Ignite Creation Date:
2024-05-06 @ 4:31 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05016479
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-10-26
First Post:
2021-08-17
Brief Title:
Accelerated rTMS in Gambling Disorder a Multicentric Randomized Sham-controlled Trial
Sponsor:
ITAB - Institute for Advanced Biomedical Technologies
Organization:
ITAB - Institute for Advanced Biomedical Technologies
Study Overview
Official Title:
Accelerated rTMS in Gambling Disorder a Multicentric Randomized Sham-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-10
Last Known Status:
None
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:
arTMSinGD
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 phases1 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 timesdie 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
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 phases1 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 timesdie 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
Detailed Description:
Repetitive Transcranial Magnetic Stimulation rTMS is a neurostimulation technique that consists in the application of magnetic pulses in order to modulate local brain activity opened up the possibility of interacting with dysfunctional brain circuits selectively targeting gambling-related cognitive dysfunction
The main outcome of the present study is to evaluate in a population of GD patients the effects of accelerated rTMS arTMS applied on Left Dorsolateral Prefrontal Cortex LDLPFC in terms of variations in gambling-related symptoms
In order to investigate the possible effects of arTMS on brain connectivity a subsample of patients will undergo a functional neuroimaging study based on fMRI
The study includes 3 psychiatric assessments with psychometric testing V1 enrollment V2 day 5 V3 week 4 follow-up
At Visit 1 enrollment the researcher will fully inform the patient about the study obtaining the patients informed consent to participate in the study and will determine the patients eligibility Patients will also undergo a battery of cognitive tasks and psychometric evaluation The same neurocognitive and psychiatric assessment will be repeated during Visit 2 day 5 and Visit 3 4 Weeks
The analysis of the neuroimaging data will allow to evaluate the effect of the active arTMS on brain connectivity reward system attention and executive control networks investigate the association between these evidence and clinical variables
The main outcome of the present study is to evaluate in a population of GD patients the effects of accelerated rTMS arTMS applied on Left Dorsolateral Prefrontal Cortex LDLPFC in terms of variations in gambling-related symptoms
In order to investigate the possible effects of arTMS on brain connectivity a subsample of patients will undergo a functional neuroimaging study based on fMRI
The study includes 3 psychiatric assessments with psychometric testing V1 enrollment V2 day 5 V3 week 4 follow-up
At Visit 1 enrollment the researcher will fully inform the patient about the study obtaining the patients informed consent to participate in the study and will determine the patients eligibility Patients will also undergo a battery of cognitive tasks and psychometric evaluation The same neurocognitive and psychiatric assessment will be repeated during Visit 2 day 5 and Visit 3 4 Weeks
The analysis of the neuroimaging data will allow to evaluate the effect of the active arTMS on brain connectivity reward system attention and executive control networks investigate the association between these evidence and clinical variables
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?:
None
Is an FDA AA801 Violation?:
None