Alcohol Use DisorderNCT05062369
Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
A study testing TaskFlow Transcranial Electrical Stimulation device and Executive Function Focused Cognitive Training in people with Alcohol Use Disorder and Addiction, run by University of Minnesota at 1 site in United States.
Trial summary
The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches using transcranial direct current stimulation (tDCS) for new treatments for alcohol use disorder (AUD) that support… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Addiction
- What is being tested?
- TaskFlow Transcranial Electrical Stimulation device and Executive Function Focused Cognitive Training
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2022to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Meet the Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for AUD
- Abstinent from alcohol use
- Must have the intention to remain in the Lodging Plus program until the end of the intervention portion of the study.
Who cannot join
- Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV)
- A head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
- Any contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder)
- Any primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder); Participants with other treated and stable psychiatric disorders will be included
- Presence of a condition that would render study measures difficult or impossible to administer or interpret
- Primary current substance use disorder diagnosis on a substance other than alcohol except for caffeine or nicotine
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- Clinical evidence for Wernicke-Korsakoff syndrome
- Left-handedness
- Entrance to the treatment program under a court mandate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clarista Berg contact
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches using transcranial direct current stimulation (tDCS) for new treatments for alcohol use disorder (AUD) that support long-term abstinence. This study will allow the investigators to discern whether the pairing of dorsolateral prefrontal cortex (DLPFC) stimulation and cognitive training can lead to improved treatment outcomes as it pertains to executive functioning and maintenance of abstinence. This paired-neuromodulation approach can potentially be used as a therapeutic intervention to decrease relapse probability in addiction. The long-term goal is to develop new addiction treatments that support long-term abstinence. The exploratory goal of this research is to associate genotypes and epigenetic changes with variations in intervention response and clinical outcome. Individual differences in baseline genetic profiles or epigenetic changes over the course of treatment could be associated with treatment response variability.
- Conditions
- Alcohol Use Disorder, Addiction
- Being tested
- TaskFlow Transcranial Electrical Stimulation device, Executive Function Focused Cognitive Training
- Medical subject headings
- Alcoholism, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaskFlow Transcranial Electrical Stimulation deviceDevice
Also called Transcranial Direct Current Stimulation (tDCS), TaskFlow-TES
The TaskFlow Transcranial Electrical Stimulation device (TaskFlow-TES) is a custom brain stimulation device developed in-house at the University of Minnesota. Each tDCS intervention will last 20 minutes of either (i) 10 active (2-mA) or (ii) 5 active and 5 sham transcranial direct current stimulation (tDCS) over the course of 10 treatment sessions.
Executive Function Focused Cognitive TrainingBehavioural
Working memory focused training occurs on a computer and consists of a variety of exercises selected to (i) place demands on the executive and storage functions of working memory (ii) adapt to challenge the participant's current ability level, (iii) provide ongoing feedback, and (iv) present novel stimuli across verbal, visual and spatial modalities. Training tasks are developed in-house. Tasks for each participant are delivered from and responses, audio, and video are stored on the HST server. The aim of using multiple tasks that require executive functions is to engage brain network functional connectivity in a number of different ways to promote generalization. Investigators will monitor each participant's training and customize the intervention to balance challenge and engagement. In addition, pre- and post-intervention, participants will perform 4-minute versions of a word and a spatial 3-back task identical across all weeks (but differing from the assessment versions).
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving active transcranial direct current stimulation (tDCS) | Experimental | Participants in this group will receive 5 sessions of active transcranial direct current stimulation (tDCS) to dorsolateral prefrontal cortex (DLPFC) while in the Lodging Plus treatment program and then 5 remote sessions of active tDCS to DLPFC after discharge from the treatment program. All participants will engage in executive functioning tasks for cognitive training during tDCS intervention (active or sham) to prime the engagement of the nucleus accumbens prefrontal cortex circuit. All participants will complete 4 MRI sessions. Craving measures will be collected before the first and after the last day of tDCS sessions. Follow-up interviews will be conducted monthly during a 4-month follow-up period after intervention completion to query relapse status. The first two follow-up interviews, at approximately 1- and 2-months post-intervention, will also include collection of cognition data. Receives: Device: TaskFlow Transcranial Electrical Stimulation device; Behavioral: Executive Function Focused Cognitive Training |
| Participants receiving active and sham active transcranial direct current stimulation (tDCS) | Sham comparator | Participants in this group will receive 5 sessions of sham-tDCS sessions while in the Lodging Plus treatment program and then 5 remote sessions of active-tDCS to DLPFC after discharge from the treatment program. All participants will engage in executive functioning tasks for cognitive training during tDCS intervention (active or sham) to prime the engagement of the nucleus accumbens prefrontal cortex circuit. All participants will complete 4 MRI sessions. Craving measures will be collected before the first and after the last day of tDCS sessions. Follow-up interviews will be conducted monthly during a 4-month follow-up period after intervention completion to query relapse status. The first two follow-up interviews, at approximately 1- and 2-months post-intervention, will also include collection of cognition data. Receives: Device: TaskFlow Transcranial Electrical Stimulation device; Behavioral: Executive Function Focused Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Timeline Followback Questionnaire relapse rates
The Timeline Followback Questionnaire will be used to assess relapse status as a binary, (has or has not relapsed), at 1, 2, 3, and 4 months over the follow-up period. This is a measure of feasibility.
Measured: Up to 4 months post-intervention
Difference in Timeline Followback Questionnaire abstinence period length
The Timeline Followback Questionnaire will be used to assess length of abstinence period measured in days at 1, 2, 3 and 4 months over the follow-up period. This is a measure of feasibility.
Measured: Up to 4 months post-intervention
Change in D-KEFS Trail Making (1-5) score
The D-KEFS Trail Making (1-5) assessment will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the D-KEFS Trail Making score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.
Measured: Up to 4 months post-intervention
Change in D-KEFS Color Word score
The D-KEFS Color-Word Interference assessment will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the D-KEFS Color Word score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.
Measured: Up to 4 months post-intervention
Change in Digit Span (WAIS IV) score
The Digit Span (WAIS IV) assessment will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the Digit Span (WAIS) score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.
Measured: Up to 4 months post-intervention
Change in D-KEFS Verbal Frequency score
The D-KEFS Verbal Frequency assessment will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the D-KEFS Verbal Frequency score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.
Measured: Up to 4 months post-intervention
Change in Digit Symbol (WAIS IV) score
The Digit Symbol (WAIS IV) assessment, also known as Coding, will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the Digit Symbol (WAIS) score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.
Measured: Up to 4 months post-intervention
Change in functional connectivity
Participants will undergo MRI at rest and fMRI scan while conducting the N-back task pre-intervention, mid-intervention, after 10 tDCS interventions, and post-intervention. The unitless average difference will be reported.
Measured: Day 3, Day 9, Day 17, and 1 month
Change in task-evoked functional magnetic resonance signal
Participants will undergo MRI at rest and fMRI scan while conducting the N-back task pre-intervention, mid-intervention, after 10 tDCS interventions, and post-intervention. The unitless average difference will be reported.
Measured: Day 3, Day 9, Day 17, and 1 month
Number of transcranial direct current stimulation (tDCS) sessions completed
The number of tDCS sessions completed will be reported as a unitless average value as a measure of feasibility.
Measured: Days 4-16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start3 Mar 2022
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jazmin Camchong, PhD, Principal investigator, Univeristy of Minnesota Department of Psychiatry & Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062369
- Sponsor's protocol ID
- STUDY00013676
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
- ClinicalTrials.gov ID
- NCT05062369
- Acronym / sponsor ID
- STUDY00013676
- Conditions
- Alcohol Use Disorder, Addiction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 30 Sep 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.
The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches using transcranial direct current stimulation (tDCS) for new treatments for alcohol use disorder (AUD) that support long-term abstinence. This study will allow the investigators to discern whether the pairing of dorsolateral prefrontal cortex (DLPFC) stimulation and cognitive training can lead to improved treatment outcomes as it pertains to executive functioning and maintenance of abstinence. This paired-neuromodulation approach can potentially be used as a therapeutic intervention to decrease relapse probability in addiction. The long-term goal is to develop new addiction treatments that support long-term abstinence. The exploratory goal of this research is to associate genotypes and epigenetic changes with variations in intervention response and clinical outcome. Individual differences in baseline genetic profiles or epigenetic changes over the course of treatment could be associated with treatment response variability.
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 |
|---|---|---|
| Participants receiving active transcranial direct current stimulation (tDCS) | Experimental | Device: TaskFlow Transcranial Electrical Stimulation device, Behavioral: Executive Function Focused Cognitive TrainingParticipants in this group will receive 5 sessions of active transcranial direct current stimulation (tDCS) to dorsolateral prefrontal cortex (DLPFC) while in the Lodging Plus treatment program and then 5 remote sessions of active tDCS to DLPFC after discharge from the treatment program. All participants will engage in executive functioning tasks for cognitive training during tDCS intervention (active or sham) to prime the engagement of the nucleus accumbens prefrontal cortex circuit. All participants will complete 4 MRI sessions. Craving measures will be collected before the first and after the last day of tDCS sessions. Follow-up interviews will be conducted monthly during a 4-month follow-up period after intervention completion to query relapse status. The first two follow-up interviews, at approximately 1- and 2-months post-intervention, will also include collection of cognition data. |
| Participants receiving active and sham active transcranial direct current stimulation (tDCS) | Sham comparator | Device: TaskFlow Transcranial Electrical Stimulation device, Behavioral: Executive Function Focused Cognitive TrainingParticipants in this group will receive 5 sessions of sham-tDCS sessions while in the Lodging Plus treatment program and then 5 remote sessions of active-tDCS to DLPFC after discharge from the treatment program. All participants will engage in executive functioning tasks for cognitive training during tDCS intervention (active or sham) to prime the engagement of the nucleus accumbens prefrontal cortex circuit. All participants will complete 4 MRI sessions. Craving measures will be collected before the first and after the last day of tDCS sessions. Follow-up interviews will be conducted monthly during a 4-month follow-up period after intervention completion to query relapse status. The first two follow-up interviews, at approximately 1- and 2-months post-intervention, will also include collection of cognition data. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meet the Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for AUD
- Abstinent from alcohol use
- Must have the intention to remain in the Lodging Plus program until the end of the intervention portion of the study.
Key exclusion criteria (9 listed)
- Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV)
- A head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
- Any contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder)
- Any primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder); Participants with other treated and stable psychiatric disorders will be included
- Presence of a condition that would render study measures difficult or impossible to administer or interpret
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 |
|---|---|---|
| TaskFlow Transcranial Electrical Stimulation deviceAlso: Transcranial Direct Current Stimulation (tDCS), TaskFlow-TESThe TaskFlow Transcranial Electrical Stimulation device (TaskFlow-TES) is a custom brain stimulation device developed in-house at the University of Minnesota. Each tDCS intervention will last 20 minutes of either (i) 10 active (2-mA) or (ii) 5 active and 5 sham transcranial direct current stimulation (tDCS) over the course of 10 treatment sessions. | Device | Participants receiving active and sham active transcranial direct current stimulation (tDCS), Participants receiving active transcranial direct current stimulation (tDCS) |
| Executive Function Focused Cognitive TrainingWorking memory focused training occurs on a computer and consists of a variety of exercises selected to (i) place demands on the executive and storage functions of working memory (ii) adapt to challenge the participant's current ability level, (iii) provide ongoing feedback, and (iv) present novel stimuli across verbal, visual and spatial modalities. Training tasks are developed in-house. Tasks for each participant are delivered from and responses, audio, and video are stored on the HST server. The aim of using multiple tasks that require executive functions is to engage brain network functional connectivity in a number of different ways to promote generalization. Investigators will monitor each participant's training and customize the intervention to balance challenge and engagement. In addition, pre- and post-intervention, participants will perform 4-minute versions of a word and a spatial 3-back task identical across all weeks (but differing from the assessment versions). | Behavioural | Participants receiving active and sham active transcranial direct current stimulation (tDCS), Participants receiving active transcranial direct current stimulation (tDCS) |
Primary outcome
Difference in Timeline Followback Questionnaire relapse rates
Time frame: Up to 4 months post-intervention
The Timeline Followback Questionnaire will be used to assess relapse status as a binary, (has or has not relapsed), at 1, 2, 3, and 4 months over the follow-up period. This is a measure of feasibility.
Difference in Timeline Followback Questionnaire abstinence period length
Time frame: Up to 4 months post-intervention
The Timeline Followback Questionnaire will be used to assess length of abstinence period measured in days at 1, 2, 3 and 4 months over the follow-up period. This is a measure of feasibility.
Change in D-KEFS Trail Making (1-5) score
Time frame: Up to 4 months post-intervention
The D-KEFS Trail Making (1-5) assessment will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the D-KEFS Trail Making score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.
Change in D-KEFS Color Word score
Time frame: Up to 4 months post-intervention
The D-KEFS Color-Word Interference assessment will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the D-KEFS Color Word score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.
Change in Digit Span (WAIS IV) score
Time frame: Up to 4 months post-intervention
The Digit Span (WAIS IV) assessment will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the Digit Span (WAIS) score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.
Change in D-KEFS Verbal Frequency score
Time frame: Up to 4 months post-intervention
The D-KEFS Verbal Frequency assessment will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the D-KEFS Verbal Frequency score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.
Change in Digit Symbol (WAIS IV) score
Time frame: Up to 4 months post-intervention
The Digit Symbol (WAIS IV) assessment, also known as Coding, will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the Digit Symbol (WAIS) score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.
Change in functional connectivity
Time frame: Day 3, Day 9, Day 17, and 1 month
Participants will undergo MRI at rest and fMRI scan while conducting the N-back task pre-intervention, mid-intervention, after 10 tDCS interventions, and post-intervention. The unitless average difference will be reported.
Change in task-evoked functional magnetic resonance signal
Time frame: Day 3, Day 9, Day 17, and 1 month
Participants will undergo MRI at rest and fMRI scan while conducting the N-back task pre-intervention, mid-intervention, after 10 tDCS interventions, and post-intervention. The unitless average difference will be reported.
Number of transcranial direct current stimulation (tDCS) sessions completed
Time frame: Days 4-16
The number of tDCS sessions completed will be reported as a unitless average value as a measure of feasibility.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Clarista Berg contact
Jazmin Camchong, PhD principal investigator
Univeristy of Minnesota Department of Psychiatry & Behavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TaskFlow Transcranial Electrical Stimulation device and Executive Function Focused Cognitive Training in people with Alcohol Use Disorder and Addiction, run by University of Minnesota at 1 site in United States.
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 9 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jazmin Camchong, PhD ((612) 842-8704, camch002@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Timeline Followback Questionnaire relapse rates (time frame: Up to 4 months post-intervention). The study lists 10 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 7 Oct 2026.