NCT03733808

Brief Summary

Gambling disorder (GD), currently considered a behavioral addiction, show substantial similarities with substance use disorders (SUDs) in terms of neurobiology and symptomatology. In particular, alterations in prefrontal control circuit may underlie vulnerability to gambling- and drug-related cues and diminished cognitive control over craving, and negative emotions. Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (DLPFC) could represent a novel approach to remodel these brain circuits. The aim of this study is to evaluate High frequency (HF) rTMS over the left DLPFC as an efficacious treatment for reduction of gambling urges and behavior in a randomized double-blind placebo-controlled design in which 36 GD patients will receive active or sham rTMS for 12 weeks.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 11, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

2.6 years

First QC Date

November 6, 2018

Last Update Submit

February 4, 2020

Conditions

Gambling Disorder

Keywords

rTMS

Outcome Measures

Primary Outcomes (1)

  • High frequency rTMS effects on changes of the gambling symptoms severity

    The main outcome will be defined as the difference in the variation between baseline and after treatment day 30 of the severity of gambling symptoms assessed through the G-SAS (Gambling Symptom Assessment Scale). Range from: 0-48 (higher values=worse symptoms)

    Baseline- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)- after 1 month follow-up- after 2 months follow-up- after 3 months follow-up

Secondary Outcomes (4)

  • High frequency rTMS effects on prefrontal hemodynamics activity in response to cue reactivity tasks

    Baseline- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)- after 1 month follow-up- after 2 months follow-up- after 3 months follow-up

  • High frequency rTMS effects on the propensity for future reinforcers to maintain current responding

    Baseline- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)- after 1 month follow-up- after 2 months follow-up- after 3 months follow-up

  • High frequency rTMS effects on changes in decision-making ability linked to emotional and activation self-regulation functions

    Baseline- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)- after 1 month follow-up- after 2 months follow-up- after 3 months follow-up

  • High frequency rTMS effects on resting functional connectivity

    Baseline- Day 90 (after 32 rTMS sessions)

Study Arms (2)

Active rTMS treatment

ACTIVE COMPARATOR

Active High frequency rTMS will be administered with a Magventure MagPro Stimulator R30 using a butterfly coil. The stimulation protocol parameters will be set as follow: frequency of 15 Hz, of 100% of resting motor threshold (rMT), 40 trains, 60 pulses per train, 15 s intertrain-interval, 2400 pulses per session.

Device: Repetitive Transcranial Magnetic Stimulation

Sham rTMS treatment

SHAM COMPARATOR

Sham rTMS will be administered with a Magventure MagPro Stimulator R30 using a butterfly sham coil. The same procedures of active High frequency rTMS will be used.

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

Non-invasive brain stimulation technique

Active rTMS treatmentSham rTMS treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65;
  • Current DSM-5 diagnosis of Gambling Disorder;
  • Right-handed;

You may not qualify if:

  • Current DSM-5 diagnosis of Schizophrenia Spectrum and other Psychotic Disorders;
  • Current DSM-5 diagnosis of Bipolar and related Disorders;
  • 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 history of seizures other than febrile childhood seizures;
  • Presence of iron magnetic objects in the body contraindicated for treatments with rTMS and for participation in MRI sessions (pacemakers or other electrical devices implants, brain stimulators, some types of dental implants, aneurysm clips, metal implants, permanent eyeliner, fragments of projectile);
  • Inability to remain lying on the back for up to 2 hours in the MRI plant;
  • Current DSM-5 diagnosis of any Substance Use disorder with the exception of Tobacco Use Disorder and Mild Alcohol Use Disorder;
  • Positive drug urine test to one or more classes of substances of abuse;
  • For female subjects: pregnancy or breastfeeding in progress;
  • Judicial provision that includes a cure in progress or if the subject is already engaged in a cure for gambling disorder;
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Casa di Cura Park Villa Napoleon

Preganziol, Treviso, 31022, Italy

RECRUITING

MeSH Terms

Conditions

Gambling

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Franco Garonna, MD

    Casa di Cura Park Villa Napoleon

    PRINCIPAL INVESTIGATOR

  • Stefano Cardullo, PhD

    Fondazione Novella Fronda

    STUDY CHAIR

Central Study Contacts

Graziella Madeo, MD, PhD

CONTACT

0039 3920170804graziemadeo@gmail.com

Luis J Gómez Pérez, MSc

CONTACT

0039 3286086304luigomper@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double blind, randomized, sham-controlled with a 1:1 allocation into 2 parallel arms
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 7, 2018

Study Start

December 11, 2018

Primary Completion

August 1, 2021

Study Completion

August 1, 2022

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

IT(1)