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
1 other identifier
interventional
44
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2023
CompletedFirst Posted
Study publicly available on registry
August 18, 2023
CompletedStudy Start
First participant enrolled
March 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
ExpectedFebruary 10, 2025
February 1, 2025
1.3 years
August 10, 2023
February 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Wisconsin Card Sorting Task
Measured by Wisconsin Card Sorting Task (WCST) to evaluate cognitive flexibility
Baseline, 4 weeks
Change STROOP effect
Measured by STROOP test to evaluate control inhibition
Baseline, 4 weeks
Change Visoespatial Memory
Measured by Visoespatial Memory test to evaluate visoespatial memory
Baseline, 4 weeks
Secondary Outcomes (9)
Change in Taskswitching Task Switch cost
Baseline, 4 weeks
Change in Flanker Task Flanker Efect
Baseline, 4 weeks
Change in Nback Task accuracy
Baseline, 4 weeks
Change in Alcohol Craving (VAS)
Baseline, 4 weeks, 6 months
Changes in psychopathological symptoms
Baseline, 4 weeks, 6 months
- +4 more secondary outcomes
Study Arms (2)
Active rTMS frequency at 10 Hz
EXPERIMENTALThe 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.
Sham rTMS frequency at 10 Hz
SHAM 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unidad de Resonancia Magnética
Querétaro City, Querétaro, 76230, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eduardo A Garza-Villarreal, MD, PhD
Universidad Nacional Autonoma de Mexico
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single blind. The participants will be the only ones blinded. For placebo or sham we are using vertex as the non-clinical target.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 10, 2023
First Posted
August 18, 2023
Study Start
March 16, 2024
Primary Completion
July 1, 2025
Study Completion (Estimated)
November 1, 2026
Last Updated
February 10, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- Data will be shared once the study is finished and published, aproximately in 2027
- Access Criteria
- open access
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.