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Effect of Repetitive TMS on Executive Function in Alcohol Use Disorder

ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-59
SponsorUniversidad Nacional Autonoma de Mexico

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation

    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 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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Active rTMS frequency at 10 HzExperimental treatment 1 intervention
Group B: Sham rTMS frequency at 10 HzSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Wisconsin Card Sorting Task

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

Time frame
Baseline, 4 weeks
2

Change STROOP effect

Measured by STROOP test to evaluate control inhibition

Time frame
Baseline, 4 weeks
3

Change Visoespatial Memory

Measured by Visoespatial Memory test to evaluate visoespatial memory

Time frame
Baseline, 4 weeks

Secondary outcomes

1

Change in Taskswitching Task Switch cost

Measured by Taskswitching task to evaluate cognitive flexibility

Time frame
Baseline, 4 weeks
2

Change in Flanker Task Flanker Efect

Measured by Flanker task to evaluate control inhibition

Time frame
Baseline, 4 weeks
3

Change in Nback Task accuracy

Measured by Nback task to evaluate working memory

Time frame
Baseline, 4 weeks
4

Change in Alcohol Craving (VAS)

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

Time frame
Baseline, 4 weeks, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Nacional Autonoma de Mexico

Lead sponsor

National Council of Science and Technology, Mexico

Collaborator

Source ClinicalTrials.gov
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