An interventional study of Active rTMS and Sham rTMS in Alcohol Withdrawal, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-30.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
High frequency repetitive transcranial magnetic stimulation (HF-rTMS) over dorsolateral prefrontal cortex (DLPFC) could correct defective executive functions over the hyperactive reward circuit through the meso-fronto-limbic connections. The restored cortical inhibitory control over compulsive alcohol use, could improve abstinence after withdrawal. The goal of this study is to evaluate the efficacy of HF-rTMS over DLPFC in AUD patients with executive dysfunction after withdrawal.
PARTICIPANTS:
Participants with AUD (moderate to mild according to Alcohol Dependance Scale) with executive dysfunctions will be randomized.
DESIGN:
This study is a multicenter pilot double blind randomized controlled trial. After at least seven days of alcohol residential detoxification, executive dysfunctions's participants will be tested. 64 of them with executive dysfunctions will be randomized either in the active rTMS group or in the sham rTMS group. TMS will be performed during hospitalisation over 10 days. rTMS are proposed as an add on to the usual treatment.
INTERVENTION:
20 rTMS (twice a day) will be performed 10 consecutive working days. The target of the rTMS will be the DLPFC (left side in the morning, right side in the afternoon). During each rTMS sessions (active and sham), alcohol related pictures from the Geneva Appetitive alcohol Pictures will be presented.In the active arm, rTMS will be performed with high frequency (20hz, 1500 pulses per session, 110% of motor threshold).In the control group, sham rTMS will be performed.
Participants will be follow up to three months after the end of rTMS treatment.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's planned enrollment of 95 is close to the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
Contraindication for rTMS :
Secondary inclusion criteria (before randomization):
Bilateral high frequency (20Hz) Repetitive Transcranial Magnetic Stimulation (rTMS) over DLPFC
Device: Active rTMS
Sham bilateral high frequency (20Hz) Repetitive Transcranial Magnetic Stimulation (rTMS) over DLPFC
Device: Sham rTMS
Bilateral high frequency (20Hz) rTMS will be delivered (over dorsolateral prefrontal cortex), at two daily sessions (left side on the morning and right side on the afternoon), 10 consecutive days on working day, 1500 pulses/session, 110% of motor threshold determined, 30 trains, 50 pulses per train and 15s inter train. A session will typically last around 10 minutes. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures will be presented during each rTMS session.
Also known as: Experimental group
Sham rTMS will be delivered (over dorsolateral prefrontal cortex) , at two daily sessions (left side on the morning and right side on the afternoon), 10 consecutive working days. A session will typically last around 10 minutes. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures will be presented during each rTMS session.
Also known as: Control group
Percentage of participants with continuous complete alcohol abstinence
Percentage of patients with continuous complete abstinence up to one month after the end of the rTMS treatment. The abstinence will be assessed using the Alcohol-Time Line Follow Back tool (TLFB). The Alcohol TLFB is a descriptive questionnaire, using a calendar, participants will retrospectively record at M1 the number of days they drank over the 30 days following the end of the rTMS treatment. Continuous complete abstinence will be defined as no day with alcohol consumption over the 30 days.
Time frame: 1 month after the end of rTMS sessions
Percentage of participants with alcohol continuous complete abstinence
Percentage of patients with continuous complete abstinence up to 3 months after the end of the rTMS treatment. The abstinence will be assessed using the Alcohol-TLFB at M1, M2, M3. Continuous complete abstinence will be defined as no day with alcohol consumption over the 90 days.
Time frame: 3 months after the end of rTMS sessions
Number of cumulative abstinence days
Alcohol consumption measured by the number of cumulative abstinence days up to 1 month after the end of the rTMS treatment. The number of cumulative abstinence days will be assessed using (TLFB) at M1 and will be calculated by summing the total number of days when no alcohol was consumed over the 30 days.
Time frame: 1 month after the end of rTMS sessions
Number of cumulative abstinence days
Alcohol consumption measured by the number of cumulative abstinence days up to 3 months after the end of the rTMS treatment. The number of cumulative abstinence days will be assessed using (TLFB) at M1, M2, M3 and will be calculated by summing the total number of days when no alcohol was consumed over the 90 days.
Time frame: 3 months after the end of rTMS sessions
Time until the first heavy drinking days (HDD)
Time until the first heavy drinking days (HDD) up to 3 months. The time, in days, until the first HDD will be assessed using (TLFB) at M1, M2, M3. HDD will be defined as more than 50 (men) or 40 (women) g/day.
Time frame: 3 months after the end of rTMS sessions
Number of heavy drinking days (HDD)
Number of heavy drinking days (HDD) up to 1 month. Number of heavy drinking days HDD will be assessed using (TLFB) at M1 and will be calculated by summing the total number of days with HDD over the 30 days. HDD will be defined as more than 50 (men) or 40 (women) g/day.
Time frame: 1 month after the end of rTMS sessions
Number of heavy drinking days (HDD)
Number of heavy drinking days (HDD) up to 3 months. Number of heavy drinking days HDD will be assessed using (TLFB) at M1, M2, M3 and will be calculated by summing the total number of days with HDD over the 90 days.. HDD will be defined as more than 50 (men) or 40 (women) g/day.
Time frame: 3 month after the end of rTMS sessions
Time to relapse
The time to relapse, in days, will be assessed using (TLFB) at M1, M2, M3. Relapse will be defined as a day with a consumption equal or higher than 50% of initial intake.
Time frame: 3 months after the end of rTMS sessions
Alcohol dependence severity assessed by the Alcohol Dependence Scale (ADS)
Alcohol dependence severity will be evaluated with the Alcohol Dependence Scale (ADS). The ADS is a self-administrated 25-items questionnaire (requiring 5 minutes) assessing alcohol withdrawal symptoms, impaired control over drinking, awareness of compulsive drink, increased tolerance and salience of drink-seeking behavior. ADS is initially used to assess a past 12-month period, its instructions can be modified for different time-frame. The ADS will be assessed on previous 4 weeks. This scale is scored out of 47, higher scores are considered worse.
Time frame: 1 month after the end of rTMS sessions
Alcohol dependence severity assessed by the Alcohol Dependence Scale (ADS)
Alcohol dependence severity will be evaluated with the Alcohol Dependence Scale (ADS). The ADS is a self-administrated 25-items questionnaire (requiring 5 minutes) assessing alcohol withdrawal symptoms, impaired control over drinking, awareness of compulsive drink, increased tolerance and salience of drink-seeking behavior. ADS is initially used to assess a past 12-month period, its instructions can be modified for different time-frame. The ADS will be assessed on previous 4 weeks. This scale is scored out of 47, higher scores are considered worse.
Time frame: 3 months after the end of rTMS sessions
Alcohol cue induced craving using the Cue induced Obsessive Compulsive Drinking Scale (OCDS)
Evaluated by Cue induced Obsessive Compulsive Drinking Scale (OCDS). Cue induced OCDS will be measured after alcohol cues viewing. French version of OCDS is a self-administrated 14-items instrument assessing obsessive and compulsive characteristics of drinking-related thoughts, urge to drink or craving, and ability to resist those thoughts and urges. This scale is scored out of 56, higher scores are considered worse. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures . The same diaporama will be used for all visits in all centers.
Time frame: At the last day of rTMS sessions
Alcohol cue induced craving using the Cue induced Obsessive Compulsive Drinking Scale (OCDS)
Evaluated by Cue induced Obsessive Compulsive Drinking Scale (OCDS). Cue induced OCDS will be measured after alcohol cues viewing. French version of OCDS is a self-administrated 14-items instrument assessing obsessive and compulsive characteristics of drinking-related thoughts, urge to drink or craving, and ability to resist those thoughts and urges. This scale is scored out of 56, higher scores are considered worse. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures . The same diaporama will be used for all visits in all centers.
Time frame: at 1 month after the end of rTMS sessions
Alcohol cue induced craving using the Cue induced Obsessive Compulsive Drinking Scale (OCDS)
Evaluated by Cue induced Obsessive Compulsive Drinking Scale (OCDS). Cue induced OCDS will be measured after alcohol cues viewing. French version of OCDS is a self-administrated 14-items instrument assessing obsessive and compulsive characteristics of drinking-related thoughts, urge to drink or craving, and ability to resist those thoughts and urges. This scale is scored out of 56, higher scores are considered worse. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures . The same diaporama will be used for all visits in all centers.
Time frame: at 3 months after the end of rTMS sessions
Change in Alcohol cue induced craving using a Visual Analogic Scale (VAS)
Change in cue induced craving Visual Analogic Scale (VAS) from baseline to the last rTMS session. Cue induced craving VAS will be measured after alcohol cues viewing at baseline and then daily on the morning just before rTMS sessions. The VAS is scored out of 10, higher scores are considered worse. Alcohol cues will be the same as for OCDS.
Time frame: From baseline to the last rTMS session after the end of rTMS sessions
Alcohol cue induced craving using a Visual Analogic Scale (VAS)
The VAS is scored out of 10, higher scores are considered worse. Alcohol cues will be the same as for OCDS.
Time frame: At 1 month after the end of rTMS sessions
Alcohol due induced craving using a Visual Analogic Scale (VAS)
The VAS is scored out of 10, higher scores are considered worse. Alcohol cues will be the same as for OCDS.
Time frame: At 3 months after the end of rTMS sessions
Number of impaired measures on the Grefex batery (executive functions)
Executive performance will be evaluated by the number of impaired measures on the Grefex battery : Stroop test, Wisconsin Test, Trail Making Test, verbal fluency, 6 elements, Brixton test and Dual task Baddeley test. Upon these 7 tests, 19 index will be measured (number of errors, time to make the task .). Each measure will be considered as impaired if it is below 1.65 SD. Number of impaired measures will be recorded for each patient.
Time frame: 1 month after the end of rTMS sessions
Stroop test
Stroop test will be performed 1 month after the end of the rTMS sessions. The stroop test assess the cognitive inhibition. Time and number of non-corrected errors will be reported for each conditions 1) denomination 2) reading 3) interference.
Time frame: 1 month after the end of rTMS sessions
Trail making test
Trail making test will be performed 1 month after the end of the rTMS sessions. The trail making test assess the mental flexibility. Time and number of errors will be reported for the trail making test A and the trail making test B. For this last condition, the number of perserverations will be also reported.
Time frame: 1 month after the end of rTMS sessions
Verbal fluency
Verbal fluency will be performed 1 month after the ned of the rTMS sessions. The verbal fluency assess the lexical generation ability. The number of words produced will be reported.
Time frame: 1 month after the end of rTMS sessions
Wisconsin Test
Wisconsin test will be performed 1 month after the ned of the rTMS sessions. The Wisconsin test assess the ability of deduction and rules maintenance. Number of correct categories, number of errors and number of perseverations will be reported.
Time frame: 1 month after the end of rTMS sessions
Brixton test
Brixton test test will be performed 1 month after the ned of the rTMS sessions. The Brixton test assess the deduction abilify of working rules. Number of errors will be reported.
Time frame: 1 month after the end of rTMS sessions
6 elements
6 elements test will be performed 1 month after the ned of the rTMS sessions. The 6 elements test assess the planning and organization ability of the behavior. Ranking score will be reported.
Time frame: 1 month after the end of rTMS sessions
Dual task Baddeley test
Dual task Baddeley testwill be performed 1 month after the end of the rTMS sessions. The Dual task Baddeley assess the working memory. Mu index will be reported.
Time frame: 1 month after the end of rTMS sessions
Quality of life assessed by the Quality of life Scale (AQoLS)
Quality of life will be evaluated with Alcohol Quality of Life Scale (AQoLS) French version. This scale is a self-administrated 34-item questionnaire measuring health-related quality of life. The questionnaire explores 7 domains, i.e. activities, relationships, self-esteem, negative emotions, living conditions, control and sleep. The total score was obtained by summing all items, and the theoretical range was therefore 0-102; higher scores are considered better.
Time frame: At 1 month after the end of rTMS sessions
Quality of life assessed by the Quality of life Scale (AQoLS)
Quality of life will be evaluated with Alcohol Quality of Life Scale (AQoLS) French version. This scale is a self-administrated 34-item questionnaire measuring health-related quality of life. The questionnaire explores 7 domains, i.e. activities, relationships, self-esteem, negative emotions, living conditions, control and sleep. The total score was obtained by summing all items, and the theoretical range was therefore 0-102; higher scores are considered better.
Time frame: At 3 months after the end of rTMS sessions
% rTMS stimulation performed with optimal stimulation parameters
Achievement of optimal stimulation parameters will be assessed for each patient by the percentage of sessions performed with the theoretical threshold (110%).
Time frame: At the end of rTMS treatment
Percentage of rTMS sessions performed.
Treatment compliance will be assessed by the percentage of rTMS sessions performed.
Time frame: At the end of rTMS treatment
Percentage of participants experiencing sides effect
rTMS security will be assessed by the percentage of patients experiencing sides effects during the study and their nature: seizure induction, transient acute hypomania induction, syncope, transient headache, local pain, neck pain, toothache, paresthesia, transient hearing changes, other.
Time frame: 3 months at the end of rTMS treatment
Plan to share: Yes — Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Supporting information: Study protocol, Sap, Icf
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