Evaluation of Bilateral HF-rTMS on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction
NCT04997330, Not applicable, Unknown, Assistance Publique - Hôpitaux de Paris
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Evaluation of Bilateral HF-rTMS on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction | ClinicalTrials.gov |
| NCT number | NCT04997330 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 95 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris | ClinicalTrials.gov |
| Conditions | Alcohol Withdrawal | ClinicalTrials.gov |
| Interventions | Active rTMS, Sham rTMS | ClinicalTrials.gov |
| First posted | 2021-08-09 | ClinicalTrials.gov |
| Last updated | 2021-08-30 | ClinicalTrials.gov |
Registered outcomes 29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Percentage of participants with continuous complete alcohol abstinence | 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. | ClinicalTrials.gov |
| Secondary | Percentage of participants with alcohol continuous complete abstinence | 3 months after the end of rTMS sessions | 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. | ClinicalTrials.gov |
| Secondary | Number of cumulative abstinence days | 1 month after the end of rTMS sessions | 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. | ClinicalTrials.gov |
| Secondary | Number of cumulative abstinence days | 3 months after the end of rTMS sessions | 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. | ClinicalTrials.gov |
| Secondary | Time until the first heavy drinking days (HDD) | 3 months after the end of rTMS sessions | 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. | ClinicalTrials.gov |
| Secondary | Number of heavy drinking days (HDD) | 1 month after the end of rTMS sessions | 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. | ClinicalTrials.gov |
| Secondary | Number of heavy drinking days (HDD) | 3 month after the end of rTMS sessions | 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. | ClinicalTrials.gov |
| Secondary | Time to relapse | 3 months after the end of rTMS sessions | 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. | ClinicalTrials.gov |
| Secondary | Alcohol dependence severity assessed by the Alcohol Dependence Scale (ADS) | 1 month after the end of rTMS sessions | 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. | ClinicalTrials.gov |
| Secondary | Alcohol dependence severity assessed by the Alcohol Dependence Scale (ADS) | 3 months after the end of rTMS sessions | 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. | ClinicalTrials.gov |
| Secondary | Alcohol cue induced craving using the Cue induced Obsessive Compulsive Drinking Scale (OCDS) | At the last day of rTMS sessions | 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. | ClinicalTrials.gov |
| Secondary | Alcohol cue induced craving using the Cue induced Obsessive Compulsive Drinking Scale (OCDS) | at 1 month after the end of rTMS sessions | 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. | ClinicalTrials.gov |
| Secondary | Alcohol cue induced craving using the Cue induced Obsessive Compulsive Drinking Scale (OCDS) | at 3 months after the end of rTMS sessions | 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. | ClinicalTrials.gov |
| Secondary | Change in Alcohol cue induced craving using a Visual Analogic Scale (VAS) | From baseline to the last rTMS session after the end of rTMS sessions | 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. | ClinicalTrials.gov |
| Secondary | Alcohol cue induced craving using a Visual Analogic Scale (VAS) | At 1 month after the end of rTMS sessions | The VAS is scored out of 10, higher scores are considered worse. Alcohol cues will be the same as for OCDS. | ClinicalTrials.gov |
| Secondary | Alcohol due induced craving using a Visual Analogic Scale (VAS) | At 3 months after the end of rTMS sessions | The VAS is scored out of 10, higher scores are considered worse. Alcohol cues will be the same as for OCDS. | ClinicalTrials.gov |
| Secondary | Number of impaired measures on the Grefex batery (executive functions) | 1 month after the end of rTMS sessions | 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. | ClinicalTrials.gov |
| Secondary | Stroop test | 1 month after the end of rTMS sessions | 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. | ClinicalTrials.gov |
| Secondary | Trail making test | 1 month after the end of rTMS sessions | 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. | ClinicalTrials.gov |
| Secondary | Verbal fluency | 1 month after the end of rTMS sessions | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Rule Anticipation Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)