Alcohol WithdrawalSTIM-ALCNCT04997330
Evaluation of Bilateral HF-rTMS on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction
A study testing Active rTMS in people with Alcohol Withdrawal, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcohol Withdrawal
- What is being tested?
- Active rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2021to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-75 years
- Alcohol use disorder according to DSM 5, moderate to mild according to ADS
- Residential stay for alcohol detoxofication
Who cannot join
- Cognitive deficits defined by MoCA <25 (Montreal Cognitive Assessment) performed at least 7days after alcohol detoxification and after at least 12 hours after benzodiazepine cessation
- History of cerebral stroke
- DSM-5 substance use disorders other than nicotine and alcohol
- Contraindication for rTMS :
- Pregnancy
- History of epilepsy or seizure
Show all 22Show fewer
- Cochlear implants
- Cardiac pacemaker or intracardiac lines, or metal in the body
- Clinical history of complicated withdrawal symptoms
- History of severe head trauma followed by loss of consciousness
- Actual major depressive episode, schizophrenia according to the MINI (Mini International Neuropsychiatric Interview)
- Breastfeeding women
- Actual or history of organic failure including cirrhosis
- Absence of health insurance; or patient with AME
- Legal protection (curatorship or tutorship)
- Deprive of freedom or security measure
- No adequate mastering of the French language or no ability to consent
- Major socio-economic problem: homelessness
- No written informed consent
- Participation in another interventional study
- Secondary inclusion criteria (before randomization):
- Abnormal executive function defined as at least 3 impaired measurements among 19 measurements of 7 tests (Stroop test, Wisconsin test; Trail making test, verbal fluency, 6 elements, Brixton test, Dual task Baddeley test) from the Greffex battery. Each measure will be considered as impaired if it is below 1.65 SD. The procedure and the measurement are standardized. The neuropsychological evaluation will be performed at least seven days after alcohol detoxification and after at least 12 hours after benzodiazepine cessation.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Universitaire Pitié-Salpêtrière
Paris, 75013
Anne Radenne, 01 42 16 16 99, anne.radenne@aphp.fr
About this study
Official title: Evaluation of Bilateral HF-rTMS Over DLPFC in add-on to Usual Treatment on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction After Withdrawal
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.
Read the detailed description
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.
- Conditions
- Alcohol Withdrawal
- Being tested
- Active rTMS, Sham rTMS
- Keywords
- alcool, rTMS, executive, dysfunction, addiction
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMSDevice
Also called Experimental group
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.
Sham rTMSDevice
Also called Control 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.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Experimental | Bilateral high frequency (20Hz) Repetitive Transcranial Magnetic Stimulation (rTMS) over DLPFC Receives: Device: Active rTMS |
| Sham rTMS | Placebo comparator | Sham bilateral high frequency (20Hz) Repetitive Transcranial Magnetic Stimulation (rTMS) over DLPFC Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after the end of rTMS sessions
Secondary outcomes (28)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%).
Measured: At the end of rTMS treatment
Percentage of rTMS sessions performed.
Treatment compliance will be assessed by the percentage of rTMS sessions performed.
Measured: 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.
Measured: 3 months at the end of rTMS treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol WithdrawalStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanny LEVY, Docteur, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997330
- Sponsor's protocol ID
- APHP180582
- Other IDs
- 2020-A00548-31
- Acronym
- STIM-ALC
- Status last verified
- Mar 2021
- First submitted
- 31 Jul 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bilateral HF-rTMS Over DLPFC in add-on to Usual Treatment on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction After Withdrawal
- ClinicalTrials.gov ID
- NCT04997330
- Acronym / sponsor ID
- STIM-ALC / APHP180582
- Conditions
- Alcohol Withdrawal
- Keywords
- alcool, rTMS, executive, dysfunction, addiction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Experimental | Device: Active rTMSBilateral high frequency (20Hz) Repetitive Transcranial Magnetic Stimulation (rTMS) over DLPFC |
| Sham rTMS | Placebo comparator | Device: Sham rTMSSham bilateral high frequency (20Hz) Repetitive Transcranial Magnetic Stimulation (rTMS) over DLPFC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18-75 years
- Alcohol use disorder according to DSM 5, moderate to mild according to ADS
- Residential stay for alcohol detoxofication
Key exclusion criteria (22 listed)
- Cognitive deficits defined by MoCA <25 (Montreal Cognitive Assessment) performed at least 7days after alcohol detoxification and after at least 12 hours after benzodiazepine cessation
- History of cerebral stroke
- DSM-5 substance use disorders other than nicotine and alcohol
- Contraindication for rTMS :
- Clinical history of complicated withdrawal symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active rTMSAlso: Experimental groupBilateral 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. | Device | Active rTMS |
| Sham rTMSAlso: Control groupSham 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. | Device | Sham rTMS |
Primary outcome
Percentage of participants with continuous complete alcohol abstinence
Time frame: 1 month after the end of rTMS sessions
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.
28 secondary outcomes
Percentage of participants with alcohol continuous complete abstinence
Time frame: 3 months after the end of rTMS sessions
Number of cumulative abstinence days
Time frame: 1 month after the end of rTMS sessions
Number of cumulative abstinence days
Time frame: 3 months after the end of rTMS sessions
Time until the first heavy drinking days (HDD)
Time frame: 3 months after the end of rTMS sessions
Number of heavy drinking days (HDD)
Time frame: 1 month after the end of rTMS sessions
Number of heavy drinking days (HDD)
Time frame: 3 month after the end of rTMS sessions
Time to relapse
Time frame: 3 months after the end of rTMS sessions
Alcohol dependence severity assessed by the Alcohol Dependence Scale (ADS)
Time frame: 1 month after the end of rTMS sessions
Alcohol dependence severity assessed by the Alcohol Dependence Scale (ADS)
Time frame: 3 months after the end of rTMS sessions
Alcohol cue induced craving using the Cue induced Obsessive Compulsive Drinking Scale (OCDS)
Time frame: At the last day of rTMS sessions
Alcohol cue induced craving using the Cue induced Obsessive Compulsive Drinking Scale (OCDS)
Time frame: at 1 month after the end of rTMS sessions
Alcohol cue induced craving using the Cue induced Obsessive Compulsive Drinking Scale (OCDS)
Time frame: at 3 months after the end of rTMS sessions
Change in Alcohol cue induced craving using a Visual Analogic Scale (VAS)
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)
Time frame: At 1 month after the end of rTMS sessions
Alcohol due induced craving using a Visual Analogic Scale (VAS)
Time frame: At 3 months after the end of rTMS sessions
Number of impaired measures on the Grefex batery (executive functions)
Time frame: 1 month after the end of rTMS sessions
Stroop test
Time frame: 1 month after the end of rTMS sessions
Trail making test
Time frame: 1 month after the end of rTMS sessions
Verbal fluency
Time frame: 1 month after the end of rTMS sessions
Wisconsin Test
Time frame: 1 month after the end of rTMS sessions
Brixton test
Time frame: 1 month after the end of rTMS sessions
6 elements
Time frame: 1 month after the end of rTMS sessions
Dual task Baddeley test
Time frame: 1 month after the end of rTMS sessions
Quality of life assessed by the Quality of life Scale (AQoLS)
Time frame: At 1 month after the end of rTMS sessions
Quality of life assessed by the Quality of life Scale (AQoLS)
Time frame: At 3 months after the end of rTMS sessions
% rTMS stimulation performed with optimal stimulation parameters
Time frame: At the end of rTMS treatment
Percentage of rTMS sessions performed.
Time frame: At the end of rTMS treatment
Percentage of participants experiencing sides effect
Time frame: 3 months at the end of rTMS treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fanny LEVY, Docteur principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS in people with Alcohol Withdrawal, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fanny LEVY, Docteur (01.42.16.28.94, fanny.levy@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with continuous complete alcohol abstinence (time frame: 1 month after the end of rTMS sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.