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Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence

Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02557815
Enrollment
80
Registered
2015-09-23
Start date
2012-02-29
Completion date
Unknown
Last updated
2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Dependence

Keywords

Repetitive Transcranial Magnetic Stimulation, Emotion Regulation, Craving

Brief summary

This current project investigates the effect of a single session of right dlPFC repetitive transcranial magnetic stimulation on emotion regulation abilities and craving in alcohol dependent patients and healthy controls.

Interventions

DEVICERepetitive Transcranial Magnetic Stimulation

Repetitive 10Hz right DLPFC stimulation using Magstim TMS apparatus

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Alcohol Dependence * Currently abstinent

Exclusion criteria

* psychoactive medication * not eligible for MRI (metals or claustrophobia) * (familial) history of epilepsy * current psychiatric disorders (besides alcohol dependence)

Design outcomes

Primary

MeasureTime frameDescription
Change in BOLD response during an emotion regulation task (fMRI)Change in BOLD response from baseline, compared to BOLD response after stimulation (approximately two weeks later)BOLD response was measured during an emotion regulation task. The change in BOLD response between sessions is the primary outcome for this study

Secondary

MeasureTime frameDescription
Change in experienced emotion during an emotion regulation task with Visual Analogue Scales (VAS)Change in experienced emotion from baseline, and after the stimulation session (approximately two weeks later)Participants were instructed to either 'attend' or 'regulate' their emotion associated with the presented (negatively valenced) pictures. Experienced (or regulated) emotion was assessed with visual analogue scales (VAS).
Change in craving levels [Alcohol Urge Questionnaire (AUQ)]Before and after the emotion regulation task, during both baseline and stimulation session (e.g. 4 time points, sessions were separated by approximately two weeks)The AUQ was administered in order to assess craving levels. The AUQ consists of eight statements wich are rated on a 7 point likert scale \[0 = Strongly disagree, 6 = Strongly Agree\]

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026