Using repetitive TMS to improve thinking skills in people with alcohol use disorder
Effect of Repetitive Transcranial Magnetic Stimulation on the Executive Function in Alcohol Use Disorder
This study is testing whether a special brain treatment can help improve thinking skills in people who have stopped drinking alcohol.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 25 Years to 59 Years |
| Sex | All |
| Sponsor | Universidad Nacional Autonoma de Mexico Academic / other |
| Locations | 1 site (Querétaro City, Querétaro) |
| Trial ID | NCT05997212 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of high-frequency repetitive transcranial magnetic stimulation (rTMS) on improving executive functions in individuals with alcohol use disorder (AUD) who have been abstinent for a period of time. The research aims to address cognitive impairments associated with AUD, particularly focusing on cognitive flexibility, which is crucial for adaptive behavior. Participants will undergo rTMS treatment while their cognitive functions are assessed to determine the efficacy of this intervention in enhancing their mental capabilities. The study is conducted at a specialized facility in Querétaro, Mexico.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 25 to 59 who have been abstinent from alcohol for 8 weeks to 5 years and meet specific criteria for alcohol use disorder.
Not a fit: Patients with severe neuropsychiatric conditions, a history of epilepsy, or other significant medical issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance cognitive functions in individuals recovering from alcohol use disorder, potentially reducing relapse rates.
How similar studies have performed: While the use of rTMS in treating cognitive impairments in AUD is promising, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Querétaro City, Querétaro
- Unidad de Resonancia Magnética — Querétaro City, Querétaro, Mexico (Recruiting)
Study contacts
- Principal investigator: Eduardo A Garza-Villarreal, MD, PhD — Universidad Nacional Autonoma de Mexico
- Study coordinator: Alejandra Lopez Castro, MD, MSc
- Email: alejandraloc@comunidad.unam.mx
- Phone: +524422381038
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.