Ignite Creation Date:
2024-05-06 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03336879
Status:
UNKNOWN
Last Update Posted:
2017-11-08
First Post:
2017-11-06
Brief Title:
Repetitive Transcranial Magnetic Stimulation in Gambling Disorder
Sponsor:
ITAB - Institute for Advanced Biomedical Technologies
Organization:
ITAB - Institute for Advanced Biomedical Technologies
Study Overview
Official Title:
Exploring the Potential of High-frequency Repetitive Transcranial Magnetic Stimulation rTMS to Treat Gambling Disorder GD
Status:
UNKNOWN
Status Verified Date:
2017-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 daysweek Following this phase subjects will have 12 follow-up visits onceweekly 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
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 daysweek Following this phase subjects will have 12 follow-up visits onceweekly 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None