Repetitive Transcranial Magnetic Stimulation in Gambling Disorder

NCT03336879 | Unknown

• 1 other identifier: v.2_19/10/2017
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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. 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

Conditions

Gambling Disorder

Keywords

Gambling Disorder; Mental Disorder; Behavioral Addiction

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months, 12 months

Secondary Outcomes (6)

• Changes in the Iowa Gambling Task (IGT) Performance

  Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months

• Changes in Snaith Hamilton Pleasure Scale (SHAPS) Total Score

  Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months

• Changes in Temporal experience of Pleasure Scale (TEPS) Total

  Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months

• Changes in Montgomery-Asberg Depression Scale (MADRS) Total

  Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months]

• Changes in Hamilton Rating Scale for Anxiety (HAM-A) Total

  Baseline, after rTMS treatment: 2 weeks, 3 months, 6 months

Study Arms (1)

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).

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

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).

Also known as: rTMS

Active rTMS (15 Hz)

Eligibility Criteria

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

You may qualify if:

• Age 18 - 65;
• Current diagnosis of Gambling Disorder, based on the Diagnostic and Statistical Manual of Mental Disorder - Fifth Edition (DSM-5);
• Drug-free.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ITAB - Institute for Advanced Biomedical Technologies: lead

Study Sites (2)

Department of Neuroscience, Imaging and Clinical Sciences

Chieti, 66100, Italy

RECRUITING

La Promessa ONLUS

Roma, 00192, Italy

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 31665732 DERIVED

MeSH Terms

Conditions

Gambling; Mental Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Massimo di Giannantonio, MD

  Department of Neuroscience, Imaging and Clinical Sciences (ITAB) - University G. d'Annunzio - Chieti (Italy)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Martinotti, MD, PhD

CONTACT

0039 0871 3556914; giovanni.martinotti@gmail.com

Mauro Pettorruso, MD

CONTACT

0039 3391979487; mauro.pettorruso@hotmail.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: non-randomized, open label study

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 8, 2017
• Study Start: November 1, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2020
• Last Updated: November 8, 2017

Record last verified: 2017-11

Locations

IT (2)