Accelerated rTMS in Gambling Disorder: a Multicentric, Randomized, Sham-controlled Trial
NCT05016479, Not applicable, Unknown, ITAB - Institute for Advanced Biomedical Technologies
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Accelerated rTMS in Gambling Disorder: a Multicentric, Randomized, Sham-controlled Trial | ClinicalTrials.gov |
| NCT number | NCT05016479 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | ITAB - Institute for Advanced Biomedical Technologies | ClinicalTrials.gov |
| Conditions | Gambling, Gambling Disorder, Gambling, Pathological, Gambling Problem | ClinicalTrials.gov |
| Interventions | Accelerated repetitive Transcranial Magnetic Stimulation | ClinicalTrials.gov |
| First posted | 2021-08-23 | ClinicalTrials.gov |
| Last updated | 2021-10-26 | ClinicalTrials.gov |
Registered outcomes 25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in gambling behavior assessed by Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS) | Baseline, after rTMS treatment (5 day), 4 weeks | 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 | ClinicalTrials.gov |
| Primary | Change in gambling behavior assessed by Gambling Symptom Assessment Scale (G-SAS) | Baseline, after rTMS treatment (5 day), 4 weeks | a self-rated 5-point Likert scale with total score ranges from 0 to 48 | ClinicalTrials.gov |
| Primary | Change in gambling behavior assessed by TimeLine Follow Back (TLFB) - Gambling Version | Baseline, after rTMS treatment (5 day), 4 weeks | in a multidimension retrospective interview focused on the quantitative assessment of gambling behavior | ClinicalTrials.gov |
| Primary | Change in gambling behavior assessed by Visual Analogue Scale | Baseline, after rTMS treatment (5 day), 4 weeks | 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). | ClinicalTrials.gov |
| Secondary | Change in attention / hyperactivity symptoms assessed by Adult ADHD Self-Report Scale (ASRS) | Baseline, after rTMS treatment (5 day), 4 weeks | 5-Likert questionnaire to assess the presence of disturbing symptoms attention / hyperactivity | ClinicalTrials.gov |
| Secondary | Change in emotional awareness assessed by Toronto Alexithymia Scale (TAS-20) | Baseline, after rTMS treatment (5 day), 4 weeks | 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 | ClinicalTrials.gov |
| Secondary | Change in mood state assessed by Profile of Mood States (POMS) | Baseline, after rTMS treatment (5 day), 4 weeks | 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 | ClinicalTrials.gov |
| Secondary | Change in search for sensations assessed by Sensation Seeking Scale V (SSS-V) | Baseline, after rTMS treatment (5 day), 4 weeks | 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 | ClinicalTrials.gov |
| Secondary | Change in hedonic tone assessed by Snaith-Hamilton Pleasure Scale (SHAPS) | Baseline, after rTMS treatment (5 day), 4 weeks | a 14-item 4-point scale with a total score from 0 to 42 | ClinicalTrials.gov |
| Secondary | Change in hedonic tone assessed by Temporal Experience of Pleasure Scale (TEPS) | Baseline, after rTMS treatment (5 day), 4 weeks | a 18-item 6-point scale with a range from 20 to 108 | ClinicalTrials.gov |
| Secondary | Change in quality of life assessed by Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) | Baseline, after rTMS treatment (5 day), 4 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in suicidal behaviours assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline, after rTMS treatment (5 day), 4 weeks | 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 | ClinicalTrials.gov |
| Secondary | Change in psychopathological symptoms assessed by SCL-90 | Baseline, after rTMS treatment (5 day), 4 weeks | measuring both internalizing symptoms (depression, somatization, anxiety) and externalizing ones (aggression, hostility, impulsiveness) of psychiatric patients, general medicine and non-clinical subjects | ClinicalTrials.gov |
| Secondary | Change in food craving assessed by Food craving questionnaire (FCI) | Baseline, after rTMS treatment (5 day), 4 weeks | 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" | ClinicalTrials.gov |
| Secondary | Change in sleep quality assessed by Insomnia severity index (ISI) | Baseline, after rTMS treatment (5 day), 4 weeks | 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) | ClinicalTrials.gov |
| Secondary | Change in nicotine craving assessed by Short Tobacco Craving Questionnaire (sTCQ) | Baseline, after rTMS treatment (5 day), 4 weeks | 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 | ClinicalTrials.gov |
| Secondary | Change in anxiety level assessed by Hamilton Anxiety Scale (HAM-A) | Baseline, after rTMS treatment (5 day), 4 weeks | 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" | ClinicalTrials.gov |
| Secondary | Change in depressive symptoms assessed by Hamilton Depression Scale (HAM-D) | Baseline, after rTMS treatment (5 day), 4 weeks | a interview with 20 items and total score is considered normal with range 0-7 | ClinicalTrials.gov |
| Secondary | Change in manic symptoms assessed by Young Mania Rating Scale (YMRS) | Baseline, after rTMS treatment (5 day), 4 weeks | a 11-item interview with total range score form 0 to 60 | ClinicalTrials.gov |
| Secondary | Change in positive and negative symptoms assessed by Positive Affect and Negative Affect Scales (PANAS) | Baseline, after rTMS treatment (5 day), 4 weeks | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Go/No-Go Task | Secondary outcome | ConductCognition |
| Iowa Gambling Lite | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)