Accelerated rTMS in Gambling Disorder: a Multicentric, Randomized, Sham-controlled Trial

NCT05016479 | Not Yet Recruiting

• 1 other identifier: richt1ie1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Gambling disorder (GD), is a behavioral addiction based on keeping play despite medical, economic and social consequences. GD is characterized by progressive and persistent brain circuits alterations (reward, stress, memory, impulse control and cognitive functions), so a possible treatment could be based on neuromodulation of specific brain areas. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation, which provides magnetic stimuli on certain brain areas parts with short and long-term effects. rTMS has the FDA approval for some neurological (headache) and psychiatric (treatment-resistant depression, obsessive-compulsive disorder) disease. Nowadays several evidence in scientific literature lead to a promise use of rTMS also in addiction field with a possible indication also for GD. Objectives: the main outcome is to assess symptoms related to GD (craving, play frequencies, money lost) before and after rTMS stimulation on left dorsolateral prefrontal cortex (DLPFC). Eligibility: Healthy, right-handed adults ages 18-65 with a diagnosis of GD. Design: This is a randomized, sham-controlled study. The study includes two phases:1) a rTMS continued treatment phase and 2) a follow-up without rTMS stimulation (30 days). In order to be enrolled, participants will be screened with:

• Questionnaires
• Medical history
• Physical exam
• f-MRI After being enrolled, baseline behavioral and imaging data will be collected. In particular, participants will submit:
• Questionnaires
• Functional MRI
• Cognitive tasks During the continued rTMS phase, participants with gambling disorder will be randomized to receive real or sham rTMS. RTMS will be delivered during 5 outpatient treatment days, (3 times/die). After the last stimulation and at the end of the 30-days of follow-up period, subjects will undergo the neurocognitive and psychometric evaluation. Twenty randomized patients of whole enrolled group will undergo fMRI at baseline and at the end of arTMS treatment phase. Treatment includes:
• rTMS: A weak electrical current passes through a coil placed on the head. During each stimulation day, participants will receive three rTMS sessions (13 min), with a 50 min of interval.
• fMRI: Participants lie on a table that slides into a cylinder that takes pictures of the brain. They respond to images while in the scanner.
• Repeat of screening tests and questionnaires

Conditions

Gambling; Gambling Disorder; Gambling, Pathological; Gambling Problem

Keywords

arTMS; Transcranial Magnetic Stimulation; TMS; Gambling Disorder

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (21)

• Change in attention / hyperactivity symptoms assessed by Adult ADHD Self-Report Scale (ASRS)

  Baseline, after rTMS treatment (5 day), 4 weeks

• Change in emotional awareness assessed by Toronto Alexithymia Scale (TAS-20)

  Baseline, after rTMS treatment (5 day), 4 weeks

• Change in mood state assessed by Profile of Mood States (POMS)

  Baseline, after rTMS treatment (5 day), 4 weeks

• Change in search for sensations assessed by Sensation Seeking Scale V (SSS-V)

  Baseline, after rTMS treatment (5 day), 4 weeks

• Change in hedonic tone assessed by Snaith-Hamilton Pleasure Scale (SHAPS)

  Baseline, after rTMS treatment (5 day), 4 weeks

Study Arms (2)

Active arTMS (15 Hz)

EXPERIMENTAL

The treatment involves 15 Repetitive Transcranial Magnetic Stimlation sessions (3/daily for 5 consecutive days, each session lasts 13 min with an interval of 50 min). Coil is placed on the left dorsolateral prefrontal cortex (LDLPFC).The stimulation has a frequency of 15 Hz and a intensity of 120% of the individual resting motor threshold.

Device: Accelerated repetitive Transcranial Magnetic Stimulation

Sham arTMS

SHAM COMPARATOR

Sham group receives the same Repetitive Transcranial Magnetic Stimlation sessions of active compactors. However the interventions in the place group are with a superficial stimulation of scalp muscles only, in order to induce a sensation close to the one experienced with the real rTMS stimulation.

Device: Accelerated repetitive Transcranial Magnetic Stimulation

Interventions

Accelerated repetitive Transcranial Magnetic Stimulation DEVICE

arTMS is a non-invasive brain stimulation technique. It will be used a MagPro R30 with a Cool-B80 figure-of-eight coil (MagVenture, Falun, Denmark).

Also known as: arTMS

Active arTMS (15 Hz); Sham arTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current diagnosis of Gambling Disorder, based on the Diagnostic and Statistical Manual of Mental Disorder - Fifth Edition (DSM-5);

You may not qualify if:

• Current or pre-existing DSM-5 diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder;
• Use in the past 4 weeks of any medication with known pro-convulsant action, including antipsychotic medications, tricyclic antidepressants, and antihistamines drugs;
• Medical history with significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions and 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, according to 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.

Sponsors & Collaborators

• ITAB - Institute for Advanced Biomedical Technologies: lead

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Study Officials

• Massimo di Giannantonio, MD

  ITAB - Institute for Advanced Biomedical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauro Pettorruso, MD, PhD

CONTACT

+39 0871 355 6901; mauro.pettorruso@unich.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: With regard to the treatment, to ensure that both participants and investigators are blind to the condition (active or sham), the selection of the operation mode (15 Hz, sham) will be pre-programmed by member of the that will not be involved in data collection and analysis. Study personnel will not know which mode is being activated. Sham stimulation will use the same coil placement as that used for active stimulation. Outcomes Assessors will not be present during the rTMS sessions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: double blind, randomized, sham-controlled with a 1:1 allocation into 2 parallel arms

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 23, 2021
• Study Start: December 1, 2021
• Primary Completion: November 30, 2025
• Study Completion: February 28, 2026
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share