Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in gambling behavior assessed by Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS) |
To assess the severity of gambling-related symptoms: Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS), 10-item clinician-administered questionnaire that assess gambling symptoms over a recent time interval |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Primary |
Change in gambling behavior assessed by Gambling Symptom Assessment Scale (G-SAS) |
a self-rated 5-point Likert scale with total score ranges from 0 to 48 |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Primary |
Change in gambling behavior assessed by TimeLine Follow Back (TLFB) - Gambling Version |
in a multidimension retrospective interview focused on the quantitative assessment of gambling behavior |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Primary |
Change in gambling behavior assessed by Visual Analogue Scale |
an instrument applied to assess continuum variables, using a horizontal line on which the patient shell point his current state from left vertex (no gambling craving) to right vertex (maximum gambling craving). |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in attention / hyperactivity symptoms assessed by Adult ADHD Self-Report Scale (ASRS) |
5-Likert questionnaire to assess the presence of disturbing symptoms attention / hyperactivity |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in emotional awareness assessed by Toronto Alexithymia Scale (TAS-20) |
a self-report 5 point Likert scale with 20 items to assess emotional awareness. The total score goes from 20 to 100: non-alexithymia when the score is less than 51, borderline from 51 to 60 and alexithymia if the score is over 60 |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in mood state assessed by Profile of Mood States (POMS) |
a self-report, 5-point Likert scale to measure the current mood state through six dimensions of affect, including tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in search for sensations assessed by Sensation Seeking Scale V (SSS-V) |
a scale created with the purpose of understanding traits as neuroticism, antisocial behavior and psychopathy. There are four different subscales: Thrill and Adventure Seeking, Disinhibition,Experience Seeking, Boredom Susceptibility. Each subscale contains 10 items, making a total of 40 items |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in hedonic tone assessed by Snaith-Hamilton Pleasure Scale (SHAPS) |
a 14-item 4-point scale with a total score from 0 to 42 |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in hedonic tone assessed by Temporal Experience of Pleasure Scale (TEPS) |
a 18-item 6-point scale with a range from 20 to 108 |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in quality of life assessed by Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) |
to measure the social bonds of the subject with family members, friends, etc; this questionnaire is designed to help assess the degree of enjoyment and satisfaction experienced during the past week. There are 8 subscales : Phisical health, feelings, work, household duties, school/cpurse work, leisure time activities, social relations, general activities. |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in suicidal behaviours assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) |
The scale identifies specific behaviors which may be indicative of an individual's intent to complete suicide. An individual exhibiting even a single behavior identified by the scale was 8 to 10 times more likely to complete suicide |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in psychopathological symptoms assessed by SCL-90 |
measuring both internalizing symptoms (depression, somatization, anxiety) and externalizing ones (aggression, hostility, impulsiveness) of psychiatric patients, general medicine and non-clinical subjects |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in food craving assessed by Food craving questionnaire (FCI) |
a self-report 5-point Likert scale assess to evaluate food craving. The questionnaire consists of 28 items collected in 4 subscale: "high fat foods", "sweets", "carbohydrates", "fast foods" |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in sleep quality assessed by Insomnia severity index (ISI) |
a self-report 5-point Likert questionnaire to estimate sleep quality in the last month. The total score range is from 0 to 28, in particular: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28) |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in nicotine craving assessed by Short Tobacco Craving Questionnaire (sTCQ) |
a Likert based scale (1-7 score) to evaluate nicotine craving. The questionnaire consisted in 4 domines (emotionally, expectancy, compulsivity, purposufullness), each with 3 items |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in anxiety level assessed by Hamilton Anxiety Scale (HAM-A) |
a 14-item 5-point scale with a total range score from 0 (min ) to 56 (max), that assesses anxiety symptoms exploring different domains "anxious mood", "tension" or "fears" |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in depressive symptoms assessed by Hamilton Depression Scale (HAM-D) |
a interview with 20 items and total score is considered normal with range 0-7 |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in manic symptoms assessed by Young Mania Rating Scale (YMRS) |
a 11-item interview with total range score form 0 to 60 |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in positive and negative symptoms assessed by Positive Affect and Negative Affect Scales (PANAS) |
to measure any possible Collateral effect. PANAS is a 20-items 5-poin Likert questionnaire consisted in 2 subscale: Positive Affect Score and Negative Affect Score, with total range from 10 to 50 for each domains |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in impulsivness assessed by Barratt Impulsiveness Scale (BIS-11) |
a 11-items self-report questionnaire to evaluate temperamental impulsive traits. BIS-11 consists in 3 subscale: "Attentional Impulsivity", "Motor Impulsivity" and "Nonplanning Impulsivity" |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in cognitive performance by Iowa gambling task (IGT) |
a psychological task thought to simulate real-life decision making. Participants are presented with four virtual decks of cards on a computer screen. They are told that each deck holds cards that will either reward or penalize them, using game money. The goal of the game is to win as much money as possible. The decks differ from each other in the balance of reward versus penalty cards |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in cognitive performance by Go / No-Go Task |
used to measure a participants capacity for sustained attention and response control. For example, a go/no-go test that requires a participant to perform an action given certain stimuli (e.g., press a button - Go) and inhibit that action under a different set of stimuli (e.g., not press that same button - No-Go). |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in cognitive performance by Stroop color-word task |
a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect |
Baseline, after rTMS treatment (5 day), 4 weeks |
|
| Secondary |
Change in cognitive performance by Wisconsin card-sorting task |
a neuropsychological test of "set-shifting", i.e. the ability to display flexibility in the face of changing schedules of reinforcement. A number of stimulus cards are presented to the participant. The original WCST used paper cards and was carried out with the experimenter on one side of the desk facing the participant on the other |
Baseline, after rTMS treatment (5 day), 4 weeks |
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