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Alcohol Use DisorderNCT05997212

Effect of Repetitive TMS on Executive Function in Alcohol Use Disorder

A study testing Repetitive Transcranial Magnetic Stimulation in people with Alcohol Use Disorder, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Alcohol Use Disorder (AUD) is a major public health problem that affects the physical, social, family, and mental integrity of the sufferer. Behavioral self-regulation is compromised in AUD, and a benefit has been reported with the application of repetitive transcranial magnetic stimulation and emotional… Read more about this study

Who is it for?
Ages 25 to 59 years
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Repetitive Transcranial Magnetic Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteMexico
Study dates
16 Mar 2024to 1 Nov 2026
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 25 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Men and women of 25 to 59 years old
  • The reading level of at least 6th grade of primary (equivalent to fifth grade of elementary school).
  • Alcohol users with and AUDIT ≥ 20 puntos
  • Abstinence from alcohol consumption from 8 weeks to 5 years, with CIWA-Ar scale scores ≤ 9 points.
  • No disabling neuropsychiatric conditions (i.e. Schizophrenia)
  • No substance use disorders except alcohol and nicotine.
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  • BrAC (Breath Alcohol) = 0.00 mg/dl in each of the assessments.
  • No traces of alcohol consumption using urine test strips.
  • No contraindications for TMS therapy.

Who cannot join

  • Individuals with symptoms of severe agitation or who are unable to cooperate in the study
  • History of epilepsy
  • Sudden onset of stroke, focal neurological findings such as hemiparesis, sensory loss, visual field deficits and lack of coordination.
  • Seizures or gait disturbances
  • History of severe psychiatric disorders.
  • Alterations in a conventional electroencephalogram.
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  • Pacemakers or intracranial metallic objects.
  • Elimination criteria
  • At the subject's request
  • The presence of adverse incidents that deteriorate the subject's health and would limit continuation of rTMS treatment.
  • Exacerbation of cognitive or behavioral symptoms during treatment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alejandra Lopez Castro, MD, MSc contact

+524422381038

alejandraloc@comunidad.unam.mx

Mexico1 site, 1 recruiting
  • Unidad de Resonancia Magnética

    Querétaro City, Querétaro, 76230

    Alejandra Lopez Castro, MD, MSc, 4422381038, alejandraloc@comunidad.unam.mx

    Eduardo A Garza Villarreal, MD, PhD

    Recruiting

Other trials in Mexico

About this study

Official title: Effect of Repetitive Transcranial Magnetic Stimulation on the Executive Function in Alcohol Use Disorder

Alcohol Use Disorder (AUD) is a major public health problem that affects the physical, social, family, and mental integrity of the sufferer. Behavioral self-regulation is compromised in AUD, and a benefit has been reported with the application of repetitive transcranial magnetic stimulation and emotional self-regulation. The aim of this study is to investigate the efficacy of high-frequency rTMS to improve executive functions in patients in abstinence from AUD.

Read the detailed description

It is proposed that individuals predisposed to developing alcohol use disorder (AUD) exhibit alterations in executive functions, resulting from maladaptive cellular homeostatic processes and neuronal circuits activated by substance use. These alterations persist even after substance withdrawal (Nestler \& Aghajanian, 1997). As a multifactorial disorder, AUD has been linked to family history of alcohol use (Khemiri et al., 2020; Peterson et al., 1990; Tarter et al., 1989) and individual traits such as poor cognitive test performance relative to controls (Shnitko et al., 2018; Goudriaan et al., 2011), which may predict heavy alcohol consumption or AUD development.

These executive dysfunctions manifest as persistent negative behaviors that impede adaptive learning and reduced activation of the executive control network, both of which correlate with AUD severity (Mayhugh et al., 2014). Cognitive flexibility, a key executive function, enables adaptive adjustment of thoughts and behaviors in response to environmental demands (Uddin, 2021). Impaired cognitive flexibility is associated with AUD persistence and severity (Stalnaker et al., 2008), though recovery is observed after prolonged abstinence (Rourke \& Grant, 1999). Thus, cognitive flexibility may serve as a promising treatment biomarker.

McLellan et al. (2000) report that 40-60% of AUD patients relapse within the first year post-treatment, while at least 60% relapse within six months (Durazzo \& Meyerhoff, 2017; Kirshenbaum et al., 2009; Maisto et al., 2006a; Meyerhoff \& Durazzo, 2010). Given these challenges, non-invasive neuromodulation techniques like repetitive transcranial magnetic stimulation (rTMS) have emerged as adjunct therapies to standard treatments (Diana et al., 2017). For example, Addolorato et al. (2017) applied high-frequency (10 Hz) rTMS to the dorsolateral prefrontal cortex (DLPFC) in AUD patients and observed reduced alcohol consumption and increased abstinent days. Similarly, Del Felice et al. (2016) found that left DLPFC stimulation enhanced inhibitory control, selective attention, and mood in active alcohol users.

Stimulating the DLPFC, a hub of the executive control network, may enhance its functional connectivity and improve cognitive flexibility in AUD patients. These effects align with findings that rTMS bolsters inhibitory control and attention (Del Felice et al., 2016; Diana et al., 2017). To explore this further, we propose a longitudinal study assessing cognitive/behavioral traits in AUD patients that may contribute to disorder development. We will also evaluate rTMS effects using neuropsychological tools and MRI to measure structural/functional brain changes.

This study aims to investigate the short- and long-term clinical and cognitive effects of 10 Hz rTMS applied to the left DLPFC in abstinent AUD patients, alongside associated neurostructural and functional connectivity changes. Abstinent AUD patients will receive daily rTMS for four weeks. Clinical outcomes will be tracked for six months, with cognitive, structural, and functional connectivity measurements taken at baseline, post-intervention (4 weeks), and follow-up (6 months).

Being tested
Repetitive Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation (Sham)
Keywords
mri, rtms, tms, repetitive transcranial magnetic stimulation, mexico, magnetic resonance imaging, executive function
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Repetitive Transcranial Magnetic StimulationDevice

    The investigators will use a Magstim Rapid 2 stimulator, Airfilled coil (AFC), 8 shape (magnetic field of 0.8 Teslas, 3Kg, pulse 0.5 ms)

    Each patient will receive high frequency 10 Hz stimulation at 100% of motor threshold over the dorsolateral prefrontal cortex (DLPFC) at 1500 pulses per session with 30 trains of 5 seconds and 0.5 ms stimuli and an inter-train distance of 15 seconds. In 2 daily sessions 4 days a week for 4 weeks.

  • Repetitive Transcranial Magnetic Stimulation (Sham)Device

    The investigators will use a Magstim Rapid 2 stimulator, Airfilled coil (AFC), 8 shape (magnetic field of 0.8 Teslas, 3Kg, pulse 0.5 ms)

    Each patient will receive consistent treatment in 2 sessions a day for 20 consecutive business days for 4 weeks. The coil will be placed on the vertex target location.

Study groups in NCT05997212
Study groupRoleWhat they receive
Active rTMS frequency at 10 HzExperimentalThe intervention will be Repetitive Transcranial Magnetic Stimulation. Each patient will receive treatment stimulation in the left dorsolateral prefrontal cortex (lDLPFC) with a frequency of 10 Hz, that includes 2 sessions per day for 20 consecutive business days for 4 weeks. Each session will consist of the application of rTMS at a frequency of 10 Hz, to 100% of the motor threshold. The lDLPFC target will be determined using their resting state functional connectivity between anterior cingulate cortex and lDLPFC. Our algorithm performs a calculation of the individual localization of the participant's lDLPFC, which will be used for the whole study in that particular participant.
Receives: Device: Repetitive Transcranial Magnetic Stimulation
Sham rTMS frequency at 10 HzSham comparatorThe intervention will be Repetitive Transcranial Magnetic Stimulation (Sham). For this patients the coil will be located on the vertex. Each patient will receive sham stimulation with a frequency of 10 Hz, that includes 2 sessions per day for 20 consecutive business days for 4 weeks. Each session will consist of the application of rTMS at a frequency of 10 Hz, to 100% of the motor threshold. The lDLPFC target will be determined using their resting state functional connectivity between anterior cingulate cortex and lDLPFC. Our algorithm performs a calculation of the individual localization of the participant's lDLPFC, which will be used for the whole study in that particular participant.
Receives: Device: Repetitive Transcranial Magnetic Stimulation (Sham)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Wisconsin Card Sorting Task

    Measured by Wisconsin Card Sorting Task (WCST) to evaluate cognitive flexibility

    Measured: Baseline, 4 weeks

  2. Change STROOP effect

    Measured by STROOP test to evaluate control inhibition

    Measured: Baseline, 4 weeks

  3. Change Visoespatial Memory

    Measured by Visoespatial Memory test to evaluate visoespatial memory

    Measured: Baseline, 4 weeks

Secondary outcomes (9)
  1. Change in Taskswitching Task Switch cost

    Measured by Taskswitching task to evaluate cognitive flexibility

    Measured: Baseline, 4 weeks

  2. Change in Flanker Task Flanker Efect

    Measured by Flanker task to evaluate control inhibition

    Measured: Baseline, 4 weeks

  3. Change in Nback Task accuracy

    Measured by Nback task to evaluate working memory

    Measured: Baseline, 4 weeks

  4. Change in Alcohol Craving (VAS)

    The craving will be measured using a 100 mm visual analogue scales

    Measured: Baseline, 4 weeks, 6 months

  5. Changes in psychopathological symptoms

    Measured by the Symptoms Questionnaire 90 (SCL-90)

    Measured: Baseline, 4 weeks, 6 months

  6. Changes in WHODAS score

    Measured by Disability Assessment Schedule (WHODAS)

    Measured: Baseline, 4 weeks, 6 months

  7. Changes in Anxiety

    Measured by Hamilton Anxiety Rating Scale (HARS)

    Measured: Baseline, 4 weeks, 6 months

  8. Changes in Depression

    Measured by Hamilton Depression Rating Scale (HDRS)

    Measured: Baseline, 4 weeks, 6 months

  9. Changes in functional connectivity

    Functional connectivity of the dorsolateral prefrontal with the anterior cingulate cortex, measured with fMRI defined by the temporal correlation in the blood-oxygen-level-dependent signals of the regions. Higher correlations indicate stronger functional connectivity.

    Measured: Baseline, 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2023
  2. Study start16 Mar 2024
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

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
Single-blind randomize clincial trial with parallel groups.
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05997212
Sponsor's protocol ID
101.H
Status last verified
Feb 2025
First submitted
10 Aug 2023
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All clinical and MRI data will be shared with each patient's written consent. Identification information will not be shared, only the RID, and all MRI structural data will be defaced prior to sharing. MRI data will be uploaded to Open Neuro while the clinical data will be uploaded to Zenodo.

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive Transcranial Magnetic Stimulation in people with Alcohol Use Disorder, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.

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 9 inclusion and 11 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 10 Feb 2025. 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 Mexico. 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 Alejandra Lopez Castro, MD, MSc (+524422381038, alejandraloc@comunidad.unam.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Wisconsin Card Sorting Task (time frame: Baseline, 4 weeks). 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 10 Feb 2025.

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