21 items), TAS-20 (20 items), WLEIS (16 ITEMS), CFI (20 ITEMS), CCFQ (18 items).
the analysis of bio-humoral parameters (interleukin 6, cortisol, serotonin, catecholamines and endorphins) will be also performed through morning venous blood sampling at T0, at half of the rehabilitation process and at T1
Change in International Affective Picture System (IAPS)
Self-Assessment Manikin (SAM) scale. Range score for each image: 1-5 (IAPS test: 24 blocks of 2 minutes and for each block there will be 12 images of 10 seconds each).
Time frame: At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
Change in self-report questionnaires - STAI
State-Trait Anxiety Inventory (STAI); score range 20-80
Time frame: At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
Change in self-report questionnaires - BDI
Beck's Depression Inventory (BDI); score range 0-63
Time frame: At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
Change in Heart rate variability
High frequency (range 0.15-0.40 hz) * Low frequency (range 00.4-0.15 hz) * Ratio Low frequency/High frequency
Time frame: At baseline T0 (hospital admission) and T1 (15 days after T0 for PD, 4 weeks after T0 for AN)
Change in analysis of bio-humoral parameters
Serotonin in serum (range 30 - 200 ng/ml)
Time frame: At baseline T0 (hospital admission), after 2 weeks and T1 (4 weeks after T0 for AN)
Started Jan 2023 (actual). Primary completion is estimated for Aug 2024, 19 months after the start.
Of 56 non-industry observational studies under Anorexia Nervosa, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 72. This study's planned 19 months is below that.
Counting every sponsor, half of 56 studies reached it within 38 months; a quarter within 16 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
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