RecruitingNot ApplicableNCT05997212

Effect of Repetitive TMS on Executive Function in Alcohol Use Disorder

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


Sponsor

Universidad Nacional Autonoma de Mexico

Enrollment

44 participants

Start Date

Mar 16, 2024

Study Type

INTERVENTIONAL

Conditions

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 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

Min Age: 25 YearsMax Age: 59 Years

Inclusion Criteria9

  • 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.
  • 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.

Exclusion Criteria11

  • 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.
  • 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.

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Interventions

DEVICERepetitive Transcranial Magnetic Stimulation

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.

DEVICERepetitive Transcranial Magnetic Stimulation (Sham)

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.


Locations(1)

Unidad de Resonancia Magnética

Querétaro City, Querétaro, Mexico

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NCT05997212


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