Gambling DisorderNCT03336879
Repetitive Transcranial Magnetic Stimulation in Gambling Disorder
A study testing Repetitive Transcranial Magnetic Stimulation in people with Gambling Disorder, run by ITAB - Institute for Advanced Biomedical Technologies at 2 sites in Italy.
Trial summary
Background: An imbalance between prefrontal cortex (PFC) and the mesolimbic reward system has been suggested to contribute to GD. GD patients showed increased functional connectivity between regions of the PFC and mesolimbic reward system, as well as reduced connectivity in the area of the PFC. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gambling Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Nov 2017to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 65;
- Current diagnosis of Gambling Disorder, based on the Diagnostic and Statistical Manual of Mental Disorder - Fifth Edition (DSM-5);
- Drug-free.
Who cannot join
- Current DSM-V diagnosis of substance use disorders other than nicotine dependence;
- Current DSM-V diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder;
- Use in the past 4 weeks of any medication with known pro-convulsant action; or current regular use of any psychotropic medications (benzodiazepines, antipsychotic medications, tricyclic antidepressants, anti-epileptics, mood stabilizers);
- Any history of any clinically significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes;
- Any personal or family history (1st degree relatives) of seizures other than febrile childhood seizures;
- Any psychiatric, medical or social condition whether or not listed above, due to which, in the judgment of the PI and after any consults if indicated, participation in the study is not in the best interest of the patient;
- For female patients: Pregnancy/breastfeeding.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Department of Neuroscience, Imaging and Clinical Sciences
Chieti, 66100
Givoanni Martinotti, MD, PhD, 0039 335 5627362, giovanni.martinotti@gmail.com
Chiara Montemitro, MD, 0039 3281264713, chiara.montemitro@gmail.com
- Not yet recruiting
La Promessa ONLUS
Roma, 00192
Mauro Pettorruso, MD, 039 339 1979487, mauro.pettorruso@hotmail.it
Mauro Pettorruso, MD
About this study
Official title: Exploring the Potential of High-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) to Treat Gambling Disorder (GD)
Background: An imbalance between prefrontal cortex (PFC) and the mesolimbic reward system has been suggested to contribute to GD. GD patients showed increased functional connectivity between regions of the PFC and mesolimbic reward system, as well as reduced connectivity in the area of the PFC. The altered interaction between prefrontal structures and the mesolimbic reward system in GD shares similarity with functional organization reported in Substances Use Disorders (SUDs), suggesting a more general pathophysiology for addictive disorders
Objectives: To test if rTMS can reduce craving and playing in Gambling Disorder, and also affect several mood, behavioral and cognitive alterations associated with prolonged Gambling Disorder.
Read more
Eligibility: Healthy, right-handed adults ages 18-65 who do have Gambling Disorder.
Design: This is a non-randomized, open label study. The study includes three phases: 1) a rTMS continued treatment phase; 2) a rTMS follow-up; and 3) a no rTMS follow-up.
Prior to participating, participants will be screened with:
- Questionnaires
- Cognitive tests
- Medical history
- Physical exam
After being enrolled, baseline behavioral and imaging data will be collected. In particular, participants will undergo:
- Questionnaires
- Cognitive tests
During the continued rTMS phase, participants with Gambling Disorder will receive real rTMS. Repetitive TMS will be delivered during 10 outpatient treatment days, over 2 weeks (5 days/week). Following this phase, subjects will have 12 follow-up visits (once/weekly), during which they will receive rTMS, and behavioral assessments will be performed. At the end of the rTMS follow up period, participants will further receive 3 follow up visits (once a month), during which rTMS will not be performed, but behavioral data will be collected.
Treatment includes:
- rTMS: A coil is placed on the head. Brief electrical current passes through the coil. At each visit, participants will receive two rTMS sessions, with a 1hr interval between sessions. At the beginning of each rTMS session, they view gambling-related images for few minutes.
- Repeat of screening tests and questionnaires
Read the detailed description
Gambling Disorder (GD) is a complex addictive disorder involving fronto-striatal connectivity and prefrontal top-down control modulation of reward-related brain areas. Repetitive transcranial magnetic stimulation (rTMS) seems to reduce cravings and improve cognitive function in substance dependent individuals. Moreover, rTMS has been shown to modulate dopaminergic and glutamatergic transmission, both involved in GD pathophysiology. However, the efficacy of rTMS in treating GD has not been evaluated and also, we lack a full characterization of rTMS effects on other important aspects, including effects on mood, cognition and changes in brain function. The purpose of this study is to investigate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) at 15 Hz frequency on the left dorsolateral prefrontal cortex in patients affected by GD and to examine possible changes in mood, cognition, and brain activity and functional connectivity associated with this intervention. For this purpose, the investigators will recruit GD patients. After screening and informed consent, participants will undergo active rTMS for two consecutive weeks (twice a day) during the continued treatment phase, and a maintenance intervention (twice a week for 3 months), during the rTMS follow-up phase. Following this phase, participants will be followed for further 3 months, during which no rTMS will be delivered but clinical data will be collected.
Procedure: The project consists of: Screening Visit (baseline), Phase 1 (continued treatment phase), Phase 2 (3 months- rTMS follow-up), Phase 3 (3 months follow-up without rTMS). First, there will be a screening visit, where a clinical interview will be conducted and questionnaires and tests will be administered to identify study participants who meet the inclusion and exclusion criteria. Baseline clinical and cognitive data will be acquired. In Phase 1, participants will receive 2 sessions of rTMS (active), twice per day for 10 consecutive days, for a total of 20 rTMS sessions. Following this, the investigators will evaluate the acute effect of treatment on relapse rate, gambling severity and craving, mood and cognition. In Phase 2 of the study, all participants will continue the treatment arm with rTMS (15Hz) for three months. Participants will receive 2 sessions of rTMS (active) once per week; clinical and cognitive data will be acquired once per month. The investigators will evaluate the acute effect of treatment on relapse rate, gambling severity and craving, mood and cognition. In Phase 3 of the study, participants will not receive any rTMS session. Clinical and cognitive data will be acquired once per month for three months. The investigators will evaluate the long-term effect of treatment on relapse rate, gambling severity and craving, mood and cognition.
- Conditions
- Gambling Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- Gambling Disorder, Mental Disorder, Behavioral Addiction
- Medical subject headings
- Gambling, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Also called rTMS
Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation technique. The investigators will use a MagPro R30 with the Cool-B80 figure-of-eight coil (MagVenture, Falun, Denmark).
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS (15 Hz) | Experimental | The intervention will be Repetitive Transcranial Magnetic Stimulation. Each patient will receive active stimulation targeting the left dorsolateral prefrontal cortex (lDLPFC) with a frequency of 15 Hz and 100% of the individual resting motor threshold, for a total of 40 trains (60 stimuli per train, inter-train interval of 15 second, total duration 13 minutes). Each session will be repeated twice/daily for 10 consecutive days for 2 weeks, during the continued treatment phase. Following this, the participants will receive the maintenance intervention of 2 sessions per week for 3 months (rTMS follow-up), at the same parameters described above. Device: MagPro R30 with the Cool-B80 figure-of-eight coil (MagVenture, Falun, Denmark). Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Visual Analogue Scale for Craving (VAS-craving)
A Visual Analogue Scale (VAS) is an instrument to measure a characteristic or attitude that is believed to range across a continuum of values. The VAS is a horizontal line, 100 mm in length, anchored by word descriptors at each end (0 = lower scores; 10 = higher scores). The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left-hand end of the line to the point that the patient marks.
Measured: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months
Changes in the Pathological Gambling Adaptation of the Yale-Brown Obsessive-Compulsive Scale (PG-YBOCS)
The Pathological Gambling Adaptation of the Yale-Brown Obsessive-Compulsive Scale (PG-YBOCS) is a 10-item clinician-administered questionnaire that measures the severity of PG over the past one week. Scores from 0 (min) to 4 (max) are assigned according to the severity. The first set of questions (questions 1-5) assess urges and thoughts associated with pathological gambling, whereas the last five questions assess the behavioral component of the disorder. Both single set scores and total score will be calculated.
Measured: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months
Changes in Gambling Disorder Severity as assessed by Timeline Follow Back (TLFB)
Gambling behavior will be assessed using the TimeLine Follow Back (TLFB). TLFB is an interview-based assessment. Using a calendar, participants are guided through the process of recalling and reporting daily gambling behavior. TLFB provides measures of gambling episodes per week, gambling days per week, heavy gambling days per week.
Measured: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months
Changes in Gambling Behavior as assessed by Gambling Symptom Assessment Scale (G-SAS) Total Score
Gambling Symptom Assessment Scale (G-SAS) is a 12-item self-rated scale designed to assess gambling symptom severity and change during treatment. Each 12-item scale has a score ranging from 0 - 4 (adjective anchors for 0 and 4 vary for each item). All items ask for an average symptom based on the past 7 days. Total score ranges from 0 (min) to 48 (max), higher scores indicate higher severity levels.
Measured: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months
Secondary outcomes (6)
Changes in the Iowa Gambling Task (IGT) Performance
The Iowa Gambling Task is a computerized card game commonly used to measure risky decision-making tendencies and sensitivity to reward and loss. Performance is calculated on the total net score results from the subtraction of the disadvantageous deck choices from the advantageous deck choices during the entire test ([C'+D']-[A'+B']).
Measured: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months
Changes in Snaith Hamilton Pleasure Scale (SHAPS) Total Score
The Snaith Hamilton Pleasure Scale (SHAPS) is a 14-item self-report scale designed to measure hedonic-tone/anhedonia. Each item is scored on a 4-point scale, ranging from 0 (not at all) to 3 (extremely). Sum the scores from all 14 parameters gives the SHAPS Total Score which may range from 0 (min) to 42 (max).
Measured: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months
Changes in Temporal experience of Pleasure Scale (TEPS) Total
The Temporal experience of Pleasure Scale (TEPS) is a 18-item self-report scale designed to evaluate individual trait dispositions in anticipatory and consummatory pleasure experiences. Each item is scored on a 6-point scale, ranging from 1 (extremely false) to 6 (extremely true). Sum the scores from all 20 parameters gives the TEPS Total Score which may range from 20 (min) to 108 (max).
Measured: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months
Changes in Montgomery-Asberg Depression Scale (MADRS) Total
The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
Measured: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months]
Changes in Hamilton Rating Scale for Anxiety (HAM-A) Total
The HAM-A is a 14-item scale that assesses anxiety symptoms of anxiety such as "anxious mood", "tension" or "fears". Each item is scored on a 5-point scale, ranging from 0 (not present) to 4 (severe). Sum the scores from all 14 parameters gives the HAM-A Total Score which may range from 0 (min) to 56 (max).
Measured: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months
Changes in Profile of Mood States (POMS), Total Mood Disturbance Score
The profile of mood state (POMS) is a questionnaire designed to measure present mood state by a list of adjectives on a 5-point Likert scale (0 = not at all; 4 = Extremely) and measures six dimensions of affect, including tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. The measure has been shown to produce reliable and valid profiles of mood state. A Total Mood Disturbance Score may be calculated by adding the scores for Tension, Depression, Anger, Fatigue and Confusion and then subtracting the score for Vigor.
Measured: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Nov 2017
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gambling DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- non-randomized, open label study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ITAB - Institute for Advanced Biomedical Technologies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Martinotti, ITAB - Institute for Advanced Biomedical Technologies
- Investigators
- Massimo di Giannantonio, MD, Principal investigator, Department of Neuroscience, Imaging and Clinical Sciences (ITAB) - University G. d'Annunzio - Chieti (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336879
- Sponsor's protocol ID
- v.2_19/10/2017
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pettorruso M, Martinotti G, Montemitro C, De Risio L, Spagnolo PA, Gallimberti L, Fanella F, Bonci A, Di Giannantonio M; Brainswitch Study Group. Multiple Sessions of High-Frequency Repetitive Transcranial Magnetic Stimulation as a Potential Treatment for Gambling Addiction: A 3-Month, Feasibility Study. Eur Addict Res. 2020;26(1):52-56. doi: 10.1159/000504169. Epub 2019 Oct 30.
PubMed 31665732
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Potential of High-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) to Treat Gambling Disorder (GD)
- ClinicalTrials.gov ID
- NCT03336879
- Acronym / sponsor ID
- v.2_19/10/2017
- Conditions
- Gambling Disorder
- Keywords
- Gambling Disorder, Mental Disorder, Behavioral Addiction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- ITAB - Institute for Advanced Biomedical TechnologiesUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: An imbalance between prefrontal cortex (PFC) and the mesolimbic reward system has been suggested to contribute to GD. GD patients showed increased functional connectivity between regions of the PFC and mesolimbic reward system, as well as reduced connectivity in the area of the PFC. The altered interaction between prefrontal structures and the mesolimbic reward system in GD shares similarity with functional organization reported in Substances Use Disorders (SUDs), suggesting a more general pathophysiology for addictive disorders
Objectives: To test if rTMS can reduce craving and playing in Gambling Disorder, and also affect several mood, behavioral and cognitive alterations associated with prolonged Gambling Disorder.
Eligibility: Healthy, right-handed adults ages 18-65 who do have Gambling Disorder.
Design: This is a non-randomized, open label study. The study includes three phases: 1) a rTMS continued treatment phase; 2) a rTMS follow-up; and 3) a no rTMS follow-up.
Prior to participating, participants will be screened with:
- Questionnaires
- Cognitive tests
- Medical history
- Physical exam
After being enrolled, baseline behavioral and imaging data will be collected. In particular, participants will undergo:
- Questionnaires
- Cognitive tests
During the continued rTMS phase, participants with Gambling Disorder will receive real rTMS. Repetitive TMS will be delivered during 10 outpatient treatment days, over 2 weeks (5 days/week). Following this phase, subjects will have 12 follow-up visits (once/weekly), during which they will receive rTMS, and behavioral assessments will be performed. At the end of the rTMS follow up period, participants will further receive 3 follow up visits (once a month), during which rTMS will not be performed, but behavioral data will be collected.
Treatment includes:
- rTMS: A coil is placed on the head. Brief electrical current passes through the coil. At each visit, participants will receive two rTMS sessions, with a 1hr interval between sessions. At the beginning of each rTMS session, they view gambling-related images for few minutes.
- Repeat of screening tests and questionnaires
Detailed description
Gambling Disorder (GD) is a complex addictive disorder involving fronto-striatal connectivity and prefrontal top-down control modulation of reward-related brain areas. Repetitive transcranial magnetic stimulation (rTMS) seems to reduce cravings and improve cognitive function in substance dependent individuals. Moreover, rTMS has been shown to modulate dopaminergic and glutamatergic transmission, both involved in GD pathophysiology. However, the efficacy of rTMS in treating GD has not been evaluated and also, we lack a full characterization of rTMS effects on other important aspects, including effects on mood, cognition and changes in brain function. The purpose of this study is to investigate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) at 15 Hz frequency on the left dorsolateral prefrontal cortex in patients affected by GD and to examine possible changes in mood, cognition, and brain activity and functional connectivity associated with this intervention. For this purpose, the investigators will recruit GD patients. After screening and informed consent, participants will undergo active rTMS for two consecutive weeks (twice a day) during the continued treatment phase, and a maintenance intervention (twice a week for 3 months), during the rTMS follow-up phase. Following this phase, participants will be followed for further 3 months, during which no rTMS will be delivered but clinical data will be collected.
Procedure: The project consists of: Screening Visit (baseline), Phase 1 (continued treatment phase), Phase 2 (3 months- rTMS follow-up), Phase 3 (3 months follow-up without rTMS). First, there will be a screening visit, where a clinical interview will be conducted and questionnaires and tests will be administered to identify study participants who meet the inclusion and exclusion criteria. Baseline clinical and cognitive data will be acquired. In Phase 1, participants will receive 2 sessions of rTMS (active), twice per day for 10 consecutive days, for a total of 20 rTMS sessions. Following this, the investigators will evaluate the acute effect of treatment on relapse rate, gambling severity and craving, mood and cognition. In Phase 2 of the study, all participants will continue the treatment arm with rTMS (15Hz) for three months. Participants will receive 2 sessions of rTMS (active) once per week; clinical and cognitive data will be acquired once per month. The investigators will evaluate the acute effect of treatment on relapse rate, gambling severity and craving, mood and cognition. In Phase 3 of the study, participants will not receive any rTMS session. Clinical and cognitive data will be acquired once per month for three months. The investigators will evaluate the long-term effect of treatment on relapse rate, gambling severity and craving, mood and cognition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-randomized, open label study
| Arm | Type | Receives |
|---|---|---|
| Active rTMS (15 Hz) | Experimental | Device: Repetitive Transcranial Magnetic StimulationThe intervention will be Repetitive Transcranial Magnetic Stimulation. Each patient will receive active stimulation targeting the left dorsolateral prefrontal cortex (lDLPFC) with a frequency of 15 Hz and 100% of the individual resting motor threshold, for a total of 40 trains (60 stimuli per train, inter-train interval of 15 second, total duration 13 minutes). Each session will be repeated twice/daily for 10 consecutive days for 2 weeks, during the continued treatment phase. Following this, the participants will receive the maintenance intervention of 2 sessions per week for 3 months (rTMS follow-up), at the same parameters described above. Device: MagPro R30 with the Cool-B80 figure-of-eight coil (MagVenture, Falun, Denmark). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 - 65;
- Current diagnosis of Gambling Disorder, based on the Diagnostic and Statistical Manual of Mental Disorder - Fifth Edition (DSM-5);
- Drug-free.
Key exclusion criteria (7 listed)
- Current DSM-V diagnosis of substance use disorders other than nicotine dependence;
- Current DSM-V diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder;
- Use in the past 4 weeks of any medication with known pro-convulsant action; or current regular use of any psychotropic medications (benzodiazepines, antipsychotic medications, tricyclic antidepressants, anti-epileptics, mood stabilizers);
- Any history of any clinically significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes;
- Any personal or family history (1st degree relatives) of seizures other than febrile childhood seizures;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationAlso: rTMSRepetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation technique. The investigators will use a MagPro R30 with the Cool-B80 figure-of-eight coil (MagVenture, Falun, Denmark). | Device | Active rTMS (15 Hz) |
Primary outcome
Changes in the Visual Analogue Scale for Craving (VAS-craving)
Time frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months
A Visual Analogue Scale (VAS) is an instrument to measure a characteristic or attitude that is believed to range across a continuum of values. The VAS is a horizontal line, 100 mm in length, anchored by word descriptors at each end (0 = lower scores; 10 = higher scores). The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left-hand end of the line to the point that the patient marks.
Changes in the Pathological Gambling Adaptation of the Yale-Brown Obsessive-Compulsive Scale (PG-YBOCS)
Time frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months
The Pathological Gambling Adaptation of the Yale-Brown Obsessive-Compulsive Scale (PG-YBOCS) is a 10-item clinician-administered questionnaire that measures the severity of PG over the past one week. Scores from 0 (min) to 4 (max) are assigned according to the severity. The first set of questions (questions 1-5) assess urges and thoughts associated with pathological gambling, whereas the last five questions assess the behavioral component of the disorder. Both single set scores and total score will be calculated.
Changes in Gambling Disorder Severity as assessed by Timeline Follow Back (TLFB)
Time frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months
Gambling behavior will be assessed using the TimeLine Follow Back (TLFB). TLFB is an interview-based assessment. Using a calendar, participants are guided through the process of recalling and reporting daily gambling behavior. TLFB provides measures of gambling episodes per week, gambling days per week, heavy gambling days per week.
Changes in Gambling Behavior as assessed by Gambling Symptom Assessment Scale (G-SAS) Total Score
Time frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months
Gambling Symptom Assessment Scale (G-SAS) is a 12-item self-rated scale designed to assess gambling symptom severity and change during treatment. Each 12-item scale has a score ranging from 0 - 4 (adjective anchors for 0 and 4 vary for each item). All items ask for an average symptom based on the past 7 days. Total score ranges from 0 (min) to 48 (max), higher scores indicate higher severity levels.
6 secondary outcomes
Changes in the Iowa Gambling Task (IGT) Performance
Time frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months
Changes in Snaith Hamilton Pleasure Scale (SHAPS) Total Score
Time frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months
Changes in Temporal experience of Pleasure Scale (TEPS) Total
Time frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months
Changes in Montgomery-Asberg Depression Scale (MADRS) Total
Time frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months]
Changes in Hamilton Rating Scale for Anxiety (HAM-A) Total
Time frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months
Changes in Profile of Mood States (POMS), Total Mood Disturbance Score
Time frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Derived from this study: PubMed 31665732Pettorruso M, Martinotti G, Montemitro C, De Risio L, Spagnolo PA, Gallimberti L, Fanella F, Bonci A, Di Giannantonio M; Brainswitch Study Group. Multiple Sessions of High-Frequency Repetitive Transcranial Magnetic Stimulation as a Potential Treatment for Gambling Addiction: A 3-Month, Feasibility Study. Eur Addict Res. 2020;26(1):52-56. doi: 10.1159/000504169. Epub 2019 Oct 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo di Giannantonio, MD principal investigator
Department of Neuroscience, Imaging and Clinical Sciences (ITAB) - University G. d'Annunzio - Chieti (Italy)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Gambling Disorder, run by ITAB - Institute for Advanced Biomedical Technologies at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Martinotti, MD, PhD (0039 0871 3556914, giovanni.martinotti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Visual Analogue Scale for Craving (VAS-craving) (time frame: Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03336879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.