Active tDCSNCT04990375
tDCS to Prevent Relapse in Alcohol Use Disorder
A study testing tDCS in people with Active tDCS and Sham tDCS, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Despite the system of care in place, patients suffering from an alcohol use disorder (AUD) continue to relapse after their detoxification. For about twenty years, neuromodulations and their mechanisms have been investigated in research in order to apply it as a therapeutic means, in particular direct current… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Active tDCS, Sham tDCS
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Apr 2021to 6 Jun 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- French speaker
- Severe Alcohol Use Disorder requiring alcohol rehabilitation
- Desire to stay sober for at least the next six months
Who cannot join
- Neurological history (epilepsy, head injury, and stroke)
- Mental confusion or severe cognitive impairment
- Schizophrenia, chronic psychotic disorders or bipolar type 1 disorder
- Metal in the brain
- Pregnancy
- Having participated in our previous study combining tDCS with ICT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placebo-controlled Randomized Clinical Trial: tDCS to Prevent Relapse in Alcohol Use Disorder
Despite the system of care in place, patients suffering from an alcohol use disorder (AUD) continue to relapse after their detoxification. For about twenty years, neuromodulations and their mechanisms have been investigated in research in order to apply it as a therapeutic means, in particular direct current transcranial stimulation (tDCS). A previous study found a reduction of relapse rate thanks to the tDCS over the dorsolateral prefrontal cortex (DLPFC; anode on the right and cathode on the left) combined with an ICT.
This clinical trial of 5 sessions of tDCS alone on the DLPFC (20 minutes, anode on the right, cathode on the left). This study follows the same tDCS configuration as the previous one and takes place in the same multidisciplinary detoxification framework in order to see the relevance of using combined tDCS or only tDCS in clinical practice.
Read the detailed description
Hypotheses: For patients with AUD five sessions of tDCS during a detoxification:
- decrease the relapse rate 2 weeks after the treatment;
- decrease patient craving;
- decrease depression and anxiety symptoms;
- strengthen working memory performances.
Context: This is a clinical trial that is part of an alcohol detoxification cure at Unit 72 Addictology of CHU Brugmann. The idea is to add a neuromodulation intervention to the initial management, multidisciplinary and psycho-bio-social. This will be a randomized, sham-controlled, single-blind study.
A total of 60 subjects will be recruited according to the inclusion and exclusion criteria. They will be randomly divided into two groups: the 'active' group (A) that will benefit from tDCS stimulation and the 'sham' group (S).
Measures:
Primary dependent variables :
Relapse and total abstinence measured at several defined times: two weeks, one month, three months, six months and one year after treatment.
Secondary dependent variables:
- Craving measured before and after each tDCS session via visual analog scales, such as Likert 0 to 10. Craving will also be measured in T1 and T2 through the Craving Experience Questionnaire (CEQ);
- Symptoms of depression with the Beck Depression Inventory (BDI-II) and positive and negative affectivity with the Positive and Negative Affect Schedule (PANAS) measured at T1 and T2;
- Anxiety trait in T1 and T2 with the State Anxiety Inventory (STAI-A).
- The working memory performance measured in T1 and T2 with the span reversed.
All the questionnaires were in French version.
Metacognition items: At the end of the experiment, patients will be asked orally (1) Do you think you are in the active tDCS group?, (2) Would you be interested in continuing this intervention over a longer period of time?
Statistical analyses:
Primary measurement: In order to respond to our primary assumptions about relapse, a logistic regressions will be performed with the independent variable conditions (tDCS active scored 1 and tDCS sham scored -1) and the variable dependent relapse at each measurement (2 weeks, 1 month, 3 months, 6 months and 1 year). A Kaplan-Meier survival analysis will be performed on the number of days prior to relapse to compare the curves up to one year of follow-up.
Secondary measures: In order to respond to our secondary assumptions about the variables before and after the intervention, mixed repeated measures ANOVAs [Time (T1 vs. T2) x Condition (tDCS active vs. tDCS sham)] will be performed.
- Conditions
- Active tDCS, Sham tDCS
- Being tested
- tDCS
- Keywords
- tDCS, DLPFC, Alcohol use disorder, Relapse, Craving
- Medical subject headings
- Alcoholism, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
5 sessions of 20-minute tDCS at 2 mA over the dorsolateral prefrontal cortex (35cm² sponge)
| Study group | Role | What they receive |
|---|---|---|
| Early relapse (2-week follow-up) | Sham comparator | We compare 5 sessions of active tDCS (2 mA) vs. 5 sessions of sham tDCS (0 mA) to observe if tDCS can reduce early relapse (2-week follow-up). The tDCS is applied during 20 minutes while the patient is watching a documentary about nature. For both active and sham tDCS there is 15-second ramping up and down. Receives: Device: tDCS |
| Craving | Experimental | We compare scored craving before and after 5 sessions of either active (2mA) or sham (0mA) tDCS. The tDCS is applied during 20 minutes while the patient is watching a documentary about nature. For both active and sham tDCS there is 15-second ramping up and down. Receives: Device: tDCS |
| Working memory | Experimental | We compare reverse memory span before and after 5 sessions of either active (2mA) or sham (0mA) tDCS. The tDCS is applied during 20 minutes while the patient is watching a documentary about nature. For both active and sham tDCS there is 15-second ramping up and down. Receives: Device: tDCS |
| Depressive symptoms | Experimental | We compare scored BDI-II before and after 5 sessions of either active (2mA) or sham (0mA) tDCS. The tDCS is applied during 20 minutes while the patient is watching a documentary about nature. For both active and sham tDCS there is 15-second ramping up and down. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate 2 weeks after discharge
by phone call; more than 60 g of alcohol
Measured: 2-week follow-up
Relapse rate 1 month after discharge
by phone call; more than 60 g of alcohol
Measured: 1-month follow-up
Relapse rate 3 months after discharge
by phone call; more than 60 g of alcohol
Measured: 3-month follow-up
Secondary outcomes (8)
Craving
Visual Analog Scales (4 items, range 1-9 each; 1 = no craving, 9 = extreme craving)
Measured: at pre-intervention (day 12 of hospitalization)
Craving
Visual Analog Scales (4 items, range 1-9 each; 1 = no craving, 9 = extreme craving)
Measured: at post-intervention (day 22 of hospitalization)
Working memory
Reverse memory span, range 2-9
Measured: at pre-intervention (day 12 of hospitalization)
Working memory
Reverse memory span, range 2-9
Measured: at post-intervention (day 22 of hospitalization)
Depressive symptoms
Beck Depression Inventory II (BDI-II) [44], which assessed the severity of depressive symptoms (21 items; range, 0-63; 10-18 = mild depression, 19-29 = moderate depression, 30-63 = severe depression)
Measured: at pre-intervention (day 12 of hospitalization)
Depressive symptoms
Beck Depression Inventory II (BDI-II) [44], which assessed the severity of depressive symptoms (21 items; range, 0-63; 10-18 = mild depression, 19-29 = moderate depression, 30-63 = severe depression)
Measured: at post-intervention (day 22 of hospitalization)
Anxiety state
The State-Trait Anxiety Inventory (STAI-Y) A which assessed the anxiety state (20 items; range, 20-80; < 35 = very low anxiety state, 36-45 = low anxiety state, 46-55 = medium anxiety state, 56-65 = high anxiety state, >65 = very high anxiety state).
Measured: at pre-intervention (day 12 of hospitalization)
Anxiety state
The State-Trait Anxiety Inventory (STAI-Y) A which assessed the anxiety state (20 items; range, 20-80; < 35 = very low anxiety state, 36-45 = low anxiety state, 46-55 = medium anxiety state, 56-65 = high anxiety state, >65 = very high anxiety state).
Measured: at post-intervention (day 22 of hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start2 Apr 2021
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active tDCSStudies of the same condition, open and under way.
- 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
- Model description
- active tDCS vs. sham tDCS, while the patient is watching a documentary
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Macha Dubuson, Brugmann University Hospital
- Investigators
- Dubuson Macha, MA, Principal investigator, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990375
- Sponsor's protocol ID
- tDCS in AUD
- Status last verified
- Sep 2022
- First submitted
- 13 Jul 2021
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled Randomized Clinical Trial: tDCS to Prevent Relapse in Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04990375
- Acronym / sponsor ID
- tDCS in AUD
- Conditions
- Active tDCS, Sham tDCS
- Keywords
- tDCS, DLPFC, Alcohol use disorder, Relapse, Craving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 4 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.
Despite the system of care in place, patients suffering from an alcohol use disorder (AUD) continue to relapse after their detoxification. For about twenty years, neuromodulations and their mechanisms have been investigated in research in order to apply it as a therapeutic means, in particular direct current transcranial stimulation (tDCS). A previous study found a reduction of relapse rate thanks to the tDCS over the dorsolateral prefrontal cortex (DLPFC; anode on the right and cathode on the left) combined with an ICT.
This clinical trial of 5 sessions of tDCS alone on the DLPFC (20 minutes, anode on the right, cathode on the left). This study follows the same tDCS configuration as the previous one and takes place in the same multidisciplinary detoxification framework in order to see the relevance of using combined tDCS or only tDCS in clinical practice.
Detailed description
Hypotheses: For patients with AUD five sessions of tDCS during a detoxification:
- decrease the relapse rate 2 weeks after the treatment;
- decrease patient craving;
- decrease depression and anxiety symptoms;
- strengthen working memory performances.
Context: This is a clinical trial that is part of an alcohol detoxification cure at Unit 72 Addictology of CHU Brugmann. The idea is to add a neuromodulation intervention to the initial management, multidisciplinary and psycho-bio-social. This will be a randomized, sham-controlled, single-blind study.
A total of 60 subjects will be recruited according to the inclusion and exclusion criteria. They will be randomly divided into two groups: the 'active' group (A) that will benefit from tDCS stimulation and the 'sham' group (S).
Measures:
Primary dependent variables :
Relapse and total abstinence measured at several defined times: two weeks, one month, three months, six months and one year after treatment.
Secondary dependent variables:
- Craving measured before and after each tDCS session via visual analog scales, such as Likert 0 to 10. Craving will also be measured in T1 and T2 through the Craving Experience Questionnaire (CEQ);
- Symptoms of depression with the Beck Depression Inventory (BDI-II) and positive and negative affectivity with the Positive and Negative Affect Schedule (PANAS) measured at T1 and T2;
- Anxiety trait in T1 and T2 with the State Anxiety Inventory (STAI-A).
- The working memory performance measured in T1 and T2 with the span reversed.
All the questionnaires were in French version.
Metacognition items: At the end of the experiment, patients will be asked orally (1) Do you think you are in the active tDCS group?, (2) Would you be interested in continuing this intervention over a longer period of time?
Statistical analyses:
Primary measurement: In order to respond to our primary assumptions about relapse, a logistic regressions will be performed with the independent variable conditions (tDCS active scored 1 and tDCS sham scored -1) and the variable dependent relapse at each measurement (2 weeks, 1 month, 3 months, 6 months and 1 year). A Kaplan-Meier survival analysis will be performed on the number of days prior to relapse to compare the curves up to one year of follow-up.
Secondary measures: In order to respond to our secondary assumptions about the variables before and after the intervention, mixed repeated measures ANOVAs [Time (T1 vs. T2) x Condition (tDCS active vs. tDCS sham)] will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- active tDCS vs. sham tDCS, while the patient is watching a documentary
| Arm | Type | Receives |
|---|---|---|
| Early relapse (2-week follow-up) | Sham comparator | Device: tDCSWe compare 5 sessions of active tDCS (2 mA) vs. 5 sessions of sham tDCS (0 mA) to observe if tDCS can reduce early relapse (2-week follow-up). The tDCS is applied during 20 minutes while the patient is watching a documentary about nature. For both active and sham tDCS there is 15-second ramping up and down. |
| Craving | Experimental | Device: tDCSWe compare scored craving before and after 5 sessions of either active (2mA) or sham (0mA) tDCS. The tDCS is applied during 20 minutes while the patient is watching a documentary about nature. For both active and sham tDCS there is 15-second ramping up and down. |
| Working memory | Experimental | Device: tDCSWe compare reverse memory span before and after 5 sessions of either active (2mA) or sham (0mA) tDCS. The tDCS is applied during 20 minutes while the patient is watching a documentary about nature. For both active and sham tDCS there is 15-second ramping up and down. |
| Depressive symptoms | Experimental | Device: tDCSWe compare scored BDI-II before and after 5 sessions of either active (2mA) or sham (0mA) tDCS. The tDCS is applied during 20 minutes while the patient is watching a documentary about nature. For both active and sham tDCS there is 15-second ramping up and down. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- French speaker
- Severe Alcohol Use Disorder requiring alcohol rehabilitation
- Desire to stay sober for at least the next six months
Key exclusion criteria (6 listed)
- Neurological history (epilepsy, head injury, and stroke)
- Mental confusion or severe cognitive impairment
- Schizophrenia, chronic psychotic disorders or bipolar type 1 disorder
- Metal in the brain
- Pregnancy
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 |
|---|---|---|
| tDCS5 sessions of 20-minute tDCS at 2 mA over the dorsolateral prefrontal cortex (35cm² sponge) | Device | Craving, Depressive symptoms, Early relapse (2-week follow-up), Working memory |
Primary outcome
Relapse rate 2 weeks after discharge
Time frame: 2-week follow-up
by phone call; more than 60 g of alcohol
Relapse rate 1 month after discharge
Time frame: 1-month follow-up
by phone call; more than 60 g of alcohol
Relapse rate 3 months after discharge
Time frame: 3-month follow-up
by phone call; more than 60 g of alcohol
8 secondary outcomes
Craving
Time frame: at pre-intervention (day 12 of hospitalization)
Craving
Time frame: at post-intervention (day 22 of hospitalization)
Working memory
Time frame: at pre-intervention (day 12 of hospitalization)
Working memory
Time frame: at post-intervention (day 22 of hospitalization)
Depressive symptoms
Time frame: at pre-intervention (day 12 of hospitalization)
Depressive symptoms
Time frame: at post-intervention (day 22 of hospitalization)
Anxiety state
Time frame: at pre-intervention (day 12 of hospitalization)
Anxiety state
Time frame: at post-intervention (day 22 of hospitalization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: Yes
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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.
Dubuson Macha, MA principal investigator
Université Libre de Bruxelles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Active tDCS and Sham tDCS, run by Brugmann University Hospital at 1 site in Belgium.
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 6 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: finished, as of the sponsor's last update on 29 Sep 2022. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse rate 2 weeks after discharge (time frame: 2-week follow-up). The study lists 3 primary outcomes in all. 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 29 Sep 2022.